Clinical performance of piezoelectric surgery vs conventional

surgery in lateral maxillary sinus elevation and graft. Analysis of

the incidence of intra-operative and post-operative complication-
A review of systematic review and metanalysis

Research Dissertation

2020

Submitted to BPP University College as a requisite for Mclindent

Periodontology

Mohammad Haris

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SUPERVISORS

Dr. Flavio Pisani

Dissertation Supervisor

Specialist in Oral Surgery

Senior Lecturer

Faculty of Dentistry School of Health BPP University

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Declaration
I declare that the information incorporated in this dissertation is my own work
and it has not been published in the past.

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Dedication

I would like to express my love and gratitude to my parents and my teachers,

without whom this would not have come into existence. As the teacher and the
taught together create the teaching.

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Acknowledgment

To all my colleagues, educators, supervisor, BPP university who have motivated and
guided me throughout my career and research.

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 I. List of tables
Table 3. 1: Classification of maxillary sinus (Kumar and Anand, 2016)............. 27
Table 3. 2: Advantages and disadvantages of Rotary instrumentation (Nicolucci,
2011).................................................................................................................. 37

Table 4. 1: Literature search strategy on PubMed............................................ 53

Table 4. 2: Search details and Mesh terms on PubMed .................................... 54

Table 5. 1: Summary of the findings of included articles (organized

chronologically) .................................................................................................. 59
Table 5. 2: Critical appraisal of Atieh et al (2015) using CASP tool (2018) ....... 64
Table 5. 3: Critical appraisal of Atieh et al (2015) using AMSTAR-2 tool (2017).
........................................................................................................................... 64
Table 5. 4: Critical appraisal of Atieh et al (2015), using ROBIS tool (2016) ..... 65
Table 5. 5: Critical appraisal of Geminiani et al (2017) using CASP tool (2018)…
........................................................................................................................... 75
Table 5. 6: Critical appraisal of Geminiani et al (2017) using AMSTAR-2 tool
(2017) ................................................................................................................ 78
Table 5. 7: Critical appraisal of Geminiani et al (2017) using ROBIS tool (2016)
........................................................................................................................... 81
Table 5. 8: Critical appraisal of Jordi et al (2018) using CASP tool (2018)........ 87
Table 5. 9: Critical appraisal of Jordi et al (2018) using AMSTAR-2 tool (2017) 91
Table 5. 10: Critical appraisal of Jordi et al (2018) using ROBIS tool (2016) .... 93
Table 5. 11: Critical appraisal of Stacchi et al (2017) using CASP tool (2018)…..
......................................................................................................................... 100
Table 5. 12: Critical appraisal of Stacchi et al (2017) using AMSTAR-2 tool
(2017) .............................................................................................................. 103
Table 5. 13: Critical appraisal of Stacchi et al (2017) using ROBIS tool (2016)
......................................................................................................................... 106

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Table 5. 14: Critical appraisal of Stacchi et al (2020) using CASP tool (2018)…..
......................................................................................................................... 112
Table 5. 15: Critical appraisal of Stacchi et al (2020) using AMSTAR-2 tool
(2017) .............................................................................................................. 115
Table 5. 16: Critical appraisal of Stacchi et al (2020) using ROBIS tool (2016)
......................................................................................................................... 118

II. List of figures

Figure 3. 1: Shows the intimacy of the relationship between the maxillary

posterior teeth and the maxillary sinus. The arrow shows the maxillary first
premolar root is located on the most medial side (Iwanaga et al, 2019) ........... 21
Figure 3. 2: Development and pneumatization of the maxillary sinus (Göçmen et
al, 2017) ............................................................................................................. 24
Figure 3. 3: Classification of maxillary sinus based on residual bone height
(Kumar and Anand, 2016) ................................................................................. 28
Figure 3. 4: Crestal approach for maxillary sinus augmentation (Kumar and
Anand, 2016) ..................................................................................................... 30
Figure 3. 5: Lateral window technique for maxillary sinus augmentation (Kumar
and Anand, 2016) .............................................................................................. 33
Figure 3. 6: Shows the lateral wall sinus kit (Garg et al, 2019).......................... 35
Figure 3. 7: Shows LA stoppers ranging from 0.5mm to 3.0mm demonstrated on
rotary bur (Garg et al, 2019) .............................................................................. 36
Figure 3. 8: Shows rotary instruments which are used with handpieces (Garg et
al, 2019) ............................................................................................................. 37
Figure 3. 9: shows the TOLA II hand instruments (Garg et al, 2019) ................ 38

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Figure 3. 10: Piezoelectric devices can contact the schneiderian membrane (left
image), Membrane elevation obtained by piezosurgery (right image) (Baldi et al,
2011).................................................................................................................. 44

Figure 3.11: Search strategy and Exclusion at different levels. ......................... 58

III. List of abbreviations

PBS-PERIODONTAL BONEY SURGERY

LASFE – LATERAL APPROACH SINUS FLOOR ELEVATION
MSA- MAXILLARY SINUS AUGMENTATION
CBCT- CONE BEAN COMPUTER TOMOGRAPHY
PED – PIEZOELECTRIC DEVICE
TSA – TRIAL SEQUENTIAL ANALYSIS
PBS - PERIODONTAL BONE SURGERY
SFE – SINUS FLOOR ELEVUATION
LMSE – Lateral Maxillary Sinus Elevation

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 IV. Table of contents

1. Abstract ....................................................................................................... 11

1.1 Background and objectives .................................................................. 11

1.2 Methods ................................................................................................ 12

1.3 Results.................................................................................................. 13

1.4 Conclusion ............................................................................................ 14

2. Introduction .............................................................................................. 14

2.1 Rationale .............................................................................................. 19

3. Background and literature review................................................................ 20

3.1 Anatomy of maxillary sinus and indications for maxillary sinus

augmentation .................................................................................................. 20

3.1.1 Indications and contraindications of maxillary sinus augmentation.... 24

3.2 Different techniques for maxillary sinus elevation ................................ 25

3.2.1 Indirect sinus augmentation approach ........................................... 28

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 3.2.2 Direct sinus augmentation approach ............................................. 30

3.2.3 Grafting materials used in maxillary sinus augmentation............... 33

3.3 ‘Rotary instrumentation’ or handpieces for maxillary sinus elevation ... 35

3.3.1 Intra-operative and post-operative complications of rotary

instrumentation and prevention ................................................................... 39

3.4 ‘Piezo-electric surgery’ for maxillary sinus elevation ............................ 41

3.5 Clinical studies on rotary instrumentation versus piezo-electric surgery

for lateral maxillary sinus augmentation ......................................................... 45

3.6 Aims and objectives.............................................................................. 49

3.6.1 Aims ............................................................................................... 49

3.6.2 Objectives ...................................................................................... 49

4. Methodology................................................................................................ 50

4.1 Study design ......................................................................................... 50

4.2 Research question................................................................................ 50

4.3 Selection criteria ................................................................................... 46

4.3.1 Inclusion ......................................................................................... 51

4.3.2 Exclusion........................................................................................ 51

4.4 Search strategy .................................................................................... 52

4.5 Selection criteria and data extraction ................................................... 56

4.6 Ethical approval .................................................................................... 57

5. Results ........................................................................................................ 57

6. Discussion ................................................................................................. 128

7. Conclusion ................................................................................................ 135

8. References ................................................................................................ 136

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1. Abstract

When it comes to edentate posterior maxilla the loss of bone volume and vertical
height from the sinus to the alveolar crest is a challenge as it renders the process
of dental implant placement. In the last three decades surgeons have purposed
various ways to enter the sinus cavity, however, the two main surgical approaches
are the external lateral window approach and internal trans alveolar approach.
Both of these morbidities have their own indications. For instance, the
recommended alveolar crest height for external lateral window approach is less
than 5mm.While above 5mm of residual alveolar crest height can be considered
for internal trans alveolar approach.
In recent years, the piezoelectric device capability of nurturing the soft and hard
tissue due to its precise cutting ability have brought about ease in handle the
fragile soft tissue. Furthermore, its ability of avoiding thermal damage results in
decreasing the chances of osteonecrosis. With the current and future prospective
of piezoelectric surgery the possibilities of performing minimally invasive and
customized osteotomies is possible. The piezoelectric device supersedes the
mechanical form of instrumentation.

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However, there is a scarcity of information when it comes to the efficacy of these
morbidities in terms of membrane perforation, operative time, grafting procedures.
Thus, the aim of the review is to explore this viewpoint further.

1.2 Background and objectives

Piezoelectric and rotary hand instrumentation are a viable option to prepare

osteotomies during lateral wall sinus surgery. The use of piezoelectric during
sinus augmentation is superior to that of rotary hand instrumentation. Perhaps
this is due to the ability of piezoelectric device to differentiate between soft and
hard tissue. However, there are few limitations in comparison of these devices.
Therefore, the aim of this review is to analysis ; The clinical efficacy of
Piezoelectric and Conventional rotary hand instrumentation in lateral maxillary
sinus elevation and graft procedures in lieu of their intra operative and post-
operative complications.

1.3 Methods

Systematic search was carried out using pre-decided keywords and the set of
inclusion and exclusion criteria in search engine ; “PubMed” to determine the
appropriate publications evolving in concert with the research question ; What is
the clinical performance of piezoelectric surgery versus conventional surgery in
lateral maxillary sinus elevation and graft procedures in regard to their intra
operative and post-operative complications?”.

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1.3 Results

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1.4 Conclusion

2 Introduction

The placement of implants in an edentulous posterior maxilla poses many

challenges for the clinician. The alveolar ridge resorption following tooth extraction
may result in loss of bone in the buccolingual or apico-coronal direction. There
may also be vertical bone loss due to post extraction sinus pneumatization. These
events can cause the minimization of the alveolar crest height in relation to the
underlying maxillary sinus thus causing difficulties in placing standard length oral
implants and requiring intervention (Atieh et al, 2015). To formulate a dental
implant prosthetic rehabilitation, it is necessary to lift the underlying sinus
membrane, subsequently creating space between the alveolar ridge and the sinus
membrane for placement of the dental implant (Atieh et al, 2015).

The augmentation of the maxillary sinus using the lateral window technique is a
predictable treatment modality for the placement of dental implant in the posterior
maxilla. This is due to the outcomes of maxillary augmentation and its relationship

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with implant survival. This technique involves the creation of a bony window in the
lateral wall of the sinus followed by a gentle elevation of the sinus membrane
lining. Autogenous particulate iliac bone may then be inserted beneath the
elevated membrane and allowed to heal for 3 months before placing the implant
(Atieh et al, 2015). By considering the implant surface characteristics, barrier
membranes and a feasible grafting material, one may expect an implant survival
of 95%. There are few chances for a complication to occur during or after the
procedure and in case they do, they can be rectified. According to Pjetursson et
al (2008) and Carreon et al (2016) systematic reviews, maxillary sinus
augmentation endures a long-term success and survival of the implants like those
that are placed in the pristine bone and this viewpoint is well documented in the
literature.

The first publication on implant placement in grafted maxillary sinus came out in
1980 (Boyne et al, 1980).This publication used autogenous cancellous bone and
marrow from the lateral iliac crest as the graft material acting as a modification of
Caldwell-luc procedure to enter the maxillary sinus. From this point onwards
several articles citied many different sinus grafting techniques and various bone
substitutes, that have influenced the outcome of sinus augmentation on implant
survival.

There are arguments regarding the best graft or combination of grafts in lieu of
sinus surgery. Studies by Wallace et al (2003), illustrated that sinus augmented
by particulate grafts illustrated an increased survival rate in contrast to those
augmented with block grafts. Browaeys et al (2007), highlighted that bovine bone
mineral act as a slow resorbing space maintainer, thus eliminating sinus
pneumatization following augmentation. Concurrently, the implant surface
characteristic and placement timing have also been argued.

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Lateral maxillary sinus floor elevation is indeed a widely accepted technique.
Implants are either placed directly after the grafting procedure or after a healing
period. High implant survival rates of 1 to 3 years have been reported with the use
of roughened implant surfaces and membrane coverage. Yet it is a technique
sensitive procedure and despite the predictability of the procedure and the high
implant survival rates, both intraoperative and post-operative complications have
been reported (Atieh et al, 2015).

Most of these complications are due to the challenges faced during the maxillary
sinus augmentation. Factors that contribute to the development of these setbacks
are due to the presence of complex anatomical structures like thin membrane,
septa, thin or convex lateral walls. The choice of less predictable treatment
options like using a conventional hand instrumentation in contrast to piezoelectric
devices (Schwartz et al, 2004)

Several intraoperative complications have been reported, such as damage to

adjacent teeth, alveolar ridge fracture, hematoma formation, wound dehiscence’s,
injury to infraorbital neurovascular bundle, implant migration into the sinus cavity
and bleeding related to the injury of the arterial anastomoses at the lateral sinus
wall area (Atieh et al, 2015 and Geminiani et al, 2017). However, the most
common intra-operative complication is the perforation of the Schneiderian
membrane. The perforation of the membrane is mostly associated with the use of
conventional rotary instrumentation (Patil and Bhongade, 2016).

The first ever lateral maxillary sinus elevation which encompasses a window
opening on the lateral aspect of the maxillary sinus was also facilitated using
rotary instrumentation; diamond or carbide burs controlled by a surgical motor.
The technique for augmentation carried out in this study can be characterized as
challenging because the normal thickness of the membrane is approximately 0.5
to 1mm and may have inter-individual variations. The data documented in
literature in terms of using rotary hand instrumentation and its correlation with
perforation varies between 5% to 56%. However, if rotary instrumentation is

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preferred for surgery, diamonds burs are more advantageous to carbide burs
because of their nature of not catching and tearing the membrane (Boyne et al,
1980).

The piezoelectric surgery, a concept of bone surgery brought about by Vercellotti

and designed for sinus elevation surgery facilitate by far a means of avoiding all
these complications and completely superseding the rotary hand instrumentation.
Evidence clearly illustrates that piezoelectric devices decrease the occurrence of
maxillary sinus floor perforation and can cut bone without any damage to soft
tissues such as dura matter, vessels and nerves. In the event a nerve is damaged,
the perineural sheath is often left intact thus preserving the potential for neural
regeneration. Piezo Electric devices also make minimal noise and vibrations
(Atieh et al, 2015). Even a surgeon with limited amount of experience may be able
to handle and perform surgeries with the piezo electric devices with ease (Seoane
et al, 2013). Perhaps, the ease of handling is due to the minimal invasive nature
of inserts in contrast to those of rotary instruments. Also, the low frequency
ultrasonic vibration ranging from 24-32 kHz for the various systems to perform
osteotomy and osteoplasty on the bone by piezoelectric device facilities an
accurate and selective cutting action thus maintaining the integrity of the soft
tissues. These devices are not capable of damaging either blood vessels or
membranes thus reducing risk of damage (Vercellotti, 2016)

Though very advantageous, piezo electric devices take five times longer than
conventional drills to carry out the same procedures (Atieh et al, 2015). Several
studies have been carried out and published on the topic of accidental
perforations of the sinus membrane following antrostomy with piezoelectric
techniques. The results varied from 4% to 31%. Other complications include intra-
operative bleeding, perforation within the buccal flap, artery laceration, soft tissue
damage and occasional damage to the infraorbital nerve. The reported incidence
for these events in literature ranged from 11% to 14% (Patil and Bhongade, 2016).

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The post-operative complications most commonly include mild to moderate
edema, ecchymosis and bleeding at incision line. There may also include graft
infections, sinus infections, postoperative sinusitis, profuse postoperative
bleeding, flap dehiscence, oroantral fistula formation, formation of inadequate
graft volume for implant placement, loss of graft material containment as a result
of sinus membrane rupture, exfoliation of graft material through the sinus window,
maxillary cyst formation, migration of dental implants into the sinus graft and a
complete dental implant failure (Patil and Bhongade, 2016). The prevalence of
these complication in order of most frequent occurrence reported by Zijderveld et
al (2008) were loss of implant (4%), wound dehiscence (3%), graft infections (2%).
Postoperative maxillary sinusitis (1%) and loss of or insufficient graft volume (1%).

When it comes to post-operative sinus graft infections there are no studies that
consider a separate entity for each graft infection, however, the overall incidence
rate is between 2-5%. The cause of this is the contamination of the surgical site;
salivary/bacterial invasion of the graft material, instruments, adjacent periapical
pathology, lapses in the chain of sterility and an increased surgical time (Sindel,
2018).

There may also be a loss of graft down the window because of increased intra
sinus pressure caused by post-operative inflammation or bleeding from within the
sinus. This may be a consequence of not placing a membrane over the window
or that the membrane was not stabilized. The displacement of the graft material
may result in an elevation of the buccal mucosa. From this point onwards either it
can be removed from a small flap entry (not over window or membrane) or it can
be removed at the time of implant placement. The incidence of this complication
is low. However, to prevent such an event from happening, the placement of a
barrier membrane may be a good practice. Here the choice of membrane should
be the one that becomes flexible when it contacts water as this will help the
membrane to shape itself on the lateral wall (Patil and Bhongade, 2016).

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Today, maxillary sinus floor augmentation is a predictable treatment, which yields
excellent results regarding implant survival rates. It is successful in both partially
and fully edentulous patients (Ragheobar et al, 2019). Irrespective of the grafting
material applied, sinus floor elevation results in limited peri-implant marginal bone
loss and few complications. By using piezoelectric devices, a good access to the
underlying membrane and precise cutting of hard tissue without damaging the soft
tissue can be attained. These devices also induce less heat generation, therefore,
reducing the chances of osteonecrosis. Even vitality of adjacent tissues is
sustained with their use. Thus, they are advantageous for the surgeon as they
bring about ease in sinus elevation with reduced amount of complications. As a
result, the procedure is comfortable for the patient and provides them with ease
while simultaneously reducing surgical trauma and promoting rapid healing (Atieh
et al, 2015).

2.3 Rationale

As per the research and data available in the field of evidence-based dentistry, it
can be assumed that piezo electric surgery seems to be a viable treatment option
as compared to conventional surgery for sinus augmentation based on the
analysis of their intraoperative and postoperative complications. Surgeries
performed with piezo electric devices have reduced chances of sinus membrane
perforation, have increased implant survival rates and have more precision and
accuracy in bone cutting. They also provide the clinician with ease in handling,
regardless of the experience of the surgeon. Despite the numerous advantages
of surgeries performed by piezo electric devices, conventional instruments have
a reduced operational time.

This analysis seeks to close the gap in knowledge and provide clinicians with ease
in identifying the knowledge and choosing the appropriate procedures leading to
our research question: “What is the clinical performance of piezoelectric surgery

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versus conventional surgery in lateral maxillary sinus elevation and graft
procedures in regard to their intra operative and post-operative complications?”

3 Background and literature review

3.1 Anatomy of maxillary sinus and indications for maxillary sinus augmentation

The placement of dental implants in the posterior edentulous maxilla can be a

challenging procedure for the clinician. Sinus pneumatization, alveolar ridge
resorption, trauma and poor bone quality make implant placement difficult if not
unfeasible. Maxillary sinus floor elevation is a surgical procedure performed to
raise the sinus membrane allowing for the placement of a dental implant of
appropriate length. Knowledge of the anatomy of the maxillary sinus and
surrounding structures is vital for successful treatment planning, treatment
outcomes and avoiding possibilities of intraoperative complications. Despite a
high success rate, all the appropriate indications and contraindications for the
procedure need to be taken into consideration for successful treatment outcomes.
(Rahpeyma et al, 2018, Adel Helmy, 2017 and Bathla et al, 2018).

The maxillary sinus is the largest paranasal sinus and is best described as a
pyramidal shaped cavity. The base of the sinus lies adjacent to the nasal wall and
the apex extends to the zygomatic bone. The anterior wall of the sinus is the facial
surface of the maxilla while the infratemporal surface of the maxilla forms the
posterior wall. The roof of the sinus is formed by the orbital floor whereas the sinus

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floor lies below the nasal cavity and is formed by the alveolar and palatine
processes of the maxilla (Iwanaga et al 2019). The sinus has an average volume
of 15ml, with an average length of 38-45mm, a height of 36-45mm and an average
a width of 23-25mm (Bathla et al, 2018).

