Implant Mandibular Overdentures Retained by

Immediately Loaded Implants: A 1-Year Randomized Trial

Comparing Patient-Based Outcomes Between
Mini Dental Implants and Standard-Sized Implants
Kostas Zygogiannis, DDS, PhD1/Irene H.A. Aartman, PhD2/Daniel Wismeijer, DDS, PhD3

Purpose: The aim of this 1-year randomized trial was to determine the stability and the magnitude of the effect of
converting patients’ conventional mandibular dentures to implant overdentures (IODs) on their satisfaction and oral
health–related quality of life (OHRQoL). The IODs were retained either with two immediately loaded interconnected
standard-diameter implants or with four immediately loaded mini dental implants (MDIs). Materials and Methods:
Fifty completely edentulous subjects complaining about insufficient retention of their mandibular dentures were
randomly assigned to two groups; 25 patients received IODs retained with four MDIs and 25 patients received IODs
retained with two standard-sized tissue level (STL) interconnected implants. All IODs were opposed by conventional
maxillary dentures. Patients rated their satisfaction on a 100-mm visual analog scale (VAS) and their quality of
life on a denture-specific short version of the oral health impact profile (OHIP-20) before assignment, and after 3
and 12 months. A two-way mixed analysis of variance (ANOVA) was conducted to assess the change in time and
its interaction with treatment mode on patients’ overall satisfaction ratings, the total OHIP-20, and their specific
domain scores. Results: Immediate loading was possible for all the patients who received the MDIs. By contrast,
the immediate loading protocol could be followed for only 15 of the patients allocated to the STL implant group. For
the remaining patients, a delayed loading protocol was applied. There was a significant improvement in patients’
general satisfaction between baseline and 3 months and between baseline and 12 months postoperatively
(F2,44 = 81.006, P < .001). This increase did not differ between the treatment groups (F4,90 = 1.838, P = .128).
The results also showed a decrease in mean overall OHIP score (F2,43 = 46.863, P < .001) between baseline and
3 months and between baseline and 12 months postoperatively, indicating a higher level of OHRQoL. In addition,
patients scored lower 3 and 12 months after treatment than at baseline for all seven domains. This decrease
did not differ between the treatment groups (F4,88 = 0.608, P = .658). Conclusion: The results suggested that in
terms of patient-based outcomes, mandibular overdentures retained by immediately loaded MDIs can offer an
improvement of equal magnitude with that achieved by overdentures retained by standard-sized implants. Int J
Oral Maxillofac Implants 2018;33:197–205. doi: 10.11607/jomi.6009

Keywords: immediate loading, mini dental implants, OHIP-20, VAS

1 Assistant Professor, Department of Oral Implantology and

Prosthetic Dentistry, Academic Centre for Dentistry Amsterdam
(ACTA), University of Amsterdam and Vrije Universiteit Amsterdam,
Amsterdam, The Netherlands.
2Senior Lecturer, Department of Social Dentistry, Academic Centre
for Dentistry Amsterdam (ACTA), University of Amsterdam and
Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
3 Professor, Department of Oral Implantology and Prosthetic
Dentistry, Academic Centre for Dentistry Amsterdam (ACTA),
University of Amsterdam and Vrije Universiteit Amsterdam,
Amsterdam, The Netherlands.
Correspondence to: Dr Kostas Zygogiannis, Department of Oral
Implantology and Prosthetic Dentistry, Academic Centre for
Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije
Universiteit Amsterdam, Gustav Mahlerlaan 3004, 1081 LA
Amsterdam, The Netherlands. Fax: +31(0)205980333.
Email: k.zygogiannis@acta.nl
©2018 by Quintessence Publishing Co Inc.
T he immediate loading concept in completely eden-
tulous patients in need of mandibular implant
overdentures (IODs) is considered a viable treatment
option.1 The proposed advantages of such protocols
are a reduction in the number of surgical and prosth-
odontic procedures, associated clinical time, healing
periods, and treatment costs. Initially, the use of four
splinted implants was considered mandatory to obtain
long-term favorable results.2 More recent studies on
the immediate loading of two implants with an over-
denture have also shown promising results.3,4 However,
a limitation of immediate loading treatment protocols
has been the diameter of the implants. Also, in cases
where the residual bone width is limited, patients still
need to undergo a bone augmentation procedure be-
fore standard-sized implants can be inserted.5