The sinus is lined by a bilaminar membrane known as the Schneiderian

membrane. This membrane is lined by pseudostratified ciliated columnar
epithelial cells on the internal side whereas periosteum lines the outer side. The
columnar cells each have 100-150 cilia that vibrate at a 1000 beats per minute.
The thickness of the membrane varies from 0.13 to 0.5 mm. The inferior aspect
of the sinus membrane is in close relation with the roots of the maxillary premolar
and molars, with the mesio-buccal root apex of the maxillary second molar having
a distance of 0.83mm and being closest to the sinus wall, while the premolars are
more at a distance (figure 3.1) (Iwanaga et al, 2019).

Figure 3. 1: Shows the intimacy of the relationship between the maxillary

posterior teeth and the maxillary sinus. The arrow shows the maxillary first
premolar root is located on the most medial side (Iwanaga et al, 2019)

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The likelihood of sinus membrane perforation is dependent upon the angle
between the lateral and medial walls of the sinus. Angles greater than 60° have a
0% chance of perforation, whereas angles between 30°-60° have a 28.6% chance
and <30° angles have 62.5% chances of perforation. This shows that wider angles
have fewer chances of perforation. The placement of bone graft material into the
sinus needs to done carefully as overfilling the sinus with bone graft may result in
necrosis of the membrane, sinusitis and loss of graft material into the sinus cavity
(Bathla et al, 2018).

Fin-shaped bony projections usually located between the second premolar and
first molar area are called maxillary ‘sinus septa’. They can be categorized into
primary and secondary septa. The primary septa are formed during the period of
tooth growth and maxillary development whereas the secondary septa forms as
a consequence of pneumatization following tooth loss. The presence of these
septa can complicate sinus augmentation (Bathla et al 2018).

The sinus receives its vascular supply from the branches of the maxillary artery.
The posterior superior alveolar artery and the infraorbital artery are the branches
which supply the lateral sinus wall whereas the medial wall of the sinus is supplied
by the posterior lateral nasal artery. The greater palatine artery may supply the
inferior part of the sinus. Anastomosis between the posterior superior alveolar
artery and the infraorbital artery occurs both extra osseously and intra osseously
in the lateral wall of the sinus. The intraosseous anastomosis is 16-19mm from
the ridge while the extraosseous anastomosis occurs nearly 23-26mm from the
ridge and maybe a source of hemorrhage during flap preparation (Bathla et al,
2018).

The maxillary sinus is innervated by the infraorbital and the anterior, middle and
posterior superior alveolar branches of the maxillary nerve. The posterior superior
alveolar nerve has two to three branches which supply the majority of the sensory
innervation. The middle superior alveolar nerve provides secondary mucosal

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innervation whole the anterior superior alveolar innervates the anterior portion of
the sinus. The anterior ethmoidal branch of the ophthalmic nerve supplies
sensation to the infundibulum whereas the maxillary ostium is supplied by the
greater palatine nerve. The nervus intermedius of the facial nerve gives of the
parasympathetic secretomotor fibers which synapse in the pterygopalatine
ganglion and supply the sinus mucosa through the trigeminal sensory branches
(Iwanaga et al, 2019).

The maxillary sinus undergoes age related changes. Various factors contribute to
the developmental changes of the sinus such as, the eruption of the permanent
dentition, pressure from balls against the orbit wall and traction from facial
muscles on the inferior portion of the maxilla. The primary dentition has no
influence of the growth of the sinus. The sinus measure approximately <4.0mm in
height, <7.0mm in anteroposterior depth and <2.7mm in width at birth. There is
rapid sinus growth between 1-8 years of life. Progressing pneumatization varies
from person to person and determines the extent of age-related changes of the
sinus. The eruption of the third molars between 18-21 years changes the sinus to
its adult size. The mean volume of the sinus at this stage is 12.5 ml with a mean
height of 25.33mm, length of 27.96mm and a width of 19.57mm. In edentulous or
partially edentulous cases the maxillary sinus volume is significantly less as
compared to in dentate cases. Collapse of the maxillary bone with age is indicated
by a negative correlation between age of the person and the distance to meatus,
sinus volume and mediolateral dimensions (Iwanaga et al, 2019).

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Figure 3. 2: Development and pneumatization of the maxillary sinus
(Göçmen et al, 2017)

3.1.1 Indications and contraindications of maxillary sinus augmentation

The sinus floor elevation procedure is indicated in certain situations as listed

below (Adel Helmy, 2017, Bathla et al, 2018 and Göçmen et al, 2017):

• Atrophy of the posterior maxillary alveolus.

• Posterior maxillary vertical residual bone height of <10mm.
• Absence of all maxillary premolars and molars.

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Various local and systemic conditions and disorders contraindicate sinus
elevation procedures as listed below:

• A patient history of acute sinusitis where the cause has not been
eliminated.
• Acute active sinus infection with purulent exudate.
• Presence of large cysts or neoplasms in the sinus.
• Diabetes mellitus which is uncontrolled.
• Severe osteoporosis.
• Heavy smokers as they have thin mucosal lining that is prone to
perforation.
• Alcoholics.
• History of sinus surgery including Caldwell-Luc procedures or Le fort 1
osteotomy.
• Psychosis.
• Severe allergic rhinitis.
• History of radiotherapy to the maxilla.
• History of chemotherapy.
• Presence of maxillary sinus septa.

3.2 Different techniques for maxillary sinus elevation

Dental implants have been widely used in oral rehabilitation with over 95%
success rate in either partial, complete or single edentulism. However, due to
several complications implant placement is often compromised in the posterior
maxillary region. The complications may be either physiological or anatomical
including pneumatization of the maxillary sinus, post-extraction alveolar ridge
atrophy or residual alveolar bone of poor quality. Hence, it becomes mandatory
to perform vertical alveolar ridge augmentation either before or in combination
with placement of implants (Sindel et al, 2019).

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A well-known, predictable and largely required procedure called ‘maxillary sinus
augmentation’ becomes necessary for increasing the height of the residual
alveolar bone by means of elevating the Schneiderian membrane. In 1976, Tatum
introduced the surgical technique and Boyne in 1980. Over the years various
techniques or approaches have been extensively studied. To achieve access to
the Schneiderian membrane, there is either direct lateral approach or indirect
through trans-crestal osteotomy. Till date both approaches have been modified
extensively and all have proved to be beneficial. However, these approaches
carry several drawbacks or result in complications which may affect patient’s
quality of life by requiring additional surgery, extensive recovery time,
hospitalization. More-over the survival rate of the implants and the overall success
rate of the reconstruction procedure may be compromised (Sindel et al, 2019).

The type of maxillary sinus augmentation technique to be used purely depends

on the surgeon and the patient’s anatomy. Among the patient’s anatomical factors
residual bone height and amount of lift required are considered before finalizing
the technique. For maxillary sinus elevation there are two approaches: Direct and
indirect approach. Direct approach is called the ‘lateral window technique’, while
indirect approach can be- minimally invasive trans-alveolar sinus approach, antral
membrane balloon elevation, osteotome sinus floor elevation, bone added sinus
floor elevation (Bathla et al, 2019). The direct sinus augmentation technique
comprises of direct visualization of the Schneiderian membrane and manipulation
while indirect sinus augmentation technique comprises of indirect manipulation of
the Schneiderian membrane (Balaji, 2013).

In 1987, a classification was developed by Misch for the treatment of edentulous

posterior maxilla and was based on residual bone height or bone available below
the antrum. The classification has 4 categories SA-1-SA-4 (figure 3.1). The
categories are explained in a tabulated form (table 3.1) (Kumar and Anand, 2015).

26
Table 3. 1: Classification of maxillary sinus (Kumar and Anand, 2015)

Treatment Description
category

SA-1 It has adequate vertical bone for implants, that is 12mm. No

manipulation of sinus is required.

SA-2 It has 0-2mm less than the ideal height of bone and may require
surgical correction.

SA-3 It has just 5-10mm of bone below sinus. Lateral wall approach and
sinus graft.

SA-4 It has less than 5mm of bone below sinus. Lateral wall approach
and sinus graft.

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Figure 3. 3: Classification of maxillary sinus based on residual bone height
(Kumar and Anand, 2015)

3.2.1 Indirect sinus augmentation approach

It is also known as internal approach or crestal approach. It involves elevation of

the bony floor of the sinus in-addition to Schneiderian membrane indirectly
through the alveolar crest with no preparation on the lateral wall of the sinus. This
approach aids in up-to 5mm of elevation of the sinus floor without any perforation.
More-over, indirect sinus lifting can also be performed via trans-crestal approach
in situations with 5-6mm residual bone height. This approach is more
conservation than conventional lateral approach. Post-operative morbidity and
operating time may also be reduced with this approach. It was introduced in 1986
by Tatum however, the approach has gone through several modifications to
negate the complications of this approach and enhance the outcomes with
respect to success rate and feasibility. The modifications rely on certain medical
devices and specific instruments which are only applicable for specific techniques.

28
Even though the techniques have shown remarkable success rates, but evidence
is lacking to support the claim hence, long-term prospective clinical trial is
suggested (figure 3.1) (Sindel et al, 2019).

Osteotome-mediated sinus floor elevation (OSFE), is an indirect technique which

consists of socket former size of an implant which has been selected, the site is
prepared followed by hand tapped in vertical direction to cause green-stick
fracture of the sinus floor. To support the floor of the maxillary sinus implants are
placed later. Summers in 1994, modified the OSFE technique with the
incorporation of conical osteotomes set of varying diameters which could be used
for both implant site preparation and sinus floor elevation. The modified version
resulted in enhanced primary stability of dental implants and aided in increasing
bone density (Sindel et al, 2019).

Bone added osteotome-mediated sinus floor elevation (BAOSFE), is also known

as “Summers technique”. It is OSFE technique with addition of bone graft material.
The graft material is used to act as a hydraulic plug when the osteotome is used
to elevate the sinus in an upward direction. Following implant placement aids in
elevation of the sinus membrane with the help of their apical end via tenting. Graft
materials of different types can be used in this technique (allograft, autograft,
alloplast, xenograft). Literature shows grafts to be beneficial as it maintains the
volume of the sinus membrane however, some studies have reported desirable
results (reduced risk of infections) without the use of grafting material (Sindel et
al, 2019).

29
Figure 3. 4: Crestal approach for maxillary sinus augmentation (Kumar and
Anand, 2016)

BAOSFE was further modified to minimally invasive antral membrane balloon

elevation technique (MIAMBE). This method involved insertion of specifically
designed balloon into the osteotomy site on the alveolar crest, followed by
insufflation with the help of a catheter and saline solution to detach the sinus
membrane. It is indicated to be used in scenarios with alveolar crest 3mm or less
to provide gains in height of approximately 10mm. It has been associated with
limited intra-operative complications (Sindel et al, 2019). Chen et al (2005),
introduced hydrostatic sinus lift technique, involving hydraulic pressure induced
elevation of the Schneiderian membrane. When the initial drill has been done, a
pump is connected to the drill which produces high hydraulic pressure, the sinus
is broke with the help of the pressure and the membrane is lifted. It has been
reported in the literature that this technique reduces the risk of sinus membrane
perforation, and post-operative complications (Sindel et al, 2019).

3.2.2 Direct sinus augmentation approach

It was first demonstrated by Tatum, and this approach is performed with direct
visualization of the sinus membrane. To start with, mid-crestal or palatally
positioned incision is made along the length of the alveolar crest. Two releasing
incision are then made anteriorly and posteriorly. The size of the incision dictates
the adequate visualization and exposure aspect of the surgery. The incision
should extend at-least one tooth beyond the planned side. A full thickness
mucoperiosteal flap is then elevated, this should be done carefully to avoid
exposure of the grafting area in case of wound dehiscence. Much emphasis has
been placed on the size of incision in the literature as it directly affects the
placement of implant, augmentation stage, size of the osteotomy or overall
manipulation during surgery (Gocmen and Ozkan, 2017).
30
Pre-operative examination is of utmost importance in performing direct approach
as the sinus volume is gauged radiographically which aids in determining the
supero-inferior and antero-posterior borders of the lateral window. The shape of
the osteotomy window can be oval or rectangular and size 10x20mm however,
depending on the size of the planned region that requires augmentation the size
of the window can be decreased or increased. It has been recommended that the
inferior border of the lateral window should be 2-5mm superior to the floor of the
sinus to negate sinus membrane rupture and difficulty during in-fracturing. The
point of sinus curette extension at the mesial extent determines the anterior border
of the window while the most posterior planned implant location determines the
distal border (Gocmen and Ozkan, 2017).

The osteotomy is done with a round bur and the outline is made of the lateral
window followed by continuation by connecting the holes. To avoid perforation of
the membrane during elevation, the sharp edges and corners are rounded off.
The elevation can be done either with the help of broad-based freer or curettes,
only when the membrane starts to detach from the corners and edges (figure 3.2).
The detachment should be carried out slowly and bone contact should never be
compromised. It should be assured that the membrane is separated from bone
prior to pushing it in an upward direction, application of excessive pressure during
this step should be avoided. This procedure is performed till desired height is
achieved. Common error made during the procedure is not to extend the medial
side of the sinus which eventually leads to sinus perforation, while placing bone
graft due to the pressure applied during insertion (Gocmen and Ozkan, 2017).

Lateral window technique can be either one-stage protocol or two-stage protocol.

One-stage protocol is performed when there is adequate bone to aid in primary
implant stability (about 5mm in height). However, during this procedure tip of the
implant drill can eventually harm the membrane hence it should be performed
carefully. Two-stage protocol involves placement of graft material into the drilled
hole and then followed up after 6 months. The bony floor space is filled with
particulated bone graft, and they should not be over-packed. Following placement

31
of bone, the mucoperiosteal flap is re-positioned to achieve primary closure
(Gocmen and Ozkan, 2017).

A multi-center trial was conducted by Felice et al (2014) to evaluated one-stage

and two-stage technique and determine which one is preferable for sinus
augmentation with residual bone height of 1-3mm using lateral window technique.
Patients requiring implant supported fixed prosthesis were included in the trial.
The follow-up period was of one year which was post loading. The authors
reported no statistically significant difference between the two protocols as both
achieved their planned goals. Complications were also similar between the
groups however only one implant failed in this trial.

With time, various techniques have been introduced to perform lateral sinus wall
osteotomy. Different types of burs or instruments are used to avoid tearing of the
sinus mucosa. Traditionally, carbide or diamond burs are used for access
preparation however, to prevent perforation a diamond studded concave bur is
used. More-over, piezo-surgery which is an ultrasonic method has also been
recommended due to its selective osteotomy with membrane preservation. Even
though, there has been development in this field, the sinus membrane still is
extremely thin and fine, hence it can rupture with ease if treated roughly. Thereby,
it has been advised to be gentle during osteotomy and lifting (Gocmen and Ozkan,
2017).

Figure 3. 5: Lateral window technique for maxillary sinus augmentation

(Kumar and Anand, 2015).

32
 3.2.3 Grafting materials used in maxillary sinus augmentation

Several materials have been used for grafting in maxillary sinus augmentation to
achieve desired bone height. Grafting materials can be categorized according to
source: xenograft, allograft, alloplast and autograft. They can be used alone or in
combination. Healing with bone grafts takes place through three different
mechanisms: osteoinduction, osteoconduction or osteogenesis. Osteogenesis is
known as the ability to produce new bone whereas osteoinduction is the process
of stimulation osteogenesis. Lastly, ability of a material to support bone growth is
known as osteoconduction. Grafting materials usually use the osteoconductivity
mechanism to stabilize the components during the healing phase in-addition to
providing biomechanical support and establishing scaffold for new bone formation
(Gocmen and Ozkan, 2017).

Autografts are considered to be gold standard for maxillary sinus augmentation.

It has osteoconductive, osteogenic and osteoinductive features. Moreover, it is
biocompatible. However, the disadvantage of autografts is the donor site
morbidity. Autografts have a higher rate of resorption. They can be harvested from
multiple sites; the site is solely dependent on the amount of bone required.
Autografts can be particulated either by bone grinder or bone mill, this way the
material can be spread in the bony space. This way vascular infiltration, bone
matrix formation, angiogenesis is facilitated, and in-turn healing capacity is
improved. Particulated bone chips can be used in combination with blood or
platelet rich fibrin (PRF) which results in a better organized bone matrix.
Complication of autografts are generally donor site specific such as infection,
dental injury, pain, sensory disturbances, gait disturbance, and hernia (Gocmen
and Ozkan, 2017).
Allogenic grafts can also be used since they are biocompatible however they also
have a high resorption rate and possess risk of disease transmission. They
originate from humans and are retrieved from tissue banks. Demineralized form

33
is preferred since it offers osteoconductive feature and bone morphogenetic
protein ingredient (BMP) while mineralized forms are discouraged due to slow
bone turnover rate. Alloplastic graft materials are made from hydroxyapatite,
calcium phosphates, and bioactive glass. They also have a high resorption rate,
but bio-glass resorbs slowly. Hence, timing of implant placement is crucial and
highly dependent on the properties of the graft used (Gocmen and Ozkan, 2017).
Xenografts are basically obtained from different species. Deproteinized bovine
bone is mostly used in maxillary sinus augmentation due to its osteoconductive
feature. It can be used alone or in combination. Grafts have different healing
period extending from 4-10 months. Resorption rate of grafting materials is an
important parameter in sinus augmentation procedure due to the fact that if the
material resorbs sooner than volume of the graft will reduce. Hence implants can
be placed earlier in such cases as compared to non-resorbable materials used
(Gocmen and Ozkan, 2017).
It has been said that autografts and xenografts generate the best and predictable
results in sinus augmentation procedure. Awareness of the properties of grafting
material is of utmost important in actually obtaining optimum success and
outcome of the grafting procedure. The grafting materials placed in the posterior
maxillary region and sinus membrane will have a rich bloody supply since the
region itself is rich in vasculature. This regional advantage also enhances the
osteoblastic activity of the augmented site. The importance of the membrane in
the sinus-lift procedure should not be underestimated. It is reported that the
Schneiderian membrane has the feature of inducing and increasing
osteoprogenitor cells. Various techniques are used to create a bony space for
implant placement while maintaining the membrane intact to allow for graft
nutrition and a barrier from the maxillary sinus cavity used Multiple factors play a
role in obtaining successful outcomes such as surgeons experience and method
of augmentation play a major role. Selecting the most proper technique for every
individual case and applying sound surgical techniques at the appropriate surgical
site are mandatory to obtain long-term successful outcomes (Gocmen and Ozkan,
2017).

34
3.3 ‘Rotary instrumentation’ or handpieces for maxillary sinus elevation

Maxillary sinus pneumatization in addition with loss of teeth leads to reduced bone
height and volume. Poor bone quality and diminished bone dimensions
complicate the insertion and housing of dental implants resulting in unsuccessful
treatment outcomes. To improve bone conditions for implant usage, maxillary
sinus augmentation may be necessary. This technique involves the use of rotary
instruments or piezo-electric devices to create a window in the lateral osseous
wall below the zygoma to access the Schneiderian membrane (Garg et al, 2019).
Rotary instruments incorporating diamond or carbide burs are used to create the
access window through which hand instruments are inserted to elevate the sinus
membrane from the boney floor and construct lateral or medial walls to create an
area for accommodating the graft material. Figure 1 shows a kit that has been
developed to include all necessary instruments for sinus augmentation through
lateral approach (Garg et al, 2019).

Figure 3. 6: Shows the lateral wall sinus kit (Garg et al, 2019)

35
During the access of the lateral wall by rotary instruments, there is a risk of
damage to the underlying sinus membrane. Depth rings for rotary carbide or
diamond burs are available to reduce the risk of such complications. For the
creation of a lateral window, lateral access stoppers ranging from 0.5mm to
3.0mm are available which help the clinician in keeping check of the amount of
instrument that has been inserted and how much more depth penetration can
occur, thus minimizing the risk of membrane tear (Garg et al, 2019).

Figure 3. 7: Shows LA stoppers ranging from 0.5mm to 3.0mm demonstrated on

rotary bur (Garg et al, 2019)

For creation of the lateral window rotary carbides or diamonds are used. The
diamond has an 8.0mm diameter rounded or flat end and has great precision while
cutting, whereas the carbide is available in 6.0mm and 8.0mm diameters and have
aggressive bone cutting qualities and are indicated when the sinus wall is thick
and dense. When the lateral osseous wall is thick, the carbide is recommended
for window creation, cutting it till the wall thickness has decreased significantly
from where on the diamond is used. This technique reduces time required to
create the window. This is followed by widening of the window base after gaining
36
access into the sinus, using ‘widener’ burs which have smooth wide heads and a
narrow diamond covered shaft. The smooth head is used to lift the sinus
membrane for preventing membrane damage while the diamond covered shaft is
used to enlarge the window (Garg et al, 2019).

When the completed lateral window is to be replaced by an osseous window

following sinus augmentation, ‘island’ burs are used which are serrated end
cylinder or diamond coated cylinder of an 8.0mm depth. They are paired with LA
stoppers to control depth penetration (Garg et al, 2019).

Figure 3. 8: Shows rotary instruments which are used with handpieces (Garg et
al, 2019)

Following the initial membrane elevation around the osseous window, hand
instruments are used to further elevate the membrane from the boney sinus floor
and the medial sinus wall. The hand instruments used for this procedure are
labelled TOLA II 1 to 4 of which TOLA II 1, 2 and 3 are curved end curettes that
are utilized to lift the sinus membrane from the floor. One end of the TOLA II 1 is
shaped and works the same as the widener. Finally, the TOLA II 4 is used to carry
graft material under the elevated sinus membrane and the condenser end
compacts the material into the grafted area (Garg et al, 2019).

37
 Figure 3. 9: shows the TOLA II hand instruments (Garg et al, 2019)

Rotary instruments have been classically used for creation of osseous windows
for sinus augmentation. But with increased incidents of sinus membrane
perforation, newer technology has been innovated which minimizes sinus
membrane perforation risk. The following table outlines the advantages and
disadvantages of rotary instruments (Nicolucci, 2011):
Table 3. 2: Advantages and disadvantages of Rotary instrumentation
(Nicolucci, 2011)
ADVANTAGES OF ROTARY DISADVANTAGES OF ROTARY
INSTRUMENTS INSTRUMENTS
Faster speed as compared to PED Greater rate of sinus membrane damage
devices and perforation as compared to PEDs
Greater patient sensation to vibrations Cannot differentiate between mineralized
and non-mineralized tissue
Cheaper as compared to PED devices Reduced visibility as greater instrument
diameter
Short operating time reduces post-op Short life of rotary burs
discomfort for the patient
Short operating time reduces chances of Reduced accuracy compared to PED
infection devices

38
 3.3.1 Intra-operative and post-operative complications of rotary
instrumentation and prevention

Despite being described as a predictable procedure, maxillary sinus augmentation using

rotary instruments can give rise to several intra-operative and post-operative
complications that can jeopardize treatment results. They are described as follows:

3.3.1.1 Intra-operative complications:

Surgical complications occurring during the time period of the procedure are classified as
intra-operative complications. These difficulties can arise from errors by the clinician,
maneuvers and technique, incorrect diagnosis and poor knowledge of the anatomy. The
common intra-operative complications as a consequence of instrumentation are
perforation of the sinus membrane and excessive bleeding (Sindel et al, 2018).

Sinus membrane perforation is the most common intra-operative complication using hand
instruments. The reported incidence ranges from 20-40% of cases. The complication can
occur at various stages of the sinus augmentation such as during the preparation of the
antrostomy, during removal or turning over the boney window, while elevating the sinus
membrane and during the placement of the graft material. Computed Tomography (CT)
can be used to assess the anatomy of the sinus for the determination of the location of
the sinus membrane thus preventing its perforation. In addition, use of piezoelectric
surgery greatly reduces the chances of sinus membrane perforation. Use of diamond
burs and elevating the sinus membrane from lateral to medial side while keeping the
instrument in contact with bone can also prevent membrane damage (Sindel et al, 2018).

Despite performing ideal surgical maneuvers, sinus perforation may be unavoidable.

Management of the perforation begins with exacting the size of the tear, by gently lifting
the surrounding membrane to avoid further tearing and reduce tension. Perforations of
less than 1mm are considered minor and usually self-heal. For perforation less than 5mm
in size, the use of collagen tapes, bio absorbable membranes, fibrin glues or suturing is
sufficient for closure and implant placement. Major perforations, larger than 5mm in size
may need lamellar bone plates, bio absorbable membranes or suturing alone or in

39
addition with fibrin glue. No matter the size of the perforation, the stability of the perforated
area to contain graft material should have no doubts (Sindel et al, 2018).

Management of larger perforation can be challenging. Several repair methods have been
suggested based on the use of local flaps, collagen membranes and autogenous bone
blocks. The Loma Linda pouch technique was introduced by Proussaefs et al (2003). This
method involves the use of slow resorbing collagen membrane to cover all internal bony
walls, thus mimicking the natural sinus membrane, and fixating it with an external tack by
folding the membrane on the lateral wall. There is a risk of blood supply impairment from
sinus wall due to pouch formation surrounding the graft, thus hindering its maturation.
Another technique called the intra-sinusal locking technique was introduced by Sindel et
al which involves simultaneous implant placement despite the presence of a large
perforation, thus reducing number of surgical interventions and complications.
Autogenous bone ring blocks from the mandibular symphysis are placed in the maxillary
sinus floor and steadied by dental implant installation. A 90% implant survival rate with
no post-operative complication was reported, thus proving the techniques success
(Sindel et al, 2018).

Severe bleeding from damage to the alveolar antral artery (is an intraosseous
anastomosis between the infraorbital artery and the posterior superior alveolar artery) is
the second most common intra-operative complication during maxillary sinus lift.
Excessive bleeding may also occur due to damage to the posterior lateral nasal artery
and the extraosseous anastomosis of the infraorbital and the posterior superior alveolar
artery. These can cause additional difficulties such as limiting blood supply, membrane
perforation and graft displacement thus further complicating the situation (Sindel et al,
2018).

Use of CBCT to analyze the vascular structures prior to the procedure can help reduce
the chances of damaging any vessels. Use of piezoelectric devices and diamond burs
while using rotary instruments for the creation of the osseous window will decrease risk
of bleeding. If the vessel has been damaged, bleeding can be controlled by applying
pressure to the bleeding point, using local vasoconstrictors, using electrocautery to
reduce bleeding, crushing bone around the damaged vessel or suturing the vessel all
together (Sindel et al, 2018).

40
 3.3.1.2 Post-operative complications:

Membrane perforation and failure to use aseptic technique during maxillary sinus
augmentation can predispose to graft infections. Graft infections can cause severe pain,
tenderness, facial swelling, fever, abscess, suppuration, fistulation and loss of graft
particles through the fistulous tract known as the popcorn sign. Urgent treatment is
required as this is a fast spreading infection, possibly resulting in orbital cellulitis,
infraorbital abscess and can even cause brain abscesses. Treatment modalities included
administering systemic antibiotics, removal of partial or total graft material, irrigation and
drainage. A dome phenomenon was recently described in which dense, hard, solid tissue
is maintained in the superior most aspect of the graft after a graft infection. Partial removal
of the infected graft reported successful outcomes indicating towards the schneiderian
membranes regenerative potential. Removal of all the infected graft material can enable
bone growth in the area (Sindel et al, 2018).

3.4 ‘Piezo-electric surgery’ for maxillary sinus elevation

Over the years, many surgical techniques have been introduced for maxillary
sinus augmentation however, the possibility of perforating the Schneiderian
membrane still persists. Traditionally, hand and rotary instruments have been
used for osseous surgery with copious irrigation to compensate for the heat
generated by the instruments. Moreover, considerable pressure is exerted in
osseous surgery with rotary instrumentation with exception in case of brittle bone
or fracture. To counter the drawbacks of rotary instrumentation a novel surgical
technique was introduced based on ultrasonic micro-vibrations for precise and
selective cut on the bone and avoiding any damage on the adjacent soft tissues.

41
The new method introduced in the field of dentistry was termed as piezo surgery.
It was invented by Vercelloti in 1988. Jacque and Pierre discovered the basic
principle of piezoelectricity being utilized for bone cutting was primarily based on
ultrasonic micro-vibrations. In 1999, Thomas Vercelloti invented piezoelectric
bone surgery and published in 2000. In 2003, Vercelloti discovered the ideal
frequency method for oral and maxillofacial surgeries and periodontal (Thomas et
al, 2017).

‘Piezoelectric bone window osteotomy’ involved cutting of the mineralized tissue

without inflicting damage to the surrounding soft tissues, and elevation of the
Schneiderian membrane by using piezoelectric elevators without causing
perforations. The elevation was not only done by piezoelectric elevator’s, but the
force of a physiologic solution also aided in the process subjected to piezoelectric
cavitation. Piezo surgery simplified the maxillary sinus augmentation procedure
in-addition to avoidance of perforation of the Schneiderian membrane (Vercelloti
et al,2001).

Piezo surgery is a relatively new technique which utilizes ultrasonic vibrations for
osteotomy and osteoplasty. It comprises of an ultrasound machine with
modulated frequency and a controlled tip vibration range (Seshan et al, 2009).
The insert tip, which is the instrument head sets out controlled ultrasonic
vibrations resulting in precise piezoelectric bone cutting. The amplitude of the
insert tip is very small (60 to 210 µm side-to-side, 20 to 60 µm vertically) producing
a micrometric cut. The advantage of this technique is that its selective, due to the
frequency used only bone is cut not soft tissues. Use of piezoelectric device also
provides a surgical field free of blood, which is due to the “cavitation effect” (mainly
because of the irrigation and ultrasonic effects of the physiologic solution). The
cavitation effect is due to depressions created in the irrigation solution produce
bubbles of saturated vapor that result in the formation of smaller bubbles, now
this aerosol formed by the irrigation solution has an enhanced capacity to remove
debris and provide a clean surgical field (Garcia et al, 2007).

42
Piezo surgery not only provides a surgical field free of blood but also aids in
maintenance of integrity of the adjacent soft tissues (periosteum and
nerve/vascular bundles) in-addition to providing good visibility in the surgical field.
The precision of the cuts is achieved mainly due to the design of the tips and the
vibration rate which the surgeon has full control over. Moreover, risk of
complications with respect to damage to the adjacent soft tissues including blood
vessels and nerves is significantly reduced. Alveolar distraction osteogenesis is a
technique which is associated with some complications and requires some
surgical skill. The most difficult part of this technique is osteotomy due to the fact
that lingual periosteum’s integrity needs to be maintained which will eventually
maintain the vascularity of the transport segment. The procedure becomes
complicated due to endo-osseous implant placement in close proximity to
important structures (inferior dental never or Schneiderian membrane) to gain
alveolar ridge height. In such scenarios the bone cut to be precise becomes of
utmost importance for the procedure to be carried out successfully devoid of any
complication hence piezo surgery is suggested to be ideal for this purpose
because the insert tip only cuts bone (Garcia et al, 2007).
Piezo surgery may result in tissue lesion if used inappropriately, for instance
application of excessive pressure with the insert tip or if the tip breaks or is
overheated. However, risk of this complication is low when compared to rotary
instrumentation. Moreover, risk of marginal osteonecrosis is also lower with piezo
surgery. There have no studies on adverse effects of piezoelectric osteotomy with
respect to impaired bone flow or thrombogenesis as per author’s knowledge.
Trials of piezo surgery in animals have indicated that ultrasonic frequencies of
20KHz can result in intra-vascular clots, but the incidence of this more likely to
take place in the mandible which already has poor vascularization. It has been
suggested that further clinical trials need to be conducted to further evaluate the
efficacy of this technique even though promising results have been displayed to
adopt it in routine clinical practice (Baldi et al, 2011).
As discussed earlier that the most common complication affiliated with sinus
augmentation techniques is Schneiderian membrane perforation, but with the

43
introduction of piezoelectric technique this complication has been significantly
reduced from 30% of rotary instrumentation to 7% as reported by Wallace et al.
Piezoelectric ultrasonic vibration (25-30 kHz) aids in precise cutting of only
mineralized structures and the cavitation effect contributes in atraumatic sinus
membrane elevation (figure 3.6). The piezo surgery causes less discomfort to the
patient because of the movement of piezo surgery knife which is small and the
precise cutting. Another advantage of this technique is that the macro-vibration’s
absence enables the instrument handling more manageable and allows greater
intra-operative control for the surgeon even in situations with anatomical
difficulties (Baldi et al, 2011).

Figure 3. 10: Piezoelectric devices can contact the Schneiderian membrane

(left image), Membrane elevation obtained by piezo surgery (right image)
(Baldi et al, 2011)

Piezosurgery is considered to be a less invasive procedure. It aids in providing

primary implant stability by improving bone density (Baldi et al, 2011). Moreover,
piezo surgery is easy to manage in situations where gain in direct visibility is
required during osteotomy, while on the other hand it becomes difficult to avoid
blinding with use of burs and chisels. Finally, some suggest the performance of
para-midline osteotomies because in the palatal midline the bone is thick, and the
mucosa is thin, and osteotomies are at risk. With this safe tool, it is possible to
perform midline osteotomies with minimal risk of palatal soft tissue damage.

44
Postoperatively, no complications were noted. Teeth vitality and periodontal
health were maintained in our preliminary experience (Robiony et al, 2004).
The limitations of piezo surgery are minimal, surgical operation time is slightly
longer when piezo surgery is performed. It also requires a short learning curve; it
is important to gain adequate dexterity because it is decisively different from that
used for conventional tools. To overcome any problems during surgery, instead
of increasing pressure on the handpiece, as in traditional techniques, it is
necessary to find the correct pressure to achieve the desired result. With
piezoelectric surgery, increasing the working pressure above a certain limit
impedes the vibrations of the insert, the energy is transformed into heat, and
tissue damage therefore can occur (Robiony et al, 2004).

3.5 Clinical studies on rotary instrumentation versus piezo-electric surgery for

lateral maxillary sinus augmentation

Stacchi et al (2013) conducted a randomized controlled trial (RCT) to evaluate the

intra-operative prevalence during maxillary sinus elevation procedure. The
technique opted for was lateral approach using piezo-electric device with two
different surgical techniques. Total of 72 patients were included in the trial. Group
A (36 patients) in which antrostomies were randomly performed by outlining a
window using piezo-electric device. Group B (36 patients) in which prior to
outlining the window, the lateral wall of the sinus was eroded with ultrasonic
instrument. The results demonstrated that Group B had no perforations (p<0.05)
while four perforations were observed in Group A (11.1%) (two occurred during
elevation with hand instruments). Vascular lacerations were not reported in either
of the groups. Group A had shorter surgical time (9.2±3.7 minutes) while Group B
had surgical time of (13.3±2.4 minutes) p<0.05). No patients dropped out during
the trial. Conclusion made was that ultrasonic erosion of the lateral wall seems to
be a viable treatment option than piezo-electric outlining of the bony window alone
in preventing membrane perforations during maxillary sinus augmentation
procedure.

45
Rickert et al (2011) conducted a RCT comprising of 36 patients to determine the
clinical efficacy of conventional rotary instruments versus piezo-electric device in
maxillary sinus floor elevation surgery, more-over the significance of resorbable
membrane was also assessed whether it reduces resorption of an augmented
site. Mean age of patients was (59.2±10.7 years), range 38-76 years). Patients
requiring bilateral sinus elevation/ augmentation were included in the trial. It was
a parallel split mouth design RCT. Patients and surgical sites were randomly
allocated into groups, conventional rotating instruments (control group) while
piezo surgery (test group). Similarly, collagen membrane placement was also
carried out randomly, some sites were covered with the membrane while some
were not. Following a healing period of 3-4 months, implants were placed. Results
showed no statistically significant difference between the groups with respect to
wound healing and complications (perforation of the Schneiderian membrane)
(p=0.458, p=1.0). with respect to surgical time, difference was observed however,
it was clinically insignificant, control group (11±2.4 minutes), test group (15.1±2.9
minutes) (p<0.001). Collagen membrane also showed no statistically significant
difference between the groups (p=0.062). Total of 193 implants were placed with
primary stability and post loading survival rate was 100% after one year.
Conclusion made was that piezo surgery displayed no advantages over rotary
instruments and placement of resorbable membrane did not reduce resorption at
the augmented sites either.

A comparative study was conducted to assess the clinical efficacy of rotary

technique and ultrasound in direct maxillary sinus lift. The parameters that were
assessed in this study were rupture of sinus membrane, survival of implants
placed after sinus augmentation and lastly, gain in bone height post-operatively
and 12 months after placement of the prosthesis. A total of 45 patients were
included in this trial. In rotary instrumentation hand piece and ostectomy drills
were used while specifics tips were used ultrasound. Gain in bone height was
analyzed using post-operative panoramic X-rays. Total of 57 direct elevations
were carried out. 32 elevations were done using rotary instrumentation technique
while 25 with ultrasound. 7% of perforation of membrane was observed in rotary
46
instrumentation technique while 1.7% in ultrasonic. Membrane integrity was
preserved in 91.2% of the cases. Total of 100 implants were placed, after the one-
year follow-up period 5 failed in the rotary technique group while one failed in
ultrasonic group. Gain in bone was observed in bone groups however, ultrasonic
group displayed better results with 6.7mm gain while rotary technique group had
5.9mm gain. It was concluded that ultrasonic technique seems to perform better
than conventional rotary technique based on the results of the trial (Diago et al,
2012)

Barone et al (2008) conducted a comparative study analyzing piezoelectric device

versus rotary instruments in maxillary sinus floor elevation. The clinical efficacy of
the two approaches was assessed in this RCT. 13 patients were included in this
trial requiring bilateral maxillary sinus augmentation for implant supported
prosthesis. This trial was a within patient control study. Osteotomy on one side of
the maxilla was carried out using piezoelectric device (test group) while on the
other side rotary instruments were used (control group). The parameters
assessed in this trial were surgical time, complications, bone window length and
height and bone thickness. The results show that the mean height and length is
similar in both groups. However, difference was observed in osteotomy area
which was wider in control group (151.2±20.4mm) in-comparison to test group
(137±24.2mm). Surgical time for test group was (11.5±3.8 minutes) while for
control group (10.2±2.4 minutes). Moreover, membrane perforations were higher
in test group (30%) while in control group (23%). On the contrary the differences
observed between the groups were of no statistical difference. Both approaches
did not show any difference with respect to the clinical parameters being assessed
in maxillary sinus elevation procedure.

Baldi et al (2011) conducted a trial to determine the performance of piezo surgery

versus osteotomes in maxillary sinus augmentation. 36 implants were placed in
25 patients. Patients with atrophic maxilla requiring implant supported prosthesis
were included in the study. Osteotomes and burs or piezo surgery was performed
to elevate the sinus membrane with a crestal approach. Residual bone of less

47
than or equal to 7.5mm was considered to be included in the trial. Radiographs
were taken prior to the procedure and at one-year follow-up period. Results
showed that mean residual bone height was 5.61mm while gain of sinus elevation
was 6.78mm at one-year post-surgery. Only 23 patients completed the study, two
patients dropped out. One implant failed while the rest of the 33 implants were
stable even after 12-months (survival rate 97%). The authors also evaluated the
difference between type of implants placed and found that tapered implants
yielded higher bone height than cylindrical (P<0.05). Authors concluded that no
statistically significant difference was found in bone level using osteotomes or
piezo surgery however, piezo surgery did result in less discomfort to the patient
and it was a convenient technique to be performed by the surgeon.
Vercelloti et al (2001) conducted a trial to assess the clinical efficacy of piezo
surgery in maxillary sinus augmentation. Total of 15 patients were included in the
study. 21 piezoelectric bone window osteotomy and piezoelectric sinus
membrane elevations were performed using Mectron piezo surgery system.
Results showed that only one perforation was reported during the osteotomy
procedure resulting in 95% success rate. The average length of the window was
14 mm; its height was 6 mm, and its thickness was 1.4 mm. The average time
necessary for the piezoelectric bony window osteotomy was approximately 3
minutes, while the piezoelectric sinus membrane elevation required
approximately 5 minutes.

3.6 Aims and objectives

3.6.1 Aims

To review the clinical performance of piezoelectric surgery compared to rotary

instrumentation for lateral maxillary sinus elevation and grafting. Moreover,
analyzing the intra-operative complication, post-operative complication and
implant stability.