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Zygogiannis et al
An alternative to standard-diameter implants in
the edentulous mandible is the use of mini dental im-
plants (MDIs). The MDI is a one-piece implant that does
not require a separate abutment. This simplifies the re-
storative phase, resulting in reduced costs for the pa-
tient. Several studies have advocated the use of MDIs
to support mandibular overdentures, indicating favor-
able clinical and radiographic outcomes.6,7 The narrow
diameter of the MDIs often allows a simplified inser-
tion technique involving placement without raising a
flap.8 There is, however, a lack of randomized studies
comparing immediately loaded MDIs and standard-
sized implants retaining mandibular overdentures
in adult edentulous patients.9 A recently published
randomized trial compared mandibular overdentures
retained by either MDIs (four or two) or two standard-
sized implants. In this trial, however, a delayed loading
protocol was followed.10
Beyond clinical findings, patients’ acceptability and
perception of how implant treatment contributes to
their oral health–related quality of life (OHRQoL) and
overall satisfaction are also important factors that affect
the overall success of IODs. For this purpose, general
satisfaction ratings on a visual analog scale (VAS) as well
as the oral health impact profile (OHIP) questionnaires
have been extensively used. It has been shown that a
denture-specific short version of the OHIP (OHIP-20)
possesses good psychometric properties, and is very
useful for clinical trials of oral prostheses.11,12 The eval-
uation of patients’ satisfaction with IODs retained by
immediately loaded MDIs has also shown positive re-
sults.13,14 Until now, however, there are no prospective
studies reporting on patients’ OHRQoL and satisfaction
levels with mandibular overdentures retained by im-
mediately loaded standard-sized implants or MDIs. The
aim of this 1-year randomized trial was to evaluate and
compare patients’ satisfaction and OHRQoL before and
after converting their conventional mandibular den-
tures to implant overdentures (IODs). The IODs were
retained either with two immediately loaded intercon-
nected standard-sized implants or with four immedi-
ately loaded MDIs.
MATERIALS AND METHODS
The study population consisted of 50 patients having
problems with the retention of their existing conven-
tional mandibular dentures. The study was conducted
in accordance with the Helsinki Declaration of 1975,
as revised in 2000. Ethical approval was obtained from
the local ethical review board (METc VUmc registration
number 2013/208, Amsterdam, the Netherlands). The
study was conducted at the Department of Oral Im-
plantology and Prosthetic Dentistry, Academic Centre
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for Dentistry Amsterdam (ACTA), University of Amster-
dam and Vrije Universiteit Amsterdam from Septem-
ber 2013 to September 2016. A number of patients
were recruited through internal referral at ACTA. These
were patients who were previously provided with con-
ventional dentures, and they experienced problems
with the retention of the mandibular denture. Patients
were also recruited following advertisements placed in
local newspapers circulated within the city of Amster-
dam, the Netherlands. All participants were treated in
a university-affiliated clinic.
Inclusion criteria dictated that the patient should
be completely edentulous for at least 6 months, had
a maladaptive mandibular denture, and had adequate
bone for an implant length of at least 10 mm and di-
ameter of at least 3.3 mm. The exclusion criteria were:
(1) patients who received radiotherapy to the head or
neck region for malignancies; (2) patients on long-term
steroids, immunosuppressants, or bisphosphonates;
(3) smokers; (4) patients with physical and mental dis-
abilities that interfere with the maintenance of im-
plants; and (5) systemic diseases precluding implant
surgery.
All patients signed informed consent and under-
went a clinical and radiographic examination. The
dentures were examined in the mouth for retention,
stability, esthetics, and phonetics. In cases where the
existing dentures were insufficient in terms of esthet-
ics, intermaxillary relationships, overextendedness, or
underextendedness, a new set of dentures was fab-
ricated first. In cases where the only inadequacy was
lack of retention of the mandibular denture, the exist-
ing ones were used.
The randomization sequence was generated using
a computer script (PHP), stratifying for sex and age.
The enrollment of the participants, all surgical and
prosthodontic treatments, as well as the postopera-
tive follow-up clinical examinations were performed
by the same clinician who was not blinded for the ran-
dom allocation sequence and the interventions (K.Z.).
Two groups of patients were formed: group 1, in which
the mandibular overdentures were retained by four
immediately loaded MDIs with an O-ring attachment
system; and group 2, in which the mandibular over-
dentures were retained by two immediately loaded
implants with a bar-and-clip attachment system.
It was not possible to apply the immediate loading
protocol for all patients in group 2. Therefore, these
patients were divided into two subgroups: group 2A
(immediate loading, n = 15) and group 2B (delayed
loading, n = 10). The number of new or existing con-
ventional dentures that were modified to IODs was
equally distributed in the groups (χ2 = 0.77, df = 2,
P = .682). In group 1, 14 out of the 25 patients received
new dentures prior to implant treatment, and in group

Recruited Assessed for eligibility
(n = 112)
•Did not meet inclusion criteria: n = 48
•Declined to participate: n = 14
Enrolled
Enrolled (n = 50)
Group 1 (4 MDIs): n = 25
Group 2 (2 Straumann implants): n = 25
1-yr follow-up
Lost to follow-up: n = 1 (Group 2)
Completed study: n = 49
•As planned: n = 49
•Stopped early, with reason: n = 0
Analyzed
Number of patients analyzed
(n = 49)
Fig 1   Flow diagram of participants in the study.
2, 15 out of 25 patients (8 patients in group 2A and 7 in
group 2B). The flow diagram of the study participants
is shown in Fig 1.
Sample Size Calculation
The main outcome of this 1-year randomized trial was
the marginal bone loss (MBL) around the inserted im-
plants. Secondary outcomes included the success and
survival rates, peri-implant soft tissue response, and
the prosthodontic complications. These outcomes
were presented in another article.15 The present ar-
ticle reports the patient-based outcomes. The sample
size calculation was, however, based on the expected
changes in the primary outcome (marginal bone loss)
between baseline and the 12-month follow-up.
Interventions
The patients rinsed with chlorhexidine digluconate
solution (0.2%) for 1 minute before the operation. No
prophylactic antibiotic regimen was used. The surgical
field was infiltrated with articaine (Ultracaine D-S Forte
Sanofi-Aventis Deutschland GmbH).
Group 1: Four MDIs with O-ring Attachments
Surgical Procedures. After a midcrestal incision, a mu-
coperiosteal flap was raised exposing both labial and
lingual aspects. If bone irregularities were present,
slight vertical ridge reduction was performed to flat-
ten the crestal ridge. The left and right mental foramen
was exposed prior to implant placement to ascertain
its position. The implants were symmetrically posi-
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Zygogiannis et al
Excluded (n = 62)
Group 2
Immediate loading was not possible for
all patients in this group
Group 2A Group 2B
Immediate loading (n = 15) Delayed loading (n = 10)
tioned through the midline at a distance of at least 5
mm apart. The implants were placed according to the
surgical protocol recommended by the manufacturer.
A pilot drill was used to make an initial opening to a
mean depth of one-third to one-half the threaded
length of the implant. Each implant was inserted into
the initial opening by rotating it clockwise while exert-
ing downward pressure (self-tapping insertion tech-
nique). The implant was advanced to its final position
with the torque wrench to a minimum of 35 Ncm to
allow immediate loading.
Each patient received four MDIs (3M ESPE MDI) in
the interforaminal mandibular region. The diameters
of the implants were 1.8, 2.1, or 2.4 mm, and their
length ranged from 10 to 18 mm. The mucoperiosteal
flap was repositioned using interrupted and horizontal
mattress sutures.
Prosthetic Procedures. An indirect restorative pro-
tocol was applied to modify the existing prosthesis to
an implant-retained overdenture. An impression was
made using the closed-tray impression technique. The
existing mandibular dentures were hollowed out and
utilized as an impression tray. A polyether impression
material was used (3M ESPE Impregum) to record each
implant’s position accurately. Standard stone model
fabrication techniques were used to form the models.
The dentures were modified in the laboratory by em-
bedding the metal housings and removable O-ring at-
tachments parallel to each other in the denture base.
They were placed in immediate functional loading the
same day of implant placement.
The International Journal of Oral & Maxillofacial Implants 199
Zygogiannis et al
Group 2: Two Straumann Implants with a
Bar-and-Clip Attachment
Surgical Procedures. The surgical protocol for the
Straumann implants was similar to the one described
in the study by Stoker and Wismeijer.3 The location of
the implants was established at an area correspond-
ing to the contact point between the mandibular
lateral incisor and the canine, at which a perforation
was made starting at the deepest point of the fitting
surface of the denture. A crestal incision was made,
and a mucoperiosteal flap was raised both on the la-
bial and lingual aspects. When indicated, a flattening
of the alveolar crest was performed with a bur. The
implant sites were prepared using consecutive twist
drills (Institut Straumann AG) according to the stan-
dard Straumann protocol. Two endosseous implants
(SLActive Standard or Standard plus, Regular Neck
Straumann, Institut Straumann AG) were inserted and
tightened with a torque of at least 30 Ncm. The di-
ameter of the implants was either 3.3 or 4.1 mm, and
their length was 10 or 12 mm.
Prosthetic Protocol. For the implants that achieved
the desired primary stability, transfer copings were in-
serted, and a pick-up impression was made using the
closed-tray implant impression technique. Each den-
ture was used as an impression tray, and an impres-
sion was made under light occlusal pressure using a
polyether impression material (3M ESPE Impregum).
In the dental laboratory, an egg-shaped Dolder bar
(CMST53012P20, Cendres et Métaux SA) was con-
structed soldering the bar gold copings (048.204,
Straumann AG) with bar segments. A metal clip was in-
corporated in the intaglio surface of each denture as a
retention attachment. The following day, two SynOcta
abutments (048.601, Straumann AG) were connected
to the implants and torqued to 25 Ncm with a stan-
dardized manual torque. The accuracy of the bar fit
was checked intraorally. The bar then was torqued
according to the manufacturer’s instructions, and the
denture was seated on the bar.
For those patients for whom immediate loading
(group 2A) was not possible, a delayed loading proto-
col was followed (group 2B). The same prosthetic pro-
cedure was followed in group 2B, only after 3 months
of healing. The 3- and 12-month follow-up evaluations
were completed for all patients, including the patients
in group 2B. All patients, in both immediate loading
groups, were advised to rinse with chlorhexidine di-
gluconate solution (0.12%) twice a day for a week af-
ter the operation. They were instructed not to remove
their mandibular overdentures for the first 48 hours
to prevent tissue overgrowth. After this initial period,
they were instructed to take the dentures out at night.
All patients were advised to maintain a soft diet with
the implant-retained overdenture for 4 weeks. The
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subjects were instructed in a plaque control protocol
at the time of the surgery, and regular follow-up ap-
pointments were scheduled.
Outcome Measures
Before receiving the assigned treatment, participants
completed a questionnaire prompting information on
sociodemographic data (age, sex, education level, age
of existing dentures, number of years being edentu-
lous). Self-administered questionnaires were given
to the patients before implant placement (baseline,
which was 4 weeks after the fabrication of a new den-
ture, when indicated) and at 3 and 12 months after
delivery of the IODs.
Each subject was asked to rate on 100-mm VAS
their level of general satisfaction, as well as the com-
fort and stability of their overdentures, the ability to
chew, clean, and speak. For this purpose, the VAS ques-
tionnaire proposed by Awad and Feine was used.16
The VAS scales carried the anchor words “not satisfied
at all” (0 mm) to “completely satisfied” (100 mm). The
mean values and SD of patients’ satisfaction in gen-
eral and in specific aspects were calculated. The seven
domains assessed were general satisfaction, ease of
cleaning, ability to speak, comfort, esthetics, retention,
and chewing ability. Patients’ satisfaction level was
also evaluated before implant placement, and 3 and
12 months after the IODs were inserted.
In addition, to measure oral health–related quality
of life (OHRQoL), the Oral Health Impact Profile with
20 items (OHIP-20) was used. The items of this version
were scored on a six-point scale, ranging from 1 (nev-
er) to 6 (all the time), higher scores thus indicating a
lower level of OHRQoL. The scores for the seven do-
mains (functional limitations, physical pain, psycho-
logical discomfort, physical disability, psychological
disability, social disability, and handicap) were com-
puted when a maximum of one item had a missing
value. The missing data points were replaced by the
mean of that patient for each scale. Subscale scores
were created by summing the responses to the re-
spective questions.
Statistical Analysis
Baseline demographics and baseline ratings of the
outcome measures were compared between the three
groups using one-way ANOVA and χ2-tests. A two-
way mixed ANOVA (Group [3 levels] × Time [repeated
measure, 3 levels]) was used to assess a difference in
satisfaction and the OHIP scales between the different
measurement moments. The interaction effect was as-
sessed to indicate whether an existing increase in these
scores was related to treatment group. Statistical anal-
ysis was performed using IBM SPSS Statistics 23 (IBM
Corp, 2015).