48
 3.6.2 Objectives

1. To review the clinical performance of piezoelectric surgery vs rotary

instrumentation for lateral maxillary sinus elevation and grafting based on
literature retrieved through electronic database.
2. To identify clinical systematic reviews and meta-analysis reporting the
comparison between piezoelectric and rotary hand instrumentation for lateral
maxillary sinus elevation in terms of membrane perforation rate.
3. To identify clinical systematic reviews and meta-analysis comparing the intra-
operative complication; time between the two interventions and the
postoperative complication; sinus / wound infection between piezoelectric and
rotary hand instrumentation.
4. To identify clinical systematic reviews and meta-analysis comparing the post-
operative implant stability after piezoelectric or rotatory instrumentation
procedures.
5. Appraisal of the relevant articles to assess the quality (Critical appraisal).
6. Conclude with proposing the ideal treatment modality in relation to intra and
post-operative complication (contributing to evidence-based dentistry).

4 Methodology

4.1 Study design

This dissertation is a review of systematic reviews and meta-analysis that

will compare the piezoelectric to conventional instrumentation regarding
the lateral sinus lifting and augmentation for implant placement. It will also
analyze the intra-operative complications in-addition to post-operative
complications and implant stability.

49
4.2 Research question

“What is the clinical performance of piezoelectric surgery versus conventional surgery

in lateral maxillary sinus elevation and graft procedures in regard to their intra operative
and post-operative complications?”

To formulate a focused research question, the ‘PICO’ tool has been applied:

Population (P): Requiring lateral maxillary sinus augmentation.

Intervention (I): The use of Piezoelectric surgery for lateral maxillary sinus
augmentation.

Comparison (C): Rotary instrumentation or Traditional handpieces for later maxillary

sinus access, elevation, and grafting

Outcomes (O): Primary outcomes- Intraoperative complication rate: membrane

perforation in percentage, surgical duration in mins (including osteotomy, bony window
opening, sinus elevation)

Secondary outcomes- postoperative implant morbidity rate and implant stability

(measured by torque-implant friction with bone or ISQ -resistance to friction or lateral
movement).

50
4.3 Selection criteria

4.3.1 Inclusion

• Systematic reviews and meta-analysis comparing piezoelectric

with traditional rotatory and hand instrumentation for lateral
maxillary sinus elevation reporting on intra-operative outcomes
and post-operative outcomes such as membrane perforation,
operative time, morbidity rate and implant stability rate.
• Human studies.
• Reviews not involving patients under-taking bisphosphonates.
• Studies in English language only.
• Studies published from 2010-2020 (10-years).

4.3.2 Exclusion

• Studies on trans-alveolar techniques.

• In vitro-studies.
• Any other type of study.
• Systematic reviews involving patients on medications.
• Systematic reviews involving immunocompromised patients.
• History or concurrent sinus pathology.
• Studies with published abstracts only.

51
4.4 Search strategy

Literature search was conducted on a single electronic database: PubMed

(Medline). The search included articles published in the last 10 years
(2010-2020). Focus was on retrieving recent publications and conducting
an analysis on them. To make the search reliable and relevant filters
mentioned in the inclusion and exclusion criteria were applied which aided
in limiting the number of publications and generating only the relevant
studies. Booleans (AND, OR, NOT) were used with the ‘keywords’ to
generate the articles on the database. More-over, reference lists of the
relevant systematic reviews were searched for further relevant studies to
be included in the study.

For the literature search to be relevant to the ‘Research Question’’, certain

keywords were used on search engines example are as follows: “Sinus
augmentation” “Sinus lifting” “Sinus lift” “Maxillary sinus
augmentation” “lateral maxillary sinus augmentation” “Piezoelectric surgery”
“Piezo surgery” “Rotary instrumentation” “Traditional instrumentation”
“Conventional instrumentation” “Hand instrumentation” “Intra-operative
complication” “Membrane perforation” “Schneiderian membrane
perforation” “Surgical duration” “Surgical time” “Implant stability” “Post-
operative complication” “post-operative morbidity rate”.

These keywords were used with Booleans to produce maximum amount of

results; PubMed, detailed in tabulated form in (Table 4.1 and 4.2).

52
Table 4. 1: Literature search strategy on PubMed

Queries in PubMed Query Items

found
((((Sinus augmentation) OR Sinus lift) OR Sinus lifting) OR
Population (P) Maxillary sinus augmentation) OR Lateral maxillary sinus 4038
augmentation OR Lateral maxillary sinus floor augmentation
((Piezoelectric surgery) OR Piezosurgery OR Piezoelectric
Intervention (I) device) OR Electric surgery 60629
((Traditional instrumentation) OR Conventional OR
Comparison (C) Conventional instrumentation OR Conventional rotating 519077
instruments OR Conventional drilling) OR Rotary
instrumentation OR Hand instrumentation)
((((((Intraoperative complication) OR Membrane perforation
OR perforation OR Schneiderian membrane perforation) OR
surgical time) OR surgical duration) OR implant stability) OR 1129194
Outcome (O) postoperative complication) OR postoperative morbidity rate
((((((((Sinus augmentation) OR Sinus lift) OR Sinus lifting)
P AND I AND C AND OR Maxillary sinus augmentation) OR Lateral maxillary sinus
O augmentation OR Lateral maxillary sinus floor augmentation))
AND (((Piezoelectric surgery) OR Piezosurgery) OR Electric
surgery)) AND (((Traditional instrumentation) OR Conventional 20
OR Conventional instrumentation OR Conventional rotating
instruments Or Conventional drilling) OR Hand instrumentation
OR Rotary instrumentation)) AND (((((((Intraoperative
complication) OR Membrane perforation OR perforation OR
schneiderian membrane perforation OR perforation rate) OR
surgical time) OR surgical duration) OR implant stability) OR
postoperative complication) OR postoperative morbidity rate)
P AND I OR C AND P AND I OR C AND O 43608
O

P AND I NOT C AND P AND I NOT C AND O 54

O

53
Table 4. 2: Search details and Mesh terms on PubMed

((((((((("paranasal sinuses"[MeSH Terms] OR ("paranasal"[All Fields] AND "sinuses"[All Fields])) OR

"paranasal sinuses"[All Fields]) OR "sinus"[All Fields]) OR "sinus s"[All Fields]) AND ((((("augment"[All
Fields] OR "augmentation"[All Fields]) OR "augmentations"[All Fields]) OR "augmented"[All Fields])
OR "augmenting"[All Fields]) OR "augments"[All Fields])) OR ((((("paranasal sinuses"[MeSH Terms]
Population OR ("paranasal"[All Fields] AND "sinuses"[All Fields])) OR "paranasal sinuses"[All Fields]) OR
(P) "sinus"[All Fields]) OR "sinus s"[All Fields]) AND (("lifting"[MeSH Terms] OR "lifting"[All Fields]) OR
"lift"[All Fields]))) OR ((((("paranasal sinuses"[MeSH Terms] OR ("paranasal"[All Fields] AND
"sinuses"[All Fields])) OR "paranasal sinuses"[All Fields]) OR "sinus"[All Fields]) OR "sinus s"[All
Fields]) AND (((("lifting"[MeSH Terms] OR "lifting"[All Fields]) OR "lifted"[All Fields]) OR "liftings"[All
Fields]) OR "lifts"[All Fields]))) OR ((("maxillary sinus"[MeSH Terms] OR ("maxillary"[All Fields] AND
"sinus"[All Fields])) OR "maxillary sinus"[All Fields]) AND ((((("augment"[All Fields] OR
"augmentation"[All Fields]) OR "augmentations"[All Fields]) OR "augmented"[All Fields]) OR
"augmenting"[All Fields]) OR "augments"[All Fields]))) OR (((((((((((((((((((("functional laterality"[MeSH
Terms] OR ("functional"[All Fields] AND "laterality"[All Fields])) OR "functional laterality"[All Fields]) OR
"laterality"[All Fields]) OR "lateral"[All Fields]) OR "lateralisation"[All Fields]) OR "laterally"[All Fields])
OR "laterals"[All Fields]) AND (("maxillary sinus"[MeSH Terms] OR ("maxillary"[All Fields] AND
"sinus"[All Fields])) OR "maxillary sinus"[All Fields]) AND ((((("augment"[All Fields] OR
"augmentation"[All Fields]) OR "augmentations"[All Fields]) OR "augmented"[All Fields]) OR
"augmenting"[All Fields]) OR "augments"[All Fields]))) OR (((((((((((((((((((("functional laterality"[MeSH
Terms] OR ("functional"[All Fields] AND "laterality"[All Fields])) OR "functional laterality"[All Fields]) OR
"laterality"[All Fields]) OR "lateral"[All Fields]) OR "lateralisation"[All Fields]) OR "lateralisations"[All
Fields]) OR "lateralise"[All Fields]) OR "lateralised"[All Fields]) OR "lateralises"[All Fields]) OR
"lateralising"[All Fields]) OR "lateralities"[All Fields]) OR "lateralization"[All Fields]) OR
"lateralizations"[All Fields]) OR "lateralize"[All Fields]) OR "lateralized"[All Fields]) OR "lateralizes"[All
Fields]) OR "lateralizing"[All Fields]) OR "laterally"[All Fields]) OR "laterals"[All Fields]) AND (((("sinus
floor augmentation"[MeSH Terms] OR (("sinus"[All Fields] AND "floor"[All Fields]) AND
"augmentation"[All Fields])) OR "sinus floor augmentation"[All Fields]) OR ((("maxillary"[All Fields] AND
"sinus"[All Fields]) AND "floor"[All Fields]) AND "augmentation"[All Fields])) OR "maxillary sinus floor
augmentation"[All Fields]))
((((((("piezoelectric"[All Fields] OR "piezoelectrical"[All Fields]) OR "piezoelectrically"[All Fields]) OR
"piezoelectricity"[All Fields]) OR "piezoelectrics"[All Fields]) AND (((((((((("surgery"[MeSH Subheading]
OR "surgery"[All Fields]) OR "surgical procedures, operative"[MeSH Terms]) OR (("surgical"[All Fields]
AND "procedures"[All Fields]) AND "operative"[All Fields])) OR "operative surgical procedures"[All
Intervention
Fields]) OR "general surgery"[MeSH Terms]) OR ("general"[All Fields] AND "surgery"[All Fields])) OR
(I) "general surgery"[All Fields]) OR "surgery s"[All Fields]) OR "surgerys"[All Fields]) OR "surgeries"[All
Fields])) OR ("piezosurgery"[MeSH Terms] OR "piezosurgery"[All Fields])) OR ((((("piezoelectric"[All
Fields] OR "piezoelectrical"[All Fields]) OR "piezoelectrically"[All Fields]) OR "piezoelectricity"[All
Fields]) OR "piezoelectrics"[All Fields]) AND ((((((("device s"[All Fields] OR "equipment and
supplies"[MeSH Terms]) OR ("equipment"[All Fields] AND "supplies"[All Fields])) OR "equipment and
supplies"[All Fields]) OR "device"[All Fields]) OR "instrumentation"[MeSH Subheading]) OR
"instrumentation"[All Fields]) OR "devices"[All Fields]))) OR (((((("electricity"[MeSH Terms] OR
"electricity"[All Fields]) OR "electric"[All Fields]) OR "electrical"[All Fields]) OR "electrically"[All Fields])
OR "electrics"[All Fields]) AND (((((((((("surgery"[MeSH Subheading] OR "surgery"[All Fields]) OR

54
 "surgical procedures, operative"[MeSH Terms]) OR (("surgical"[All Fields] AND "procedures"[All
Fields]) AND "operative"[All Fields])) OR "operative surgical procedures"[All Fields]) OR "general
surgery"[MeSH Terms]) OR ("general"[All Fields] AND "surgery"[All Fields])) OR "general surgery"[All
Fields]) OR "surgery s"[All Fields]) OR "surgerys"[All Fields]) OR "surgeries"[All Fields]))
(((((((((("tradition"[All Fields] OR "tradition s"[All Fields]) OR "traditional"[All Fields]) OR "traditionals"[All
Fields]) OR "traditions"[All Fields]) AND ((((("instrumentation"[MeSH Subheading] OR
Comparison "instrumentation"[All Fields]) OR "instrumentation s"[All Fields]) OR "instrumentational"[All Fields]) OR
"instrumentations"[All Fields]) OR "instrumention"[All Fields])) OR ("conventional"[All Fields] OR
(C) "conventionals"[All Fields])) OR (("conventional"[All Fields] OR "conventionals"[All Fields]) AND
((((("instrumentation"[MeSH Subheading] OR "instrumentation"[All Fields]) OR "instrumentation s"[All
Fields]) OR "instrumentational"[All Fields]) OR "instrumentations"[All Fields]) OR "instrumention"[All
Fields]))) OR (("conventional"[All Fields] OR "conventionals"[All Fields]) AND ((((((((("rotate"[All Fields]
OR "rotated"[All Fields]) OR "rotates"[All Fields]) OR "rotating"[All Fields]) OR "rotation"[MeSH Terms])
OR "rotation"[All Fields]) OR "rotations"[All Fields]) OR "rotational"[All Fields]) OR "rotator"[All Fields])
OR "rotators"[All Fields]) AND (((((("instrument"[All Fields] OR "instrument s"[All Fields]) OR
"instrumentation"[MeSH Subheading]) OR "instrumentation"[All Fields]) OR "instruments"[All Fields])
OR "instrumented"[All Fields]) OR "instrumenting"[All Fields]))) OR (("conventional"[All Fields] OR
"conventionals"[All Fields]) AND (((((("drilled"[All Fields] OR "drilling"[All Fields]) OR "drillings"[All
Fields]) OR "mandrillus"[MeSH Terms]) OR "mandrillus"[All Fields]) OR "drill"[All Fields]) OR "drills"[All
Fields]))) OR (("rotaries"[All Fields] OR "rotary"[All Fields]) AND ((((("instrumentation"[MeSH
Subheading] OR "instrumentation"[All Fields]) OR "instrumentation s"[All Fields]) OR
"instrumentational"[All Fields]) OR "instrumentations"[All Fields]) OR "instrumention"[All Fields]))) OR
(("hand"[MeSH Terms] OR "hand"[All Fields]) AND ((((("instrumentation"[MeSH Subheading] OR
"instrumentation"[All Fields]) OR "instrumentation s"[All Fields]) OR "instrumentational"[All Fields]) OR
"instrumentations"[All Fields]) OR "instrumention"[All Fields]))
((((((((((("intraoperative complications"[MeSH Terms] OR ("intraoperative"[All Fields] AND
"complications"[All Fields])) OR "intraoperative complications"[All Fields]) OR ("intraoperative"[All
Fields] AND "complication"[All Fields])) OR "intraoperative complication"[All Fields]) OR
((((((("membranal"[All Fields] OR "membrane s"[All Fields]) OR "membraneous"[All Fields]) OR
"membranes"[MeSH Terms]) OR "membranes"[All Fields]) OR "membrane"[All Fields]) OR
Outcome "membranous"[All Fields]) AND ((((((((((("perforant"[All Fields] OR "perforants"[All Fields]) OR
"perforate"[All Fields]) OR "perforated"[All Fields]) OR "perforates"[All Fields]) OR "perforating"[All
(O) Fields]) OR "perforation"[All Fields]) OR "perforations"[All Fields]) OR "perforative"[All Fields]) OR
"perforator"[All Fields]) OR "perforator s"[All Fields]) OR "perforators"[All Fields]))) OR
((((((((((("perforant"[All Fields] OR "perforants"[All Fields]) OR "perforate"[All Fields]) OR
"perforated"[All Fields]) OR "perforates"[All Fields]) OR "perforating"[All Fields]) OR "perforation"[All
Fields]) OR "perforations"[All Fields]) OR "perforative"[All Fields]) OR "perforator"[All Fields]) OR
"perforator s"[All Fields]) OR "perforators"[All Fields])) OR ((((("nasal mucosa"[MeSH Terms] OR
("nasal"[All Fields] AND "mucosa"[All Fields])) OR "nasal mucosa"[All Fields]) OR ("schneiderian"[All
Fields] AND "membrane"[All Fields])) OR "schneiderian membrane"[All Fields]) AND
((((((((((("perforant"[All Fields] OR "perforants"[All Fields]) OR "perforate"[All Fields]) OR
"perforated"[All Fields]) OR "perforates"[All Fields]) OR "perforating"[All Fields]) OR "perforation"[All
Fields]) OR "perforations"[All Fields]) OR "perforative"[All Fields]) OR "perforator"[All Fields]) OR
"perforator s"[All Fields]) OR "perforators"[All Fields]))) OR (((("operative time"[MeSH Terms] OR
("operative"[All Fields] AND "time"[All Fields])) OR "operative time"[All Fields]) OR ("surgical"[All Fields]
AND "time"[All Fields])) OR "surgical time"[All Fields])) OR (((((("surgical procedures, operative"[MeSH
Terms] OR (("surgical"[All Fields] AND "procedures"[All Fields]) AND "operative"[All Fields])) OR
"operative surgical procedures"[All Fields]) OR "surgical"[All Fields]) OR "surgically"[All Fields]) OR
"surgicals"[All Fields]) AND ("duration"[All Fields] OR "durations"[All Fields]))) OR

55
 (((((((((((((((((((("embryo implantation"[MeSH Terms] OR ("embryo"[All Fields] AND "implantation"[All
Fields])) OR "embryo implantation"[All Fields]) OR "implantation"[All Fields]) OR "implant"[All Fields])
OR "implant s"[All Fields]) OR "implantability"[All Fields]) OR "implantable"[All Fields]) OR
"implantables"[All Fields]) OR "implantate"[All Fields]) OR "implantated"[All Fields]) OR
"implantates"[All Fields]) OR "implantations"[All Fields]) OR "implanted"[All Fields]) OR "implanter"[All
Fields]) OR "implanters"[All Fields]) OR "implanting"[All Fields]) OR "implantion"[All Fields]) OR
"implantitis"[All Fields]) OR "implants"[All Fields]) AND ((((((((((((((((((("stabile"[All Fields] OR
"stabiles"[All Fields]) OR "stabilisation"[All Fields]) OR "stabilisations"[All Fields]) OR "stabilise"[All
Fields]) OR "stabilised"[All Fields]) OR "stabiliser"[All Fields]) OR "stabilisers"[All Fields]) OR
"stabilises"[All Fields]) OR "stabilising"[All Fields]) OR "stabilities"[All Fields]) OR "stability"[All Fields])
OR "stabilization"[All Fields]) OR "stabilizations"[All Fields]) OR "stabilize"[All Fields]) OR
"stabilized"[All Fields]) OR "stabilizer"[All Fields]) OR "stabilizers"[All Fields]) OR "stabilizes"[All
Fields]) OR "stabilizing"[All Fields]))) OR (((("postoperative complications"[MeSH Terms] OR
("postoperative"[All Fields] AND "complications"[All Fields])) OR "postoperative complications"[All
Fields]) OR ("postoperative"[All Fields] AND "complication"[All Fields])) OR "postoperative
complication"[All Fields])) OR ((((((("postoperative period"[MeSH Terms] OR ("postoperative"[All
Fields] AND "period"[All Fields])) OR "postoperative period"[All Fields]) OR "postop"[All Fields]) OR
"postoperative"[All Fields]) OR "postoperatively"[All Fields]) OR "postoperatives"[All Fields]) AND
(((((("epidemiology"[MeSH Subheading] OR "epidemiology"[All Fields]) OR "morbidity"[All Fields]) OR
"morbidity"[MeSH Terms]) OR "morbid"[All Fields]) OR "morbidities"[All Fields]) OR "morbids"[All
Fields])

4.5 Selection criteria and data extraction

The articles found underwent analysis by the author through three level of
screening (Level one; Title, Level two; Abstracts, Level three; Full text) in order
to ensure they comply with the inclusion and exclusion criteria set by the
author. Once the electronic search was conducted and the titles screening
completed, the abstracts of the remaining articles were reviewed, and the
inclusion criteria was applied to generate or determine the number of full text
articles for selection.

Critical appraisal was conducted on the selected studies which were relevant
to the inclusion criteria using the checklist of critical appraisal skills
programme (CASP, 2018), ‘Robis’ and ‘Amstar 2’ for systematic review, to
increase the accuracy and reduce the possibility of bias the quality of the
included reviews was assessed.

56
4.6 Ethical approval

An ethical form was attached with the protocol and submitted to the chair of BPP
school of health research ethics committee, although this is an umbrella review of
systematic reviews devoid of any risks and does not require an ethical approval.

5 Results

5.1 Outcome of literature search

The initial search with direct comparison with combination ; ‘P AND I OR C

AND O’ on the electronic database; PubMed yield a total of 20 articles.
Following the application of the inclusion and exclusion criteria on the search ;
Systematic reviews and meta-analysis comparing piezoelectric with traditional
rotatory and hand instrumentation for lateral maxillary sinus elevation
reporting on intra-operative outcomes and post-operative outcomes such as
membrane perforation, operative time, morbidity rate and implant stability rate.
Human studies with age >18years.Reviews not involving patients under-taking
bisphosphonates. Studies in English language only. Studies published from
2010-2020 (10-years) Exclusion Studies on trans-alveolar techniques, In vitro-
studies, any other type of study, Systematic reviews involving patients on
medications, Systematic reviews involving immunocompromised patients,
History or concurrent sinus pathology. Studies with published abstracts only.
After level one screening of 20 articles, there were 5 articles retained at level
two screening. A total of 15 articles were excluded at level one screening as
they were not relevant to the research question. At level two screening a total
of 4 articles were retained, one article was excluded as it was not focusing on
the research question as outcome under evaluation were not considered. At
the level three screening 5 articles were retained, one article was included
manually through bibliography of selected article.

57
Figure 3. 11: Search strategy and Exclusion at different levels.

58
Table 5. 1: Summary of the findings of included articles (organized
chronologically)

59
60
61
Results and critical appraisal of included articles

Summary of the article: Piezoelectric surgery vs Rotary instruments for lateral

maxillary sinus floor Elevation: A systematic review and meta-analysis of Intra-
and Postoperative complications (Atieh et al, 2015)
The aim of this systematic review was to examine the intra- and postoperative
events associated with the use of PEDs and conventional rotary instruments for
LMSFE. Perforations of the Schneiderian membrane may occur as an inter-
operative complication of maxillary sinus augmentation. The aim of this study was
to compare the incidence of membrane perforations between conventional
rotating instruments and piezoelectric devices in a meta-analysis.
In case of less residual height for implants, sinus floor elevation with lateral
approach (LASFE) is regenerative option derived from Caldwell-Luc approach to
re-establish adequate crestal height to place an implant. In this technique a bony
window is created in the lateral wall of the sinus followed by elevation of the sinus
membrane lining. Autogenous particulate iliac bone may then be inserted beneath
the elevated membrane and allowed to heal for 3 months before implant
placement. Rotary instruments are used to perform antrostomy and are
associated with membrane perforation risks. Therefore, Piezoelectric surgery
reported of less evidences related to membrane perforations.

Three electronic databases were searched for articles relevant in the context of
this systematic review: MEDLINE, EMBASE, The Cochrane Central Register of
Controlled Trials (CENTRAL), Meta Register, ClinicalTrials.gov, This review
included randomized controlled trials (RCTs), nonrandomized controlled clinical
trials (CCTs), and retrospective human studies that compared PEDs with
conventional surgical techniques for LMSFE and reported on intra- and

62
postoperative outcomes, such as sinus membrane perforation, operating time,
and implant failure rate for both groups. No language restrictions were imposed.

Only human studies were included. The study received no external funding. Two
reviewers screened the articles. Any disagreements between reviewers were
resolved by discussion to reach a consensus. Extra information was obtained by
contacting corresponding authors of the studies included. Meta-analysis was
performed. A statistical software program (Review Manager (Rev-Man) version
5.0, The Nordic Cochrane Centre. Case series and case reports were excluded.
After reviewing the titles and abstracts 116 were excluded. Patients with history
of systemic disease, current maxillary sinus pathology, smoking more than 10
cigarettes per day, Patients consuming antibiotics or steroids on the day or at
least 30 days before surgery and patients who did not comply with the study
protocol or follow-up regimen were placed in exclusion list.
The overall meta-analysis showed a statistically significant difference in the
operating time between the two techniques with more time required for PED. With
the exception of prolonged operating time associated with the use of PEDs, both
techniques were comparable in terms of the number of perforations and the risk
of implant failure.

63
Table 5. 2: Critical appraisal of Atieh et al (2015) using CASP tool (2018)

64
Table 5. 3: Critical appraisal of Atieh et al (2015) using AMSTAR-2 tool (2017).

Piezoelectric Surgery vs Rotary Instruments for Lateral Maxillary Sinus Floor Elevation: A Sstematic
Review and Meta-Analysis of Intra- and Postoperative Complications (Atieh et al, 2015).
Did the research Yes, emphasis was laid on the question “Does the use of PEDs for LMSFE reduce
question and inclusion the risk of membrane perforation, require reasonable operating time, and improve
criteria include the the survival rate of oral implants?”
components of PICO? Population- Patients requiring lateral maxillary sinus floor elevation
Intervention – Piezoelectric surgery
Comparator- Conventional rotary instruments or lateral antrostomy
Outcome - Intraoperative events (membrane perforation and operating time) and
postoperative complications, including implant failure
Did the report of the Partial Yes. A clearly focused question was present, search strategy was well
review contain explicit defined. Inclusion and exclusion criteria were also well defined. There was no
statement that the deviation from the inclusion or exclusion criteria during the screening process by
review methods were the authors. No Risk of bias assessment was carried out of the included
established prior to the publications. Meta-analysis was conducted.
conduct of the review?
Did the review authors Yes, Screening was done by two reviewers.
explain their selection of Electronic databases were screened for articles. Systemically healthy patients with
the study designs for no history of radiotherapy in head and neck region or reconstructive pre-prosthetic
inclusion in their review? or implant surgery, severely resorbed maxilla; class V or VI according to Cawood
and Howell classification, residual bone
height of less than 5 -6mm and Partial or total maxillary edentulism cases were
addressed in inclusion criteria. Mentioned in table 2.
Comprehensive Partial Yes. Keywords and search strategy have been described and mentioned
literature search well in the review. No language restriction was applied, to limit the selection of bias.
strategy?
Did the review authors Yes. Two reviewers (M.A.A. and N.H.M.A.) independently screened the retrieved
perform study selection citations in duplicate to identify RCTs, CCTs, and retrospective studies. The initial
in duplicate? citations were assessed on the basis of the title, abstract and keywords. The
relevant papers were then obtained in full and assessed for inclusion by using an
eligibility form. Any disagreements were resolved by reaching a consensus. The
reasons for excluding irrelevant papers were reported.

65
Did the review authors
performed data
extraction in duplicate?
Did the review authors
provide a list of
excluded studies and
justify the exclusions?
Did the authors
described the included
studies in detail?
Did the review authors
use a satisfactory
technique for assessing
the risk of bias (RoB)?
Did the review authors
report on the sources of
funding for the studies
included in the review?
If meta-analysis was
performed did the review
authors use appropriate
methods for statistical
combination of results?
If meta-analysis was
performed, did the
review authors assess
the potential impact of
RoB in individual studies
on the results of the
meta-analysis or other
evidence synthesis?
Yes. Two blinded independent authors performed data extraction, in duplicate
based upon study characteristics, interventions and participants.
Yes. Case series and case reports were excluded. After reviewing the titles and
abstracts 116 were excluded. Patients with history of systemic disease, current
maxillary sinus pathology, Smoking more than 10 cigarettes per day, Patients
consuming antibiotics or steroids on the day or at least 30 days before surgery and
patients who did not comply with the study protocol or follow-up regimen were
placed in exclusion list.
Yes. Included were all studies reporting on comparisons of MSA by the lateral
approach using PED and conventional techniques. Characteristics of included are
mentioned in Table 2.
Yes. The Cochrane Collaboration’s risk of bias tool was used by two
reviewers (M.A.A. and N.H.M.A.) to independently assess the
selected studies in duplicate to determine the risk of bias. The tool
consists of seven domains (sequence generation, allocation
concealment, blinding of participants and investigators, blinding of
outcome assessment, incomplete data outcome, selective outcome
reporting, and potential sources of bias).
This study received no external funding.
Yes, Meta-analysis was performed. A statistical software program (Review
Manager (Rev-Man) version 5.0, The Nordic Cochrane Centre, The Cochrane
Collaboration) was used to conduct the meta-analyses for trials of similar
comparisons reporting the same outcome measures.
Mentioned in Table 4,5 and 6.
Yes. Meta-analysis was performed, and the authors assessed the potentials of
RoB in individual studies. ROB mentioned in Fig 2 and 3.
66
Did the review authors Yes. The risk of bias assessment was performed.
account for RoB in 1) low risk of bias if all the criteria were met, (2) unclear risk of bias if one or more
individual studies when criteria were partially met, or (3) high risk of bias if one or more criteria were
interpreting/ discussing not met.
the results of the review?
Did the review authors Yes. A fixed-effects model was used to pool the results of more than one study,
provide a satisfactory except in studies with notable heterogeneity, in which case the random-effects
explanation for, and model was used. The statistical heterogeneity across different studies was
discussion of, any assessed by means of the Cochran test for heterogeneity and I2 statistic.
heterogeneity observed The outcomes of the two surgical techniques may vary.
in the results of the
review?
If they performed Partially Yes. One trial was judged to be at low risk of bias after additional
quantitative synthesis information was provided by the authors while the remaining three trials were
did the review authors judged to be at high risk of bias.
carry out an adequate
investigation of
publication bias (small
study bias) and discuss
its likely impact on the
results of the review?
Did the review authors No. The authors report no conflicts of interest related to this study nor any received
report any potential funding was reported by the authors.
sources of conflict of
interest, including any
funding they received?
for conducting the
review?

67
Table 5. 4 : Critical appraisal of Atieh et al (2015), using ROBIS tool (2016).

Phase 1 :

Category Target Question (Overview or guideline)

Population(s) Patients requiring lateral maxillary sinus floor augmentation.

Intervention(s) Piezoelectric surgery

Comparator(s) Conventional rotary instruments or lateral
antrostomy
Outcome(s) Intraoperative events (membrane perforation and operating
time) and postoperative complications, including implant
failure

Does the question address by the review YES

matched the target question?

Summary of Domain 1:
The aim of this systematic review was to examine the intra- and postoperative
events associated with the use of PEDs and conventional rotary instruments for
LMSFE. Study was conducted to compare the incidence of intra-operative events
between conventional rotating instruments and piezoelectric surgery. The
eligibility criteria comprised of including only human clinical trials mainly
randomized controlled trials though there was no language restriction. The
screening and selection were done with the help of two reviewers and Initial
screening was by title and then by abstract. The reviewers electronically and hand
searched the articles.

68
Phase 2: Identifying concerns with the review process
DOMAIN 1: STUDY ELIGIBILITY CRITERIA

1.1 Did the review adhere to pre-defined objectives and eligibility criteria? YES
1.2 Were the eligibility criteria appropriate for the review question? YES
1.3 Were eligibility criteria unambiguous? YES
1.4 Were any restrictions in eligibility criteria based on study YES
characteristics appropriate (e.g. date, sample size, study quality,
outcomes measured)?
1.5 Were any restrictions in eligibility criteria based on sources of NO
information appropriate (e.g. publication status or format, language,
availability of data)?
Concerns regarding specification of study eligibility criteria LOW

Summary of domain 2:
The following electronic databases were searched for ongoing and unpublished
trials up to December 9, 2013: MEDLINE, EMBASE, The Cochrane Central
Register of Controlled Trials (CENTRAL), Meta Register, ClinicalTrials.gov, and
the system for information on grey literature in Europe. Certain keywords: dental
implants, maxillary sinus floor elevation, meta-analysis, piezo surgery, review
were used to make the search reliable and relevant. Search was limited till 2015.

69
 DOMAIN 2: IDENTIFICATION AND SELECTION OF STUDIES

2.1 Did the search include an appropriate range of databases/electronic YES

sources for published and unpublished reports?
2.2 Were methods additional to database searching used to identify YES
relevant reports?
2.3 Were the terms and structure of the search strategy likely to retrieve YES
as many eligible studies as possible?
2.4 Were restrictions based on date, publication format, or language NO
appropriate?
2.5 Were efforts made to minimize error in selection of studies? YES
Concerns regarding methods used to identify and/or select studies LOW

Summary of domain 3:
In the study, data extraction was also conducted by two reviewers hence
reducing the risk of bias. Included were all studies reporting on comparisons of
MSA by the lateral approach using PED and conventional techniques.
Characteristics of included are mentioned in Table 2. The Cochrane
Collaboration’s risk of bias tool was used by two reviewers (M.A.A. and
N.H.M.A.) to independently assess the selected studies in duplicate to
determine the risk of bias. The tool consists of seven domains (sequence
generation, allocation concealment, blinding of participants and investigators,
blinding of outcome assessment, incomplete data outcome, selective outcome
reporting, and potential sources of bas).

70
DOMAIN 3: DATA COLLECTION AND STUDY APPRAISAL.

3.1 Were efforts made to minimize error in data collection? YES

3.2 Were sufficient study characteristics available for both review authors YES
and readers to be able to interpret the results?
3.3 Were all relevant study results collected for use in the synthesis? YES
3.4 Was risk of bias (or methodological quality) formally assessed using NO
appropriate criteria?
3.5 Were efforts made to minimize error in risk of bias assessment? YES

Concerns regarding methods used to collect data and appraise studies LOW

Summary of domain 4:
Meta-analysis was performed. A statistical software program (Review Manager
(Rev-Man) version 5.0, The Nordic Cochrane Centre, The Cochrane
Collaboration) was used to conduct the meta-analyses for trials of similar
comparisons reporting the same outcome measures. Mentioned in Table 4,5 and
6. The risk of bias assessment was performed. “Low” risk of bias if all the criteria
were met, “Unclear” risk of bias if one or more criteria were partially met, or “High”
risk of bias if one or more criteria were no.t met.
DOMAIN 4: SYNTHESIS AND FINDINGS.

4.1 Did the synthesis include all studies that it should? YES
4.2 Were all pre-defined analyses reported or departures explained? YES
4.3 Was the synthesis appropriate given the nature and similarity in YES
the research questions, study designs and outcomes across
included studies?
4.4 Was between-study variation (heterogeneity) minimal or YES
addressed in the synthesis?
4.5 Were the findings robust, e.g. as demonstrated through funnel YES
plot or sensitivity analyses?
4.6 Were biases in primary studies minimal or addressed in the YES
synthesis?
Concerns regarding the synthesis and findings LOW

71
Phase 3: Judging risk of bias

Summarize the concerns identified during the Phase 2 assessment:

Domain Concern Rationale for concern

The study has a focused question, the eligibility criteria and specifications have been mentioned
along with the comparison of the incidence of post-operative events between conventional
1. LOW rotating instruments and piezoelectric surgery.

Search strategy has been clearly mentioned by the author, keywords and mesh terms have
been mentioned along with the language of the articles that need to be retrieved. Three
electronic databases were searched for articles relevant in the context of this systematic review:
MEDLINE, EMBASE, The Cochrane Central Register of Controlled Trials (CENTRAL), Meta
2. LOW Register. Only human studies but in any language.

The data extraction was done by two reviewers thereby minimizing bias. The authors have
displayed the characteristics of the included articles in a tabulated form in the article. Risk of
3. LOW bias was mentioned in review as high, low and unclear.

The synthesis and findings are clearly illustrated in a tabulated form in the publication by the
authors, constituting of type of study control and test group along with the results and P-value.
4. LOW

RISK OF BIAS IN THE REVIEW

A. Did the interpretation of findings address all the concerns YES

identified in Domains 1 to 4?
B. Was the relevance of identified studies to the review's research YES
question appropriately considered?
C. Did the reviewers avoid emphasizing results based on their YES
statistical significance?
Risk of bias in the review RISK: LOW

72
Summary of the article: A meta-analysis of complications during sinus
augmentation procedure (Geminiani et al, 2017)
After tooth extraction insufficient bone height is usually the outcome because of
remodeling and sinus pneumatization. Maxillary sinus lifts allow proper implant
supported rehabilitations. Access to sinus is made by creating window on lateral
wall by burs or surgical motors. Another approach is trans-crestal maxillary sinus
elevation and subsequent placement of implant. Techniques consisted of
preparing the implant site with a “socket former” and then fracturing the sinus floor
by hand tapping the socket former in a vertical direction. Sinus floor augmentation
surgery, However, remains a technique-sensitive procedure and the risk of
complications is always present. Perforation of Schneiderian membrane and
bleeding from vascular lesions falls in post-operative complications. To minimize
such complications surgical variants have been proposed like the use of ultrasonic
devices, bone scrapers and specially designed burs.

Three electronic databases were searched for articles relevant in the context of
this systematic review: National Library of Medicine (MEDLINE—PubMed),
Embase and Scopus. Only human studies were included with no language
specifications or restrictions. The study received no external funding. Two
reviewers screened the articles. Any disagreement in the final selection was
resolved by open discussion between both reviewers. In the case that no
agreement could be reached, the other co-author acted as arbiter. Characteristics
of included studies were illustrated in tables and flow charts. Meta-Analysis was
conducted. Risk of bias was conducted.
Electronic and manual searches identified 3,940 articles. The further research at
the title level was 922 articles and 53 articles were found after the abstract level
screening; 30 articles were included for full-text reading. Among these full-text
reading articles, 11 studies were included for further evaluation and 19 studies
were excluded due to not falling in the inclusion criteria. A total of 5 randomized
clinical trials and 6 retrospective studies were used for statistical analysis. Mantel-

73
Haenszel log odds ratio (−1.05; 95% CI −1.98 to −0.11) showed a significantly
lower incidence of sinus and/or wound infection in the “alternative” technique
group.
One of the major limitations of this review is that the body of literature included is
limited to 11 articles (five RCTs and six retrospective studies). Further clinical
trials should be designed and conducted to assess the benefits of the existing
alternative techniques for sinus augmentation surgery.
Within the limitations of the present study, it is concluded that the use of
“alternative” techniques (piezosurgery, sonic, osteotome, and trephine) for sinus
floor augmentation surgery, does not significantly reduce the incidence of
intraoperative perforation of sinus membrane, nor does it significantly reduce the
length of the surgical intervention when compared to conventional lateral window
sinus floor augmentation surgery.

74
Table 5. 5: Critical appraisal of Geminiani et al (2017) using CASP tool (2018)

A meta-analysis of complications during sinus augmentation procedure (Geminiani et al,

2017).
Did the study address Yes, In adult patients requiring sinus floor augmentation surgery, does a
clearly focus question? lateral window conventional approach compared to alternative surgical
techniques reduce the incidence of intraoperative and postoperative
complications?”

Population- Adult patients requiring sinus floor augmentation surgery

Intervention – Lateral window conventional approach.

Comparator- Alternative surgical techniques
Outcome - Reduce the incidence of intraoperative and postoperative

Complications

Did the authors use an Electronic and manual searches resulted Initial search returned 3,940
appropriate type of articles after
papers? inclusion/exclusion criteria, and quality assessment 11 articles were
included in the meta-analysis: five randomized clinical trials and six
retrospective studies.
Were all the studies Yes, thorough explanation of inclusion and exclusion criteria were given.
included relevant and Three electronic databases were searched for articles relevant in the
important? context of this systematic review: National Library of Medicine (MEDLINE—
PubMed), Embase, Cochrane Central Register of controlled trials. Only
human studies that too in English language. A detailed protocol was
developed and agreed upon by the authors.
Was the quality of the Yes, Data was assessed by two reviewers. Any conflict was solved out by
included studies rest of the contributors. Inclusions and their characteristics have been stated
assessed thoroughly in table 1 and 2.
by the authors?
Were the results of the Yes. Tabulated results have been stated for every demanded aspect of
study combined, was it study.
reasonable to do so?
Results Electronic and manual searches identified 3,940 articles. The further
research at the title level was 922 articles and 53 articles were
found after the abstract level screening; 30 articles were included for full-
text reading.
Among these full-text reading articles, 11 studies were included for further
evaluation and 19 studies were excluded due to not falling in the inclusion

75
 criteria. A total of 5 randomized clinical trials and 6 retrospective studies
were used for statistical analysis. Mantel-Haenszel log odds ratio (−1.05;
95% CI −1.98 to −0.11) showed a significantly lower incidence of sinus
and/or wound infection in the “alternative” technique group. Using
alternative techniques do not decrease the incidence of perforation and
length of surgical intervention significantly.
Can the results be Yes, the results can be applied locally and globally as per easy access of
applied to the local materials and techniques. Simple inclusion and exclusion criteria has been
population? stated. Adult age group has been taken to form the population group only.
Were all important Yes, all important outcomes related to lateral maxillary augmentation in
outcomes considered? various dimensions were considered.