Table 1   Sociodemographic Data of the Participants
1 2A
Participants per group 25
Sex
 Male 13
 Female 12
Age (y) 67.0 ± 8.0
Education
 Primary 3 2
 Secondary 19
 University 3 1
Age wearing a complete mandibular denture 47.9 ± 16.6
for the first time (y)
RESULTS
The final sample size consisted of 50 patients, 24
men and 26 women aged between 47 and 83 years.
Twenty-five patients received four MDIs in the ante-
rior mandible that were immediately loaded with an
implant-retained overdenture (group 1), whereas the
other 25 received two Straumann interconnected im-
plants. In the latter group, it was possible to load the
implants immediately in 15 patients (group 2A). For
the remaining patients, a delayed loading protocol
was followed, which involved loading of the implants
3 months after placement (group 2B). The follow-up
protocol for this group was the same as for the other
two groups, and this group was treated as a separate
group in the data analysis. One patient from group 2A
was eliminated because he failed to attend the 3- and
12-month follow-up visits. Apart from this patient, all
remaining patients were available for all scheduled
follow-up visits. The sociodemographic characteristics
of the sample are presented in Table 1. There were no
statistically significant differences between the groups
at baseline regarding these characteristics. The base-
line ratings of the outcome measures are shown in
Tables 2 and 3. None of the visual analog scales and
OHIP-20 domains showed a statistically significant dif-
ference between the groups at baseline (P > .05).
The mean scores and standard deviations (SDs) of
patients’ satisfaction levels at follow-up are shown in Ta-
ble 2, including the results of the two-way mixed ANO-
VA (main effect for time and interaction effect). There
was a difference in general satisfaction (F2,44 = 81.006,
P < .001) between baseline and 3 months and between
baseline and 12 months postoperatively, indicating
an increase in satisfaction. This increase did not dif-
fer between the three treatment groups (F4,90 = 1.838,
P = .128). Similarly, there was a difference in the ability
to speak, in comfort, esthetics, retention, and ability
to eat between baseline and 3 months and between
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Zygogiannis et al
Group
2B Total Test P
15 10 50
6 5 24 χ2 = 0.56 .755
9 5 26
66.7 ± 7.3 71.9 ± 6.8 67.9 ± 7.7 F = 1.75 .185
2 7 χ2 = 1.57 .814
12 6 37
2 6
41.7 ± 18.0 33.1 ± 10.2 43.0 ± 16.7 F = 3.08 .056
baseline and 12 months postoperatively, indicating an
increase in all these subscales. This increase did not dif-
fer between the three treatment groups for all those
subscales. There was no difference between the three
measurement moments in satisfaction with regard to
keeping the prosthesis clean (F2,44 = 2.205, P = .122 for
the main effect; F4,90 = 0.914, P = .459 for the interac-
tion effect).
The OHIP-20 mean scores and SDs at follow-up are
shown in Table 3. The mean overall OHIP and all of its
subscales were statistically significantly different post-
operatively versus baseline. There was a difference in
the mean overall OHIP scores (F2,43 = 46.863, P < .001)
between baseline and 3 months and between baseline
and 12 months postoperatively, indicating an increase
in patients’ quality of life. This increase in OHRQoL
did not differ between the three treatment groups
(F4,88 = 0.608, P = .658). Patients scored lower on the
OHIP than at baseline for all seven domains; there
was a statistically significant difference in all these do-
mains between baseline and 3 months and between
baseline and 12 months postoperatively. There was no
difference in the scores between the three treatment
groups for the seven domains.
DISCUSSION
The findings of the present study illustrated that after
replacement of conventional dentures with IODs, there
was a dramatic improvement in both patients’ satis-
faction level and OHRQoL. This was true for both the
IODs retained by standard-sized implants (regardless
of the time of loading) and the IODs retained by MDIs.
Subjects reported significant improvement in general
satisfaction. The patients also rated most of the other
functional aspects of the prostheses (speech, comfort,
esthetics, ability to chew, retention) significantly higher
when wearing IODs than when they were still wearing
The International Journal of Oral & Maxillofacial Implants 201
Zygogiannis et al