Are the benefits worth Sinus membrane perforation being the most frequent intraoperative
the harm and costs? complication during sinus floor elevation with a lateral approach, thinning
the lateral wall of the sinus before performing the antrostomy (either with
ultrasonic devices or manual bone scrapers) was found to be an important
factor in preventing membrane perforation during surgery.

76
Table 5. 6: Critical appraisal of Geminiani et al (2017) using AMSTAR-2 tool (2017)

A meta-analysis of complications during sinus augmentation procedure (Geminiani

et al, 2017)
Did the research Yes, In adult patients requiring sinus floor augmentation surgery,
question and inclusion does a lateral window conventional approach compared to
criteria include the alternative surgical techniques reduce the incidence of
components of PICO? intraoperative and postoperative complications?”
Population- Adult patients requiring sinus floor augmentation
surgery
Intervention – Lateral window conventional approach.
Comparator- Alternative surgical techniques
Outcome - Reduce the incidence of intraoperative and
postoperative
Complications
the follow-up time should be at least up to 6 months after surgery.

Did the report of the Yes. A clearly focused question was present, search strategy was
review contain explicit well defined. Inclusion and exclusion criteria were also well
statement that the defined. There was no deviation from the inclusion or exclusion
review methods were criteria during the screening process by the authors. Risk of bias
established prior to assessment was carried out of the included publications in the
the conduct of the study and graded as low, unclear or high.
review?
Did the review authors Yes, Screening was done by two reviewers.
explain their selection Three electronic databases: The PubMed, Embase and
of the study designs Cochrane Central databases were screened for articles. List of
for inclusion in their included studies is mentioned by the authors.
review?
Comprehensive Partial Yes. Keywords and search strategy have been described
literature search and mentioned well in the review. English language was
strategy? considered only.
Did the review authors Yes. Articles were collected in reference manager software
perform study (EndNote, Thomson Reuters) and duplicates were discarded
selection in duplicate? electronically. Titles and abstracts were initially screened by two

77
 calibrated reviewers (AG and AT) for potential inclusion. If no
abstract was available in the database, the abstract of the printed
article was used. The full-text reading of related publications was
carried out independently by two reviewers (AG and AT). The
electronic search was supplemented by manual search.
Did the review authors Yes. Two blinded independent authors performed, in duplicate.
performed data Inter-reviewer
extraction in agreement was determined with the use of Cohen’s kappa
duplicate? statistics (k-score). In cases where information was not clear, the
authors of the pertinent study were
contacted by email to elucidate the issue.
.
Did the review Yes. Reasons of exclusion were precise and to the point. Those
authors provide a
studies were excluded which had insufficient data from a
list of excluded
studies and justify study in order to calculate
the exclusions? the number of complications, no email response to inquiry
email to the corresponding author regarding each study,
multiple publications on the same cohort of patients, only the
most recent will be included and animal or cadaver studies.
Mentioned in Fig 5.
Did the authors Yes. Characteristics and outcomes of included criterion
described the mentioned. Only, clinical studies in English language were
included studies in considered that reported on at least 10 or more
detail? patients, on any sinus floor augmentation technique and
complications with follow-up time of at least up to 6 months after
surgery in English language. Mentioned in Table 1 and 2.
Did the review authors Yes. Two authors independently determined the risk of
use a satisfactory bias of each study included in the final selection using the
technique for Cochrane
assessing the risk of Collaboration's tool for assessing risk of bias in randomized
bias (RoB)? clinical, regarding all the other study designs.

Did the review authors This study received no external funding.

report on the sources
of funding for the
studies included in the
review?

78
If meta-analysis was This systematic review and meta-analysis was conducted
performed did the in accordance with the guidelines of Transparent
review authors use
Reporting of Systematic Reviews and Meta-analyses
appropriate methods
(PRISMA statement).
for statistical
combination of
results?
If meta-analysis was Yes, meta-analysis was conducted. meta-analysis were
performed, did the assessed by Cochrane Collaboration’s tool. “High risk of bias”,
review authors assess “low risk of bias”, or “unclear risk of bias” was assigned to each
the potential impact of assessment item. The quality assessment of the retrospective
RoB in individual cohort studies was utilized by the Newcastle–Ottawa
studies on the results scale (NOS).
of the meta-analysis
or other evidence
synthesis?
Did the review authors Yes. Detailed information on the risk of bias in individual studies
account for RoB in is reported and mentioned in table 3.
individual studies
when interpreting/
discussing the results
of the review?
Did the review authors Yes. The authors did discuss the variation. Adult age group was
provide a satisfactory considered.
explanation for, and
discussion of, any
heterogeneity
observed in the
results of the review?
If they performed Partially Yes.
quantitative synthesis
did the review authors
carry out an adequate
investigation of
publication bias (small
study bias) and
discuss its likely
impact on the results
of the review?

79
 Did the review authors No. The authors report no conflicts of interest related to this study
report any potential nor any received funding was reported by the authors.
sources of conflict of
interest, including any
funding they
received? for
conducting the
review?

Table 5. 7: Critical appraisal of Geminiani et al (2017) using ROBIS tool

(2016)

Phase 1:

Category Target Question (Overview or guideline)

Population(s) Adult patients requiring sinus floor augmentation surgery

Intervention(s) Lateral window conventional approach.

Comparator(s) Alternative surgical techniques

Outcome(s) Reduce the incidence of intraoperative and postoperative

Complications

Does the question address by the review YES

matched the target question?

80
Summary of Domain 1:
The study was conducted analyze the clinical complications of LASFE (intraoperative
and postoperative complication) and its correlation with other techniques adopted by
surgeons. The eligibility criteria comprised of including only human clinical trials
mainly randomized controlled trials though there was no language barrier. The
screening and selection were done with the help of two reviewers and if they two
got uncertain over the inclusion of an article then other authors were engaged for
consensus. Initial screening was by title and then by abstract. The reviewers
electronically and manually searched out the articles.

Phase 2: Identifying concerns with the review process

DOMAIN 1: STUDY ELIGIBILITY CRITERIA

1.1 Did the review adhere to pre-defined objectives and eligibility criteria? YES
1.2 Were the eligibility criteria appropriate for the review question? YES
1.3 Were eligibility criteria unambiguous? YES
1.4 Were any restrictions in eligibility criteria based on study NO
characteristics appropriate (e.g. date, sample size, study quality,
outcomes measured)?
1.5 Were any restrictions in eligibility criteria based on sources of NO
information appropriate (e.g. publication status or format, language,
availability of data)?
Concerns regarding specification of study eligibility criteria High

81
DOMAIN 2: IDENTIFICATION AND SELECTION OF STUDIES

2.1 Did the search include an appropriate range of databases/electronic YES

sources for published and unpublished reports?

2.2 Were methods additional to database searching used to identify YES

relevant reports?

2.3 Were the terms and structure of the search strategy likely to retrieve YES

as many eligible studies as possible?

2.4 Were restrictions based on date, publication format, or language NO

appropriate?

2.5 Were efforts made to minimize error in selection of studies? YES

Concerns regarding methods used to identify and/or select studies LOW

Summary of domain 3:
In the study, data extraction was also conducted by two reviewers hence
reducing the risk of bias. Characteristics of the included studies are presented in
Table 2., Two authors independently determined the risk of bias of each study
included in the final selection using the Cochrane Collaboration's tool for
assessing risk of bias in randomized clinical Trials. Random sequence
generation, Allocation concealment, blinding of participants and personnel;
Blinding of outcome assessment; Incomplete outcome data; Selective reporting
identical treatment group and report of follow up.

82
DOMAIN 3: DATA COLLECTION AND STUDY APPRAISAL

3.1 Were efforts made to minimize error in data collection? YES

3.2 Were sufficient study characteristics available for both review authors NO
and readers to be able to interpret the results?
3.3 Were all relevant study results collected for use in the synthesis? YES
3.4 Was risk of bias (or methodological quality) formally assessed using YES
appropriate criteria?
3.5 Were efforts made to minimize error in risk of bias assessment? YES

Concerns regarding methods used to collect data and appraise studies LOW

Summary of domain 4:
Meta-analysis was conducted. Meta-analysis was assessed by Cochrane
Collaboration’s tool. “High risk of bias”, “low risk of bias”, or “unclear risk of bias”
was assigned to each assessment item. The quality assessment of the
retrospective cohort studies was utilized by the Newcastle–Ottawa scale (NOS).
the synthesis included all the studies and the outcome under evaluation was
highlighted in all the publications.
DOMAIN 4: SYNTHESIS AND FINDINGS

4.1 Did the synthesis include all studies that it should? NO

4.2 Were all pre-defined analyses reported or departures explained? YES
4.3 Was the synthesis appropriate given the nature and similarity in YES
the research questions, study designs and outcomes across
included studies?
4.4 Was between-study variation (heterogeneity) minimal or YES
addressed in the synthesis?
4.5 Were the findings robust, e.g. as demonstrated through funnel NO
plot or sensitivity analyses?
4.6 Were biases in primary studies minimal or addressed in the NO
synthesis?
Concerns regarding the synthesis and findings HIGH

83
Phase 3: Judging risk of bias

Summarize the concerns identified during the Phase 2 assessment:

Domain Concern Rationale for concern

The study has a focused question, the eligibility criteria and specifications have been
mentioned along with the outcome which is - Intraoperative complications following
1. HIGH sinus elevation by lateral approach.

Search strategy has been clearly mentioned by the author, keywords and mesh terms
have been mentioned along with the language of the articles that need to be retrieved
(any language) making the concern in this domain. Three reliable databases were used
PubMed, EMBASE and Cochrane Central reference lists of included articles were also
2. LOW screened by two reviewers.

The data extraction was done by two reviewers thereby minimizing bias. The authors
have displayed the characteristics of the included articles in a tabulated form in the
3. LOW article. Risk of bias of the included studies was also assessed.

The synthesis and findings are clearly illustrated in a tabulated form in the publication
by the authors, constituting of type of study control and test group along with the results
4. HIGH and P-value. Limitations in this review require further clinical trials.

RISK OF BIAS IN THE REVIEW

A. Did the interpretation of findings address all the concerns YES

identified in Domains 1 to 4?
B. Was the relevance of identified studies to the review's research YES
question appropriately considered?
C. Did the reviewers avoid emphasizing results based on their YES
statistical significance?
Risk of bias in the review RISK: LOW

84
Summary of the article: Membrane perforation rate in lateral maxillary sinus floor
augmentation using conventional rotating instruments and piezoelectric device—
a meta-analysis (Jordi et al, 2018)

Maxillary sinus augmentation (MSA) is a successful and predictable intervention

with low complication rates. Perforations of the Schneiderian membrane may
occur impairing the general success. The aim of this study was to compare the
incidence of membrane perforations between conventional rotating instruments
and piezoelectric devices in a meta-analysis. When residual bone height is not
sufficient for implant placement, but inter-arch relationships are preserved, sinus
floor elevation with lateral approach (LASFE) is regenerative option derived from
Caldwell-Luc approach to re-establish adequate crestal height to place an
implant. A bony window is made in the cavity, membrane is lifted, walls are
curettage. Space is grafted with autogenous bone graft or auto grafts to allow
insertion of implants of desired lengths. Rotary instruments are used to perform
antrostomy and are associated with membrane perforation risks.

Three electronic databases were searched for articles relevant in the context of
this systematic review: National Library of Medicine (MEDLINE—PubMed),
Embase, Cochrane Library and Web of Science. Only human studies but in any
language. A detailed protocol was developed and agreed upon by the authors.
They included 21 RCTs and 11 prospective CCTs. Only human studies were
included with no language specifications or restrictions. The study received no
external funding. Two reviewers screened the articles. Any disagreement in the
final selection was resolved by authors themselves. The search provided 377
articles of which 69 could be included. Selected non-randomized and non-
controlled prospective and retrospective studies were incorporated. Conventional
rotary instruments were associated with a perforation rate of 24%, the
piezoelectric devices with 8% with statistically significant difference between both

85
modalities (p < 0.05). The forest plots generally show a higher perforation rate for
conventional sinus lift when compared to piezo surgery.

Excluded were studies describing any other procedure than the lateral approach
for MSA, missing information on the occurrence of membrane perforation and in
vitro studies. Study characteristics: title, authors’ name, year of publication, study
design, number of sinus floor elevations (SFE), Interventions: the use of
piezoelectric devices or rotary instruments for SFE, Outcomes: number and
percentage of membrane perforation were excluded. Meta-Analysis was
conducted using the Comprehensive Meta-Analysis (Version 3) (Bio stat,
Englewood, USA) applying the sample size of each study and the event rate (e.g.
perforation of the membrane or not). Impact of ROB was not stated in this review.
While incorporating selected non-randomized and non-controlled prospective and
retrospective studies, our current data show that there is less perforation of the
Schneiderian membrane when using piezo surgery. Hence, drawn out from the
review was membrane perforations in MSA may be significantly reduced applying
piezo electrical devices for MSA. However, More RCTs focusing on membrane
perforation are needed for a final conclusion on this topic.

86
Table 5. 8: Critical appraisal of Jordi et al (2018) using CASP tool (2018).
Membrane perforation rate in lateral maxillary sinus floor augmentation using
conventional rotating instruments and piezoelectric device—a meta-analysis (Jordi
et al, 2018).
Did the study Yes, present meta-analysis aimed to compare the incidence of
address clearly membrane perforations between conventional rotating instruments and
focus question? piezoelectric
Devices.
Population- Patients requiring lateral maxillary sinus floor augmentation
Intervention – Piezoelectric device

Comparator- Conventional rotary instruments or lateral

antrostomy
Outcome - Membrane perforation rate.

Did the authors An electronic research on MEDLINE and PubMed database was
use an performed evaluating the
appropriate literature from 1980 till 2016.The database PubMed and the US National
type of papers? Library of
Medicine were screened from January 8, 2012, to January 6, 2016, for
potential studies reporting on membrane perforations during MSA from
1980 till 2015.
Were all the Yes, thorough explanation of inclusion and exclusion criteria were given.
studies included Three electronic databases were searched for articles relevant in the
relevant and context of this systematic review: National Library of Medicine
important? (MEDLINE—PubMed), Embase, Cochrane Library and Web of Science.
Only human studies but in any language. A detailed protocol was
developed and agreed upon by the authors. They included 21 RCTs and
11 prospective CCT
Was the quality Yes, Data was assessed by two reviewers. Any conflict was solved out
of the included by rest of the contributors.
studies .
assessed
thoroughly by
the authors?
Were the Yes. Tabulated results have been stated for every demanded aspect of
results of the study. Table 1 and 2 shows wide comparisons.
study
combined, was

87
it reasonable to
do so?

Results The search provided 377 articles of which 69 could be included. Selected
non-randomised and non-controlled prospective and retrospective
studies were incorporated. Conventional rotary instruments were
associated with a perforation rate of 24%, the piezoelectric devices with
8% with statistically significant difference between both modalities (p <
0.05).The forest plots generally show a higher perforation rate for
conventional sinus lift when compared to piezo surgery (Tables 1 and 2)
Can the Yes, the results can be applied locally and globally as per easy access
results be of materials and techniques. However financial suitability would be held
applied to the in account as per patient’s affordability. Simple inclusion and exclusion
local criteria have been stated. No age group limitation has been stated.
population?
Were all Yes, all important outcomes related maxillary sinus augmentation has
important been stated and discussed.
outcomes
considered?
Are the benefits Membrane perforations in MSA may be significantly reduced applying
worth the harm piezo electrical devices for MSA.piezo surgery, with its gentle cutting
and costs? process, is perfectly qualified for the maxillary sinus membrane elevation.

88
 Table 5. 9: Critical appraisal of Jordi et al (2018) using AMSTAR-2 tool (2017)

Membrane perforation rate in lateral maxillary sinus floor augmentation using conventional rotating
instruments and piezoelectric device—a meta-analysis (Jordi et al, 2018).
Did the research question Yes, present meta-analysis aimed to compare the incidence of membrane
and inclusion criteria include perforations between conventional rotating instruments and piezoelectric
the components of PICO? Devices.
Population- Patients requiring lateral maxillary sinus floor augmentation
Intervention – Piezoelectric device
Comparator- Conventional rotary instruments or lateral antrostomy
Outcome - Membrane perforation rate
Did the report of the review Partial Yes. A clearly focused question was present, search strategy was well
contain explicit statement defined. Inclusion and exclusion criteria were also well defined. There was no
that the review methods deviation from the inclusion or exclusion criteria during the screening process by
were established prior to the the authors. No Risk of bias assessment was carried out of the included
conduct of the review? publications. Meta-analysis was conducted .
Did the review authors Yes, Screening was done by two reviewers.
explain their selection of the Electronic databases were screened for articles. Included were all studies
study designs for inclusion in reporting on the amount of membrane perforations during MSA by the lateral
their review? approach. Prospective and retrospective cohort studies and case series were
also included. Both studies with split mouth design and also studies without
control group were also included.
Comprehensive literature Partial Yes. Keywords and search strategy have been described and mentioned
search strategy? well in the review. No language restriction was applied, to limit the selection of
bias.
Did the review authors Yes. The search was conducted independently and in duplicate by
perform study selection in two authors (MK and JC). The database PubMed and the US National Library of
duplicate? Medicine were screened from January 8, 2012, to
January 6, 2016, for potential studies reporting on membrane
perforations during MSA.
Did the review authors Yes. Two blinded independent authors performed data extraction, in duplicate.
performed data extraction in
duplicate?
Did the review authors Yes. Excluded were studies describing any other procedure than the lateral
provide a list of excluded approach for MSA, missing information on the occurrence of membrane

89
 studies and justify the perforation and in vitro studies. Study characteristics: title, authors’ name, year
exclusions? of publication, study design, number of sinus floor
elevations (SFE), Interventions: the use of piezoelectric devices or
rotary instruments for SFE, Outcomes: number and percentage of membrane
perforation were excluded.
Did the authors described Yes. Included were all studies reporting on the amount of membrane perforations
the included studies in during MSA by the lateral approach. Prospective and retrospective cohort studies
detail? and case series were also included. Forest plots have been mentioned in fig 1
and 2.

Did the review authors use a Yes. Two authors independently determined the risk of
satisfactory technique for bias of each study included in the final selection using the Cochrane
assessing the risk of bias Collaboration's tool for assessing risk of bias in randomized clinical.
(RoB)? Trials. Random sequence generation, Allocation concealment, Blinding of
participants and personnel; Blinding of outcome assessment; Incomplete
outcome data; Selective reporting.
Did the review authors report This study received no external funding.
on the sources of funding for
the studies included in the
review?
If meta-analysis was Yes, Meta-analysis was performed with the studies matching the inclusion
performed did the review criteria. The incidence of perforations between conventional and piezo during
authors use appropriate the lateral maxillary sinus floor elevation was determined, and forest plots and a
methods for statistical t test for significance analysis were performed.
combination of results?

If meta-analysis was Yes-meta-analysis was performed using the Comprehensive Meta-Analysis

performed, did the review (Version 3) (Bio stat, Englewood, USA) applying the sample size of each study
authors assess the potential and the event rate (e.g. perforation of the membrane or not). Impact of ROB was
impact of RoB in individual not stated in this review.
studies on the results of the
meta-analysis or other
evidence synthesis?
Did the review authors NO. The risk of bias assessment was not performed.
account for RoB in individual
studies when interpreting/
discussing the results of the
review?
Did the review authors Yes. The authors did discuss the variation. significance analysis was performed
provide a satisfactory between both groups in terms of a t test. The significance levels
explanation for, and was set at p < 0.05.

90
discussion of, any
heterogeneity observed in
the results of the review?
If they performed Partially Yes.
quantitative synthesis did the
review authors carry out an
adequate investigation of
publication bias (small study
bias) and discuss its likely
impact on the results of the
review?
Did the review authors report No. The authors report no conflicts of interest related to this study nor any
any potential sources of received funding was reported by the authors.
conflict of interest, including
any funding they received?
for conducting the review?