Table 2   VAS Scales of the Seven Domains at Different Time Frames
Interaction
Domain/ Group 1 Group 2A Group 2B Main effect time effect
time Mean ± SD n Mean ± SD n Mean ± SD n F P F P
General satisfaction 24 14 10 81.006 < .001 1.838 .128
 Baseline 31.08 ± 23.79 14.21 ± 23.53 26.80 ± 25.16
  3 mo 83.58 ± 19.49 84.07 ± 21.52 79.20 ± 24.03
  12 mo 82.54 ± 20.26 79.14 ± 25.15 89.60 ± 17.48
Ease of cleaning 24 14 10 2.205 < .001 0.914 .459
 Baseline 72.88 ± 29.61 76.86 ± 31.60 58.20 ± 37.19
  3 mo 80.21 ± 25.02 88.00 ± 8.17 63.20 ± 34.31
  12 mo 82.21 ± 24.38 83.50 ± 17.88 75.80 ± 24.42
Ability to speak 23 14 10 36.667 < .001 0.873 .484
 Baseline 44.91 ± 26.44 31.64 ± 22.58 32.80 ± 25.30
  3 mo 90.87 ± 8.19 83.36 ± 28.71 73.30 ± 29.55
  12 mo 86.30 ± 17.94 86.21 ± 15.24 79.90 ± 30.58
Comfort 23 14 10 73.289 < .001 1.130 .348
 Baseline 34.96 ± 32.31 13.86 ± 14.65 19.40 ± 17.85
  3 mo 82.43 ± 23.57 83.57 ± 19.09 83.30 ± 18.75
  12 mo 82.04 ± 21.85 79.79 ± 22.93 82.10 ± 27.45
Esthetics 24 13 10 41.191 < .001 1.684 .161
 Baseline 60.21 ± 26.56 54.21 ± 25.72 37.20 ± 33.24
  3 mo 85.79 ± 21.66 87.00 ± 17.04 77.80 ± 20.76
  12 mo 88.08 ± 13.55 89.31 ± 11.47 89.60 ± 16.91
Retention 24 14 10 149.547 < .001 2.276 .067
 Baseline 20.21 ± 23.80 7.57 ± 11.37 17.00 ± 14.41
  3 mo 89.46 ± 12.18 88.43 ± 12.23 79.80 ± 24.84
  12 mo 91.71 ± 8.88 75.71 ± 29.74 82.30 ± 20.07
Ability to eat 24 14 10 123.402 < .001 0.491 .743
 Baseline 25.00 ± 23.07 18.50 ± 19.46 22.70 ± 18.14
  3 mo 81.92 ± 21.85 84.00 ± 16.71 87.30 ± 14.06
  12 mo 85.62 ± 15.21 79.14 ± 18.08 89.40 ± 14.15