Table 5. 10: Critical appraisal of Jordi et al (2018) using ROBIS tool (2016)

Phase 1:

Category Target Question (Overview or guideline)

Population(s) Patients requiring lateral maxillary sinus floor augmentation.

Intervention(s) Piezoelectric device

Comparator(s) Conventional rotary instruments or lateral
antrostomy
Outcome(s) Sinus Membrane Perforation

Does the question address by the review YES

matched the target question?

91
Summary of Domain 1:
The study was conducted to compare the incidence of membrane perforations
between conventional rotating instruments and piezoelectric. The eligibility criteria
comprised of including only human clinical trials mainly randomized controlled
trials though there was no language restriction. The screening and selection were
done with the help of two reviewers and Initial screening was by title and then by
abstract. The reviewers electronically searched out the articles.
Phase 2: Identifying concerns with the review process
DOMAIN 1: STUDY ELIGIBILITY CRITERIA

1.1 Did the review adhere to pre-defined objectives and eligibility criteria? YES
1.2 Were the eligibility criteria appropriate for the review question? YES
1.3 Were eligibility criteria unambiguous? YES
1.4 Were any restrictions in eligibility criteria based on study YES
characteristics appropriate (e.g. date, sample size, study quality,
outcomes measured)?
1.5 Were any restrictions in eligibility criteria based on sources of NO
information appropriate (e.g. publication status or format, language,
availability of data)?
Concerns regarding specification of study eligibility criteria LOW

Summary of domain 2:
An electronic research on MEDLINE and PubMed database was performed
evaluating the literature from 1980 till 2016.The database PubMed and the US
National Library of Medicine were screened from January 8, 2012, to January 6,
2016, for potential studies reporting on membrane perforations during MSA from
1980 till 2015.Certain keywords: Sinus lift, Conventional, Piezo surgery,
Schneiderian membrane, Perforation, Ultrasound elevation were used to make
the search reliable and relevant. Search was limited till 2017.

92
 DOMAIN 2: IDENTIFICATION AND SELECTION OF STUDIES

2.1 Did the search include an appropriate range of databases/electronic YES

sources for published and unpublished reports?
2.2 Were methods additional to database searching used to identify NO
relevant reports?
2.3 Were the terms and structure of the search strategy likely to retrieve NO
as many eligible studies as possible?
2.4 Were restrictions based on date, publication format, or language NO
appropriate?
2.5 Were efforts made to minimize error in selection of studies? YES
Concerns regarding methods used to identify and/or select studies HIGH

Summary of domain 3:
In the study, data extraction was also conducted by two reviewers hence
reducing the risk of bias. Characteristics of the included studies are presented in
Table 1 and 2. The forest plots generally show a higher perforation rate for
conventional sinus lift when compared to piezo surgery (Fig 1 and 2).
DOMAIN 3: DATA COLLECTION AND STUDY APPRAISAL

93
3.1 Were efforts made to minimize error in data collection? YES
3.2 Were sufficient study characteristics available for both review authors YES
and readers to be able to interpret the results?
3.3 Were all relevant study results collected for use in the synthesis? YES
3.4 Was risk of bias (or methodological quality) formally assessed using NO
appropriate criteria?
3.5 Were efforts made to minimize error in risk of bias assessment? YES

Concerns regarding methods used to collect data and appraise studies LOW

Summary of domain 4:
Meta-analysis was conducted. Meta-analysis was performed using the
Comprehensive Meta-Analysis (Version 3) (Bio stat, Englewood, USA) applying
the sample size of each study and the event rate (e.g. perforation of the
membrane or not). Impact of ROB was not stated in this review. Forest plots and
a t test for significance analysis were performed. The synthesis included all the
studies and the outcome under evaluation was highlighted in all the publications.
More RCTs focusing on membrane perforation are needed for a final conclusion.

DOMAIN 4: SYNTHESIS AND FINDINGS

94
 4.1 Did the synthesis include all studies that it should? NO
4.2 Were all pre-defined analyses reported or departures explained? YES
4.3 Was the synthesis appropriate given the nature and similarity in YES
the research questions, study designs and outcomes across
included studies?
4.4 Was between-study variation (heterogeneity) minimal or YES
addressed in the synthesis?
4.5 Were the findings robust, e.g. as demonstrated through funnel YES
plot or sensitivity analyses?
4.6 Were biases in primary studies minimal or addressed in the NO
synthesis?
Concerns regarding the synthesis and findings HIGH

Phase 3: Judging risk of bias

Summarize the concerns identified during the Phase 2 assessment:

Domain Concern Rationale for concern

The study has a focused question, the eligibility criteria and specifications have been mentioned
along with the comparison of the incidence of membrane perforations between conventional
1. LOW rotating instruments and piezoelectric.

Search strategy has been clearly mentioned by the author, keywords and mesh terms have
been mentioned along with the language of the articles that need to be retrieved. Three
electronic databases were searched for articles relevant in the context of this systematic review:
National Library of Medicine (MEDLINE—PubMed), Embase, Cochrane Library and Web of
2. HIGH Science. Only human studies but in any language.

95
 The data extraction was done by two reviewers thereby minimizing bias. The authors have
displayed the characteristics of the included articles in a tabulated form in the article. Risk of
3. LOW bias was not mentioned in review.

The synthesis and findings are clearly illustrated in a tabulated form in the publication by the
authors, constituting of type of study control and test group along with the results and P-value.
More RCTs focusing on membrane perforation are needed for a final conclusion.
4. HIGH

RISK OF BIAS IN THE REVIEW

A. Did the interpretation of findings address all the concerns YES

identified in Domains 1 to 4?
B. Was the relevance of identified studies to the review's research YES
question appropriately considered?
C. Did the reviewers avoid emphasizing results based on their YES
statistical significance?
Risk of bias in the review RISK: LOW

96
Summary of the article: Intra-operative Complications During sinus floor
elevation with lateral approach: A systematic Review (Stacchi et al, 2017).

After tooth extraction insufficient bone height is usually the outcome because of
remodeling and sinus pneumatization. Maxillary sinus lifts allow proper implant
supported rehabilitations. Access to sinus is made by creating window on lateral
wall by burs or surgical motors. Perforation of Schneiderian membrane and
bleeding from vascular lesions falls in post-operative complications. To minimize
such complications surgical variants have been proposed like the use of ultrasonic
devices, bone scrapers and specially designed burs.

Three electronic databases were searched for articles relevant in the context of
this systematic review: National Library of Medicine (MEDLINE—PubMed),
Embase and Scopus. Only human studies were included with no language
specifications or restrictions. The study received no external funding. Two
reviewers screened the articles. Any disagreement in the final selection was
resolved by open discussion between both reviewers. In the case that no
agreement could be reached, the other co-author acted as arbiter. Characteristics
of included studies were illustrated in tables and flow charts. No Meta-Analysis
was conducted. Risk of bias was conducted by Cochrane central, to assess other
CCT’s Modified Down and Black Checklist was used.
However, the reported studies had heterogeneity and limited quality, Conclusions
out of these were inferred that sinus membrane perforation and bleeding deriving
from injuries to the alveolar-antral artery are the main intraoperative complications
occurring during LASFE. High-quality RCTs focusing on the intraoperative
complications are needed to fully elucidate the critical steps of the intervention
and to suggest the more predictable surgical approach to the clinicians.

97
Table 5. 11: Critical appraisal of Stacchi et al (2017) using CASP tool (2018)

Intra-operative Complications During sinus floor elevation with lateral approach: A systematic Review
(Stacchi et al, 2017).
Did the study Yes, to analyse the occurrence of intraoperative complications during sinus floor elevation
address clearly with a lateral approach and their correlations with the technique adopted by surgeons.
focus question? Population- Patients requiring LASFE
Intervention – Lateral approach for Sinus elevation.

Comparator- Conventional rotary instruments or lateral antrostomy.

Outcome - Intraoperative complications.

Did the authors use Electronic and manual searches resulted in 4,417 records on sinus floor elevation. Twenty-
an appropriate type one randomized clinical trials (RCTs) and 11 prospective controlled clinical trials (CCTs)
of papers? reporting occurrence of intraoperative complications were included.
Were all the studies Yes, thorough explanation of inclusion and exclusion criterions were given. Three
included relevant electronic databases were searched for articles relevant in the context of this systematic
and important? review: National Library of Medicine (MEDLINE—PubMed), Embase, Cochrane Library
and Web of Science. Only human studies that too in English language. A detailed protocol
was developed and agreed upon by the authors.
Was the quality of Yes, Data was assessed by two reviewers. Any conflict was solved out by rest of the
the included contributors. Inclusions and their characteristics have been stated in Table 2.
studies assessed .
thoroughly by the
authors?
Were the results of Yes. Tabulated results have been stated for every demanded aspect of study.
the study
combined, was it
reasonable to do
so?
Results 15.7% occurrence of sinus membrane perforation and 0.4% of haemorrhagic events
following vascular lesions were the only intraoperative complications reported by the
selected studies. Among three different surgical devices (rotary instruments, piezoelectric
osteotomes, and manual bone scrapers) were used to perform the lateral antrostomy,
Ultrasonic devices and bone scrapers showed a lower incidence (10.9% and 6.0%,
respectively) of membrane perforation compared with that of rotary instruments (20.1%).
Among the different ultrasonic procedures, erosion of the lateral antral wall showed the
lowest membrane perforations (4.7% incidence). Haemorrhagic complications were found
to be infrequent with any surgical technique.

98
 Can the results Yes, the results can be applied locally and globally as per easy access of materials and
be applied to the techniques. Simple inclusion and exclusion criteria have been stated. Age group between
local population? 18 years to 80 years of age has been taken in account.
Were all important Yes, all important outcomes related to lateral maxillary sinus augmentation.
outcomes
considered?
Are the benefits Sinus membrane perforation being the most frequent intraoperative complication during
worth the harm and sinus floor elevation with a lateral approach, thinning the lateral wall of the sinus before
costs? performing the antrostomy (either with ultrasonic devices or manual bone scrapers) was
found to be an important factor in preventing membrane perforation during surgery.

99
 Table 5. 12: Critical appraisal of Stacchi et al (2017) using AMSTAR-2 tool (2017)

Intra-operative Complications During sinus floor elevation with lateral approach: A systematic Review
(Stacchi et al, 2017).
Did the research question Yes, to analyse the occurrence of intraoperative complications during sinus floor
and inclusion criteria include elevation with a lateral approach and their correlations with the technique
the components of PICO? adopted by surgeons.
Population- Patients requiring LASFE
Intervention – Lateral approach of sinus elevation
Comparator- Conventional rotary instruments or lateral antrostomy
Outcome - Intraoperative complications
Did the report of the review Partial Yes. A clearly focused question was present, search strategy was well
contain explicit statement defined. Inclusion and exclusion criteria were also well defined. There was no
that the review methods deviation from the inclusion or exclusion criteria during the screening process by
were established prior to the the authors. Risk of bias assessment was carried out of the included publications
conduct of the review? in the study and graded as low, moderate, or high.
Did the review authors Yes, Screening was done by two reviewers.
explain their selection of the Four electronic databases: The PubMed, Embase and Scopus databases were
study designs for inclusion in screened for articles. protocols and main outcomes of included studies are
their review? mentioned in table 2.
Comprehensive literature Partial Yes. Keywords and search strategy have been described and mentioned
search strategy? well in the review. No language restriction was applied, to limit the selection of
bias.
Did the review authors Yes. Detail electronic search was conducted by two independent authors (F.A.
perform study selection in and F.B.), who screened in duplicate, the PubMed, Embase and Scopus
duplicate? selecting article published from 1980 up to the latest access on February 18,
2014.Manual searches were also done.
Did the review authors Yes. Two blinded independent authors (F.A and C.S) performed, in duplicate.
performed data extraction in Intra-examiner reliability in the study selection process was assessed using the
duplicate? Cohen’s κ test. Conflicts were resolved by discussion of each article until
reaching consensus. Corresponding authors were contacted to retrieve any
missing information or clarification of specific items in the included studies.
Did the review authors Yes. Reasons of exclusion were precise and to the point. Studies with the lowest
provide a list of excluded quality within the hierarchy of scientific evidence such as (expert opinions, case
reports, case series, retrospective studies) were excluded. Further exclusion

100
 studies and justify the criteria were off topic; ex vivo, in vitro, animal studies; trans-crestal or alternative
exclusions? surgical accesses; expert opinions, case reports, case series, retrospective
studies, and prospective studies with less than 15 sinus augmentations;
antrostomy technique not clearly described; no clear mention
of intraoperative complications; inlay block grafts and inexperienced surgeons.
Did the authors described Yes. Characteristics and outcomes of included criterion mentioned in table 2.
the included studies in
detail?
Did the review authors use a Yes. Two authors independently determined the risk of
satisfactory technique for bias of each study included in the final selection using the Cochrane
assessing the risk of bias Collaboration's tool for assessing risk of bias in randomized clinical, regarding all
(RoB)? the other study designs (or RCTs where intraoperative complications were not
among the primary outcomes), modified Downs and Black checklist consisting of
19 items (Table 1), was used to assess the risk of bias of all the other controlled
clinical trials (CCTs).
Did the review authors report This study received no external funding.
on the sources of funding for
the studies included in the
review?
If meta-analysis was No meta-analysis was conducted.
performed did the review
authors use appropriate
methods for statistical
combination of results?
If meta-analysis was No meta-analysis was conducted.
performed, did the review
authors assess the potential
impact of RoB in individual
studies on the results of the
meta-analysis or other
evidence synthesis?
Did the review authors Yes. Detailed information on the risk of bias in individual studies is reported in
account for RoB in individual Tables 3 and 4. From the assessment performed with Cochrane Collaboration’s
studies when interpreting/ tool,5 RCTs were shown to be at a high risk of bias, with 2 RCTs showing an
discussing the results of the unclear risk of bias while 6 RCTs did not show a significant risk of bias.
review?
Did the review authors Yes. The authors did discuss the variation. Age difference ranged in from 18
provide a satisfactory years to 80 years.
explanation for, and
discussion of, any

101
heterogeneity observed in
the results of the review?

If they performed Partially Yes.

quantitative synthesis did the
review authors carry out an
adequate investigation of
publication bias (small study
bias) and discuss its likely
impact on the results of the
review?
Did the review authors report No. The authors report no conflicts of interest related to this study nor any
any potential sources of received funding was reported by the authors.
conflict of interest, including
any funding they received?
for conducting the review?

102
Table 5. 13: Critical appraisal of Stacchi et al (2017) using ROBIS tool
(2016)

Phase 1:

Category Target Question (Overview or guideline)

Population(s) Patients requiring LASFE

Intervention(s) Lateral Approach for Sinus Elevation

Comparator(s) Conventional rotary instruments or lateral antrostomy

Outcome(s) Intraoperative complications

Does the question address by the review YES

matched the target question?

Summary of Domain 1:
The study was conducted analyze the clinical complications of LASFE
(intraoperative and postoperative complication) and its correlation with other
techniques adopted by surgeons. The eligibility criteria comprised of including
only human clinical trials mainly randomized controlled trials though there was no
language barrier. The screening and selection were done with the help of two
reviewers and if they two got uncertain over the inclusion of an article then other
authors were engaged for consensus. Initial screening was by title and then by
abstract. The reviewers electronically and manually searched out the articles.

103
Phase 2: Identifying concerns with the review process
DOMAIN 1: STUDY ELIGIBILITY CRITERIA

1.1 Did the review adhere to pre-defined objectives and eligibility criteria? YES
1.2 Were the eligibility criteria appropriate for the review question? YES
1.3 Were eligibility criteria unambiguous? YES
1.4 Were any restrictions in eligibility criteria based on study YES
characteristics appropriate (e.g. date, sample size, study quality,
outcomes measured)?
1.5 Were any restrictions in eligibility criteria based on sources of NO
information appropriate (e.g. publication status or format, language,
availability of data)?
Concerns regarding specification of study eligibility criteria UNCLEAR

Summary of domain 2:
Computer search of electronic databases: The PubMed, Embase and Scopus
databases were screened for articles published from 1980 up to the latest access
on February 18, 2014. was done to generate articles relevant to the research
question. Certain keywords: hemorrhagic complications, intraoperative
complications, membrane perforation, sinus floor elevation were used to make
the search reliable and relevant. Search was limited till 2017.

104
 DOMAIN 2: IDENTIFICATION AND SELECTION OF STUDIES

2.1 Did the search include an appropriate range of databases/electronic YES

sources for published and unpublished reports?
2.2 Were methods additional to database searching used to identify YES
relevant reports?
2.3 Were the terms and structure of the search strategy likely to retrieve YES
as many eligible studies as possible?
2.4 Were restrictions based on date, publication format, or language YES
appropriate?
2.5 Were efforts made to minimize error in selection of studies? YES
Concerns regarding methods used to identify and/or select studies LOW

Summary of domain 3:
In the study, data extraction was also conducted by two reviewers hence
reducing the risk of bias. Characteristics of the included studies are presented in
Table 2., Two authors independently determined the risk of bias of each study
included in the final selection using the Cochrane Collaboration's tool for
assessing risk of bias in randomized clinical Trials. Random sequence
generation, Allocation concealment, blinding of participants and personnel;
Blinding of outcome assessment; Incomplete outcome data; Selective reporting
identical treatment group and report of follow up. Modified Downs and Black
checklist consisting of 19 items (Table 1), was used to assess the risk of bias of
all the other controlled clinical trials (CCTs).

105
DOMAIN 3: DATA COLLECTION AND STUDY APPRAISAL

3.1 Were efforts made to minimize error in data collection? YES

3.2 Were sufficient study characteristics available for both review authors YES
and readers to be able to interpret the results?
3.3 Were all relevant study results collected for use in the synthesis? YES
3.4 Was risk of bias (or methodological quality) formally assessed using YES
appropriate criteria?
3.5 Were efforts made to minimize error in risk of bias assessment? YES

Concerns regarding methods used to collect data and appraise studies LOW

Summary of domain 4:
No Meta-analysis was. The Biases in the studies were mentioned in the article,
according to the Cochrane Collaboration's tool and Modified Downs and Black
checklist for assessing risk of bias, the synthesis included all the studies and the
outcome under evaluation was highlighted in all the publications.
DOMAIN 4: SYNTHESIS AND FINDINGS

4.1 Did the synthesis include all studies that it should? YES
4.2 Were all pre-defined analyses reported or departures explained? YES
4.3 Was the synthesis appropriate given the nature and similarity in YES
the research questions, study designs and outcomes across
included studies?
4.4 Was between-study variation (heterogeneity) minimal or YES
addressed in the synthesis?
4.5 Were the findings robust, e.g. as demonstrated through funnel YES
plot or sensitivity analyses?
4.6 Were biases in primary studies minimal or addressed in the YES
synthesis?
Concerns regarding the synthesis and findings LOW

106
Phase 3: Judging risk of bias

Summarize the concerns identified during the Phase 2 assessment:

Domain Concern Rationale for concern

The study has a focused question, the eligibility criteria and specifications have been mentioned
along with the outcome which is - Intraoperative complications following sinus elevation by
1. UNCLEAR lateral approach.

Search strategy has been clearly mentioned by the author, keywords and mesh terms have
been mentioned along with the language of the articles that need to be retrieved (any language)
making the concern in this domain. Three reliable databases were used PubMed, EMBASE and
2. LOW SCOPUS reference lists of included articles were also screened by two reviewers.

The data extraction was done by two reviewers thereby minimizing bias. The authors have
displayed the characteristics of the included articles in a tabulated form in the article. Risk of
3. LOW bias of the included studies was also assessed.

The synthesis and findings are clearly illustrated in a tabulated form in the publication by the
4. LOW authors, constituting of type of study control and test group along with the results and P-value.

RISK OF BIAS IN THE REVIEW

A. Did the interpretation of findings address all the concerns YES

identified in Domains 1 to 4?
B. Was the relevance of identified studies to the review's research YES
question appropriately considered?
C. Did the reviewers avoid emphasizing results based on their YES
statistical significance?
Risk of bias in the review RISK: LOW

107
Summary of the article: Piezoelectric bone surgery for lateral sinus floor
elevation compared with conventional rotary instruments: a systematic review,
meta-analysis and trial sequential analysis (Stacchi et al, 2020)

Author’s aim of the present systematic review, meta-analysis and trial sequential
analysis (TSA) was to analyze the clinical outcomes of LASFE (intraoperative and
postoperative complications, surgical time and implant survival rate), comparing
the PBS with the use of conventional rotary instruments. When residual bone
height is not sufficient for implant placement, but inter-arch relationships are
preserved, sinus floor elevation with lateral approach (LASFE) is regenerative
option derived from Caldwell-Luc approach to re-establish adequate crestal height
to place an implant. A bony window is made in the cavity, membrane is lifted,
walls are curettage. Space ifs grafted with autogenous bone graft or autografts to
allow insertion of implants of desired lengths.

Rotary instruments are used to perform antrostomy and are associated with
membrane perforation risks. The mean difference between the two procedures
was 3.43 minutes, significantly favoring the control group There was weak
evidence suggesting that
there is no difference in membrane perforation risk between piezoelectric surgery
and rotary instruments. Four electronic databases were searched for articles
relevant in the context of this systematic review: National Library of Medicine
(MEDLINE—PubMed), Embase, Cochrane Library and Web of Science. Only
human studies were included with no language specifications or restrictions. The
study received no external funding. Two reviewers screened the articles. Any
disagreement in the final selection was resolved by open discussion between both
reviewers. In the case that no agreement could be reached, the other co-author
acted as arbiter. Characteristics of included studies were illustrated in tables and
flow charts. Meta-Analysis was conducted. The statistical data reliability in the
meta-analysis was quantified by means of TSA.

108
The power of the evidence was too weak to confirm the mentioned findings and
further well-designed randomized clinical trials are needed to draw definitive
conclusions. Hence concluded that moderate evidence suggested perforation
comparison between the two procedure, Moderate evidence suggested duration
of surgery differences among the two and insufficient data accessibility in accord
with survival rate of implants.

109
110
Table 5. 14: Critical appraisal of Stacchi et al (2020) using CASP tool (2018).
Piezoelectric bone surgery for lateral sinus floor elevation compared with conventional rotary
instruments: a systematic review, meta-analysis and trial sequential analysis (Stacchi et al, 2020)
Did the study Yes, present systematic review aimed to answer was: “Does PBS for lateral maxillary
address clearly sinus floor elevation reduce risk of intraoperative complications, require prolonged
focus question? surgical time and improve the survival rate of dental implants compared with conventional
rotary instruments?’’
Population- Patients requiring LASFE to allow dental implants placement
Intervention - PBS for lateral antrostomy

Comparator- Conventional rotary instruments or lateral antrostomy

Outcome - Intraoperative complications, implant failure, surgical time.

Did the authors use The selection criteria included randomized controlled trials (RCTs) and case-control
an appropriate type studies (CCTs) comparing PBS with rotary instruments in lateral sinus augmentation and
of papers? reporting intraoperative and postoperative outcomes (e.g. sinus membrane perforations,
surgical time and implant failure rate). Four RCTs met the inclusion criteria and were
included in the review
Were all the studies Yes, thorough explanation of inclusion and exclusion criterions were given. Three
included relevant electronic databases were searched for articles relevant in the context of this systematic
and important? review: National Library of Medicine (MEDLINE—PubMed), Embase, Cochrane Library
and Web of Science. Only human studies that too in English language. A detailed protocol
was developed and agreed upon by the authors.
Was the quality of Yes, Data was assessed by two reviewers. Any conflict was solved out by rest of the
the included contributors.
studies assessed .
thoroughly by the
authors?
Were the results of Yes. Tabulated results have been stated for every demanded aspect of study.
the study
combined, was it
reasonable to do
so?
Results There was weak evidence suggesting that there is no difference in membrane perforation
risk between piezoelectric surgery and rotary instruments; moderate data suggesting
surgery’s duration and insufficient data on the survival rate of implants at the site.
Can the results Yes, the results can be applied locally and globally as per easy access of materials and
be applied to the techniques. However financial suitability would be held in account as per patient’s
local population? affordability. Simple inclusion and exclusion criteria have been stated. No age group
limitation has been stated.

111
Were all important Yes, all important outcomes related to lateral maxillary sinus augmentation have been
outcomes addressed.
considered?
Are the benefits Implants inserted after LASFE exhibited satisfactory clinical outcomes,95% survival rate
worth the harm and after 5 years or more of loading.
costs?

112
 Table 5. 15: Critical appraisal of Stacchi et al (2020) using AMSTAR-2 tool (2017)

Piezoelectric bone surgery for lateral sinus floor elevation compared with conventional rotary
instruments: a systematic review, meta-analysis and trial sequential analysis (Stacchi et al, 2020)
Did the research question Yes, present systematic review aimed to answer was: “Does PBS for lateral
and inclusion criteria include maxillary sinus floor elevation reduce risk of intraoperative complications, require
the components of PICO? prolonged surgical time and improve the survival rate of dental implants
compared with conventional rotary instruments?’’
Population- Patients requiring LASFE to allow dental implants placement
Intervention - PBS for lateral antrostomy
Comparator- Conventional rotary instruments or lateral antrostomy
Outcome - Intraoperative complications, implant failure, surgical time.
Did the report of the review Partial Yes. A clearly focused question was present, search strategy was well
contain explicit statement defined. Inclusion and exclusion criteria were also well defined. There was no
that the review methods deviation from the inclusion or exclusion criteria during the screening process by
were established prior to the the authors. Risk of bias assessment was carried out of the included publications
conduct of the review? in the study and graded as low, moderate, or high. Meta-analysis was conducted.
Did the review authors Yes, Screening was done by two reviewers.
explain their selection of the Four electronic databases: The PubMed, Embase, Scopus and Open Grey
study designs for inclusion in databases were screened for articles.
their review?
Comprehensive literature Partial Yes. Keywords and search strategy have been described and mentioned
search strategy? well in the review. No language restriction was applied, to limit the selection of
bias.
Did the review authors Yes. Thorough electronic search was conducted by two independent authors (A.
perform study selection in R. and A. E.), who sscreened in duplicate, the PubMed, Embase, Scopus and
duplicate? Open Grey databases from 1 January 1990 to the latest entry on 31 December
2018.
Did the review authors Yes. Two blinded independent authors (F. B. and G. T.) performed, in duplicate.
performed data extraction in Intra-examiner reliability in the study selection process was assessed using the
duplicate? Cohen’s κ test. Conflicts were resolved by discussion of each article until
reaching consensus. Corresponding authors were contacted to retrieve any
missing information or clarification of specific items in the included studies.
Did the review authors Partially Yes. Reasons of exclusion were precise and to the point .Mentioned in
provide a list of excluded Table 1.

113
 studies and justify the
exclusions?

Did the authors described Yes. Randomised controlled trials (RCTs) and case-control studies (CCTs) (≥ 10
the included studies in patients/group) comparing the PBS with conventional rotary instruments in lateral
detail? sinus augmentation and reporting intraoperative and postoperative outcomes
(e.g. sinus membrane perforations, bleeding events, surgical time and implant
failure rate) for both groups were included. Full texts of the selected papers were
examined following the inclusion and exclusion criteria. Characteristics included
in table 2.
Did the review authors use a Yes. Two authors independently determined the risk of
satisfactory technique for bias of each study included in the final selection using the Cochrane
assessing the risk of bias Collaboration's tool for assessing risk of bias in randomized clinical.
(RoB)? Trials. Random sequence generation, Allocation concealment, Blinding of
participants and personnel; Blinding of outcome assessment; Incomplete
outcome data; Selective reporting.
Did the review authors report This study received no external funding.
on the sources of funding for
the studies included in the
review?
If meta-analysis was Yes, meta-analysis was conducted. The present meta-analysis adopted strict
performed did the review inclusion criteria for study selection (only prospective studies
authors use appropriate
with a control group), and the statistical data reliability in the meta-analysis
methods for statistical
was quantified by means of TSA (taking into consideration type 1 and 2
combination of results?
errors).
If meta-analysis was Yes-metal analysis conducted.
performed, did the review This meta-analysis followed PRISMA guidelines and was registered in
authors assess the potential the PROSPERO database (CRD42019122972).
impact of RoB in individual
studies on the results of the
meta-analysis or other
evidence synthesis?
Did the review authors Yes. The risk of bias assessment was performed using the Cochrane
account for RoB in individual Collaboration’s tool for RCTs by two reviewers (C.S. and F.B.) independently.
studies when interpreting/ Sources were classified as high risk, low and unclear accordingly. Heterogeneity
discussing the results of the was assessed using the χ2-based Q-statistic method with a significant P value <
review? 0.05. I2 index was also reported due to relative insensitivity.

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Did the review authors Yes. The authors did discuss the variation. The meta-analysis
provide a satisfactory showed that, although a lower incidence of membrane tearing occurred when
explanation for, and using PBS, the difference between the two groups was not significant.
discussion of, any
heterogeneity observed in
the results of the review?
If they performed Partially Yes.
quantitative synthesis did the
review authors carry out an
adequate investigation of
publication bias (small study
bias) and discuss its likely
impact on the results of the
review?
Did the review authors report No. The authors report no conflicts of interest related to this study nor any
any potential sources of received funding was reported by the authors.
conflict of interest, including
any funding they received?
for conducting the review?

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Table 5. 4: Critical appraisal of Stacchi et al (2020) using ROBIS tool (2016)

Phase 1:

Category Target Question (Overview or guideline)

Population(s) Patients requiring LASFE to allow dental implants placement

Intervention(s) PBS for lateral antrostomy

Comparator(s) Conventional rotary instruments or lateral antrostomy

Outcome(s) Intraoperative complications, implant failure, surgical time.

Does the question address by the review YES

matched the target question?

Summary of Domain 1:
The study was conducted analyze the clinical outcomes of LASFE (intraoperative and
postoperative complications, surgical time and implant survival rate), comparing the PBS
with the use of conventional rotary instruments. The eligibility criteria comprised of
including only human clinical trials mainly randomized controlled trials though
there was no language restriction. The screening and selection were done with
the help of two reviewers and if they two got uncertain over the inclusion of an
article then other authors were engaged for consensus. Initial screening was by
title and then by abstract. The reviewers electronically searched out the articles.

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Phase 2: Identifying concerns with the review process
DOMAIN 1: STUDY ELIGIBILITY CRITERIA

1.1 Did the review adhere to pre-defined objectives and eligibility criteria? YES
1.2 Were the eligibility criteria appropriate for the review question? YES
1.3 Were eligibility criteria unambiguous? NO
1.4 Were any restrictions in eligibility criteria based on study YES
characteristics appropriate (e.g. date, sample size, study quality,
outcomes measured)?
1.5 Were any restrictions in eligibility criteria based on sources of NO
information appropriate (e.g. publication status or format, language,
availability of data)?
Concerns regarding specification of study eligibility criteria UNCLEAR

Summary of domain 2:
Computer search of electronic databases: The PubMed, Embase, Scopus and
Open Grey databases were screened for articles published from 1 January 1990
to 31 December 2018. was done to generate articles relevant to the research
question. Certain keywords: Intraoperative complications, membrane perforation,
piezosurgery, sinus floor elevation was used to make the search reliable and
relevant. Search was limited till 2018.

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 DOMAIN 2: IDENTIFICATION AND SELECTION OF STUDIES

2.1 Did the search include an appropriate range of databases/electronic YES

sources for published and unpublished reports?
2.2 Were methods additional to database searching used to identify YES
relevant reports?
2.3 Were the terms and structure of the search strategy likely to retrieve YES
as many eligible studies as possible?
2.4 Were restrictions based on date, publication format, or language YES
appropriate?
2.5 Were efforts made to minimize error in selection of studies? YES
Concerns regarding methods used to identify and/or select studies LOW

Summary of domain 3:
In the study, data extraction was also conducted by two reviewers hence
reducing the risk of bias. Characteristics of the included studies are presented in
Table 2., Two authors independently determined the risk of bias of each study
included in the final selection using the Cochrane Collaboration's tool for
assessing risk of bias in randomized clinical Trials. Random sequence
generation, Allocation concealment, blinding of participants and personnel;
Blinding of outcome assessment; Incomplete outcome data; Selective reporting
identical treatment group and report of follow up., “Low risk” if all the stated
criteria were met, “Unclear risk” if at least one criteria were not met, “high risk” if
two or more criteria were not met.

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DOMAIN 3: DATA COLLECTION AND STUDY APPRAISAL

3.1 Were efforts made to minimize error in data collection? YES

3.2 Were sufficient study characteristics available for both review authors NO
and readers to be able to interpret the results?
3.3 Were all relevant study results collected for use in the synthesis? YES
3.4 Was risk of bias (or methodological quality) formally assessed using YES
appropriate criteria?
3.5 Were efforts made to minimize error in risk of bias assessment? YES

Concerns regarding methods used to collect data and appraise studies UNCLEAR

Summary of domain 4:
Meta-analysis was conducted Statistical heterogeneity was assessed by
calculation of the Q statistic. I2 index was also reported due to relative
insensitivity. The Biases in the studies were mentioned in the article, according to
the Cochrane Collaboration's tool for assessing risk of bias, “low risk” if all the
stated criteria were complied, “Unclear risk” if at least one criteria were not
complied, “high risk” if two or more items were not complied. The synthesis
included all the studies and the outcome under evaluation was highlighted in all
the publications however, some studies showed statistically significant difference
among the control and test group whereas some showed no difference. The
power of the evidences was too weak to confirm the mentioned findings and
further well-designed randomized clinical trials are needed to draw definitive
conclusions.

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DOMAIN 4: SYNTHESIS AND FINDINGS

4.1 Did the synthesis include all studies that it should? NO

4.2 Were all pre-defined analyses reported or departures explained? NO
4.3 Was the synthesis appropriate given the nature and similarity in YES
the research questions, study designs and outcomes across
included studies?
4.4 Was between-study variation (heterogeneity) minimal or YES
addressed in the synthesis?
4.5 Were the findings robust, e.g. as demonstrated through funnel YES
plot or sensitivity analyses?
4.6 Were biases in primary studies minimal or addressed in the YES
synthesis?
Concerns regarding the synthesis and findings HIGH

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Phase 3: Judging risk of bias

Summarize the concerns identified during the Phase 2 assessment:

Domain Concern Rationale for concern

The study has a focused question, the eligibility criteria and specifications have been mentioned
along with the outcome which is - Intraoperative complications, implant failure, surgical time.
1. UNCLEAR Weak evidence and insufficient data have been supported in referral to the outcomes.

Search strategy has been clearly mentioned by the author, keywords and mesh terms have
been mentioned along with the language of the articles that need to be retrieved (English
language) making the concern in this domain. Three reliable databases were used PubMed,
EMBASE,SCOPUS and Open Gray, reference lists of included articles were also screened by
2. LOW two reviewers.

The data extraction was done by two reviewers thereby minimizing bias. The authors have
displayed the characteristics of the included articles in a tabulated form in the article. Risk of
bias of the included studies was also assessed but the relevant data was insufficient. Hence
3. UNCLEAR making the bias unclear.

The synthesis and findings are clearly illustrated in a tabulated form in the publication by the
4. HIGH authors, constituting of type of study control and test group along with the results and P-value.

RISK OF BIAS IN THE REVIEW

A. Did the interpretation of findings address all the concerns NO

identified in Domains 1 to 4?
B. Was the relevance of identified studies to the review's research YES
question appropriately considered?
C. Did the reviewers avoid emphasizing results based on their YES
statistical significance?
Risk of bias in the review RISK: UNCLEAR

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5.2 Qualitative Analysis of Results

For the purpose of this analysis, the studies have been assigned unique
study numbers as follows.
Study Authors
Number
1 Atieh et al., 2015
2 Geminiani et al.,
2017
3 Jordi et al., 2018
4 Staachi et al., 2017
5 Staachi et al., 2020

5.2.1 Primary Outcomes

5.2.1.1Sinus Membrane Perforation Rate

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123
124
5.2.1.2 Operating Time

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126
6. Discussion

visible under a thin layer of bone outlining the window. In this way, the risk of
perforating the membrane is minimized (Staachi et al., 2017). Thus, PEDs are

127
well-suited for this surgery with a possible decreased chance of damaging the
membrane.
PEDs do have the disadvantage of taking a longer duration for the surgery, taking
up to five time longer than conventional surgical drills ( Atieh et al., 2015).

5.2 Sinus Membrane Perforation

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RCTs to analyze and a consequent small data. However, Jordi et al. decided to
include other study designs as well. As a result, 22 RS and 32 PS were included,
in addition to nine RCTs. Although the heterogeneity of the data was high and the
quality of the studies was generally low, a large amount of data became available
to be included in the meta-analysis (Jordi et al., 2018).
No meta-analysis was conducted in study 4 by Staachi et al., 2017. In study 5
Staachi et al. conducted a meta-analysis on data from four RCTs. However, the
findings did not report any significant difference in the membrane perforation rates
between PEDs and rotary instruments used for LASFE. Since, high-quality RCTS
were selected for the meta-analysis, no heterogeneity was found. Staachi et al.
also conducted a trial sequential analysis. As per the analysis, a required
information size of 2034 interventions were needed for the meta-analysis to have
80% power. However, the conducted meta-analysis only included 143
interventions and thus the analysis was under-powered (Staachi et al., 2020).
Except for one, none of the included RCTs in all the reviews did not specify the
exact stage of the surgery at which the perforation occurred. This is a critical
information, since the perforation of the membrane during elevation or bone
grafting is independent from either the use of PED or conventional burs as
potentially other factors would be responsible for it. A total of four studies reported
the exact timing of the perforations (one RCT, one case-control RS, two PS). A
total of 14 perforations were reported in these four studies. The presentation of
these perforations has been shown in table 6.1.

As shown, most of the perforations occurred during the ‘manual elevation stage’
of the surgery – a time where neither the PED nor the rotary burs are being used.

129
This means that it is the clinical competence of the surgeon and not the properties
of the device that may have led to the sinus membrane perforation. Due to lack of
reported timings of the perforations in the majority of the studies, it is difficult to
present a deductive finding. Future trials should report the timing of the
perforations so as to ascertain whether the use of either the PEDs or rotary
instruments have played a potential in the occurrence of sinus membrane
disruption.

5.3 Operating Time

130
trephine was included. In fact, only four (three RCTs and one RS) of the included
11 studies compared PEDs. Therefore, these meta-analysis findings do not
completely reflect only a comparison between rotary instruments and PEDs
(Geminiani et al., 2017).

6.3 Hemorrhagic Events

Only one study reported the incidence of hemorrhagic events to be 0.4% (Staachi
et al., 2017). No comparison between different techniques was reported.
Although, LASFE procedures done using PEDs are expected to have fewer
hemorrhagic events, in comparison to the use of rotary instruments, no conclusive
evidence could be ascertained from the included reviews.

131
6.4 Sinus and/or Wound Infections

6.5 Implant Failure Rate

In study 1 by Atieh et al, only two RCTs reported the implant failure rate. No
significant difference in the failure rate was found for implants for which LASFE

132
had been performed using PEDs, when compared with conventional rotary
instruments (RR = 0.20; 95% CI = 0.02, 1.65; p < 0.14) (Atieh et al., 2015).
Similarly, only one RCT reported implant failure rate in study 5, with no
significant difference reported, since the implants had all a 100% success rate
(Staachi et al., 2020). Due to lack of data (small sample and missing information
on implant failure), it was not possible to draw any conclusion regarding the
effectiveness of using PEDs, in comparison to rotary instruments for LASFE in
terms of long-term implant success.

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6.6 Quality of Evidence

134
6.7 Limitations

6 Conclusions

7.1 Implications for Practice

The overall findings of the systematic reviews were insufficient to suggest if
LASFE procedures performed using PEDs had better outcomes, in terms of
intraoperative and postoperative complications, when compared to conventional
rotary instruments. Although the difference in the sinus membrane perforation
rates between the two groups (PEDs and rotary instruments) in high-quality
studies was not found to be statistically significant, these differences in the
incidence rates may suggest a sort of clinical guidance in terms of a lower
occurrence of this intraoperative complication using PEDs support rather than
rotatory instruments.

135
On the contrary LASFE, procedures done by using PEDs took more operating
time than those done using rotatory instruments, However, this difference was not
of much clinical importance albeit it had a statistically significant value.
Finally, no evidence regarding the long-term success of placing implants following
LASFE procedures done using PEDs, as compared with rotatory instruments was
available.

7.2 Implications for Research

136
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