conventional dentures. Likewise, all participants report-
ed statistically significant enhancement in their OHRQoL
in total, as well as with specific question items. The out-
come furthermore indicated that this enhancement was
independent of whether the patient was treated with
four MDIs with O-ring attachments or two Straumann
conventional implants with a bar attachment mecha-
nism. The observed differences were maintained over
a 1-year period. After the conversion to IODs, however,
there was no improvement in the ability to clean easily
under the prostheses. That was probably because in sev-
eral cases, the IODs had to be relieved after the implant
placement in the anterior region due to a swelling that
was present and the subsequent pain that the patients
experienced during insertion of the dentures. This might
have led to food impaction under the IODs compromis-
ing patients’ ability to maintain good oral hygiene. There
were no aspects in which the denture satisfaction scores
became significantly worse following treatment.
The positive effects were rather expected since it
has been argued that conventional dentures are un-
likely to meet patients’ expectations of satisfaction.17
Moreover, it has been shown that mandibular
two-implant overdentures are a more satisfactory
therapy than conventional dentures for edentulous
patients.18 Thomason et al reported high satisfaction
scores given by the patients 6 months after provi-
sion of implant overdentures in the mandible. In their
study, patients with implant overdentures retained by
standard-sized implants rated their general satisfac-
tion approximately 36% higher than did patients with
conventional dentures.19
All the aforementioned studies referred to a de-
layed loading protocol. In the present study, all pa-
tients who received standard-sized implants to retain
IODs reported a significant improvement of their sat-
isfaction levels, regardless of whether an immediate or
a delayed loading protocol was followed. The number
of studies that have assessed patients’ satisfaction with
IODs using a structured questionnaire when an imme-
diate loading protocol was applied is limited. In one of
them, conversion of a conventional denture to an IOD
had a positive effect on patients’ perception of stability
and retention, measured on a VAS.20

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 Zygogiannis et al

Table 3   OHIP-20 Scales of the Seven Domains at Different Time Frames
Interaction
Group 1 Group 2A Group 2B Main effect time effect
Domain/time Mean ± SD n Mean ± SD n Mean ± SD n F P F P
Functional limitation 23 14 10 37.864 < .001 0.382 .821
 Baseline 12.78 ± 2.97 14.50 ± 2.378 11.90 ± 4.12
  3 mo 7.91 ± 3.56 9.07 ± 3.12 6.80 ± 2.97
  12 mo 7.83 ± 3.60 8.07 ± 3.38 6.70 ± 2.95
Physical pain 23 14 10 55.366 < .001 0.839 .504
 Baseline 14.65 ± 4.30 16.64 ± 4.09 12.80 ± 4.66
  3 mo 7.78 ± 4.20 8.57 ± 4.01 7.10 ± 2.60
  12 mo 7.74 ± 4.10 7.45 ± 3.49 6.50 ± 3.06
Psychologic discomfort 23 14 10 11.404 < .001 0.395 .812
 Baseline 5.17 ± 3.11 4.79 ± 3.12 5.00 ± 3.13
  3 mo 2.70 ± 0.92 2.79 ± 1.42 2.80 ± 1.32
  12 mo 3.09 ± 1.89 2.71 ± 1.20 2.60 ± 0.70
Physical disability 22 14 10 29.903 < .001 0.441 .779
 Baseline 11.29 ± 4.47 12.76 ± 4.27 8.90 ± 4.07
  3 mo 6.32 ± 2.86 6.83 ± 3.58 5.20 ± 3.12
  12 mo 6.41 ± 2.69 7.00 ± 2.54 5.30 ± 1.57
Psychologic disability 23 14 10 27.109 < .001 1.847 .127
 Baseline 4.70 ± 2.44 6.43 ± 3.25 5.40 ± 2.67
  3 mo 2.74 ± 1.05 2.64 ± 1.28 2.50 ± 1.08
  12 mo 3.13 ± 1.89 3.00 ± 1.36 2.10 ± 3.16
Social disability 23 13 10 11.063 < .001 0.596 .666
 Baseline 5.83 ± 3.17 6.08 ± 3.30 4.50 ± 1.51
  3 mo 3.83 ± 2.44 3.85 ± 1.91 3.40 ± 0.70
  12 mo 3.96 ± 2.31 3.69 ± 1.49 3.80 ± 1.75
Handicap 23 14 10 11.432 < .001 0.554 .696
 Baseline 3.74 ± 1.98 4.07 ± 2.53 3.20 ± 1.62
  3 mo 2.13 ± 0.34 2.57 ± 1.50 2.10 ± 0.32
  12 mo 2.74 ± 1.42 2.79 ± 1.42 2.20 ± 0.63

With regard to the patient satisfaction with IODs
retained by four MDIs, the results are in accordance
with those obtained by Elsyad, who evaluated patients’
satisfaction during a 5-year prospective clinical study
with IODs retained by immediately loaded MDIs.14 Sig-
nificant positive differences were detected between
observation times with regard to comfort, eating food,
talking, appearance, stability/retention of the IODs,
and socialization. The main limitation of that study
was the failure to use a comparison group, as well as
baseline ratings of patients’ satisfaction before implant
placement, which made it difficult to attribute the
changes observed to the therapy provided. Another
prospective study showed that IODs retained by MDIs
were rated significantly better than complete conven-
tional dentures. The patients reported the greatest
improvement in stability, comfort, and chewing abil-
ity—especially in the ability to chew hard and sinewy
food particles.21
The present study used the VAS questionnaire pro-
posed by Awad and Feine.16 This is a validated ques-
tionnaire that has been found to be sensitive in the
edentulous population. It includes detailed questions
with regard to specific treatment characteristics that
patients consider important, giving an insight into
which aspects might be improved by dental prosthe-
ses with implant support.
With regard to patients’ perception of the impact
of oral disorders on their psychosocial well-being, the
OHIP, developed by Slade and Spencer in 1994, is the
most comprehensive and widely used measurement
method.22 Although a short version was introduced
for edentulous patients, a modified shortened version
that has measurement properties comparable with
the full version was proposed by Allen and Locker as
more appropriate to use for this group of patients.11
Based on measurement of OHRQoL with the OHIP-20,
the findings from a randomized controlled clinical trial
indicated that edentulous patients who had received
IODs experienced greater improvement than did pa-
tients who had received conventional dentures.23
Heydecke et al used the 20-item version of the OHIP
(OHIP-20) to compare the impact of IODs on OHRQoL
in completely edentulous patients.12 The results

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Zygogiannis et al
indicated that IODs retained by two implants did im-
pact greatly on the OHRQoL parameters. In these stud-
ies, standard-sized implants were used, which were
loaded several months after implant placement. By
contrast, Scepanovic et al used the OHIP-20 to evalu-
ate the OHRQoL for patients wearing IODs retained
by immediately loaded MDIs.21 Similar to the present
study, the patients reported significantly lower values
(improved quality of life) in all domains than the values
obtained with the conventional complete dentures. In
the present study, the positive impact was sustained
at the 1-year follow-up. Alfadda et al showed that the
improvement in OHRQoL following rehabilitation with
IODs retained by immediately loaded implants might
be sustained over a 5-year follow-up period.24
The eventual goal of any health care is to improve
patient-based outcomes, namely, patients’ perspective
in parameters related to function, pain, and discomfort
as well as patients’ perception of emotional and behav-
ioral responses to health interventions. Therefore, pa-
tients’ perceptions of how implant therapy contributes
to their quality of life should always be considered in
clinical trials.25 The OHIP-20 could be used to evaluate
negative impacts specifically related to edentulous
patients and aid in the development of effective inter-
ventions for edentulous patients.26
In all cases, the IODs were opposed by a convention-
al complete denture, eliminating the potential adverse
effect of forces with different magnitudes of stresses as
a confounding factor. The results of the present study
referred to edentulous patients who had sufficient
bone volume for placement of implants with a diam-
eter of 10 mm or longer. Therefore, the results cannot
be extrapolated to patients with extremely resorbed
mandibles. Patients were in general satisfied with their
IODs, regardless of the type of implants used or the
timing of loading. One might argue, however, that this
is related to the fact that all patients included in the
study were dissatisfied with the retention of their con-
ventional denture. A potential bias might have been
the probability that subjects would try to avoid up-
setting the clinician by indicating a greater degree of
satisfaction with implant treatment. In an academic en-
vironment, elderly patients, especially, might develop
a degree of “friendship” toward their dentist. Therefore,
some patients may have been protective of the dentist
when filling out the questionnaires.27 It might be as-
sumed that assessments 3 months after delivery could
affect patients’ ratings in favor of the new treatment
(IODs).28 However, the ratings have remained stable at
the 1-year follow-up period, which might have been
long enough to neutralize this “protectiveness.”
With regard to the satisfaction ratings, the base-
line ratings were comparable among the groups,
since there were no statistically significant differences
204 Volume 33, Number 1, 2018
© 2018 BY QUINTESSENCE PUBLISHING CO, INC. PRINTING OF THIS DOCUMENT IS RESTRICTED TO PERSONAL USE ONLY.
NO PART MAY BE REPRODUCED OR TRANSMITTED IN ANY FORM WITHOUT WRITTEN PERMISSION FROM THE PUBLISHER.
between the three groups for all domains. However,
a limitation of this study might be that, for patients
who received new dentures, the baseline question-
naires were completed 4 weeks after delivery of the
new prostheses. It has been reported that fabrica-
tion of new dentures might lead to an improvement
of patients’ satisfaction in terms of comfort and ability
to eat and speak.29 This period of 4 weeks might not
have been long enough to demonstrate a potential
improvement.
The highest ratings reported at baseline for all the
satisfaction subscales were considered low enough
to conclude that patients were not satisfied with their
conventional dentures (for example, 35 mm on the
100-mm VAS for the domain comfort) and in accor-
dance with the baseline values reported in other stud-
ies.18 Even though the differences between groups
with regard to the baseline ratings might become sta-
tistically significant if the sample size is increased, they
are not considered to be clinically important. Further-
more, the patients’ posttreatment satisfaction ratings
were much higher than the baseline ratings (in the re-
gion of 80 mm on the 100-mm VAS), regardless of the
group they were allocated to. Thus, this increase in sat-
isfaction is considered significant in terms of its clinical
relevance. Although the sample size calculation was
not based on the patient-based outcomes, the power
of this study was considered high enough to detect
statistically significant differences of a clinically mean-
ingful magnitude in time and between the groups.
CONCLUSIONS
The findings of this clinical trial revealed a significant
improvement in the satisfaction as well as in the quality
of life after denture stabilization with implants, regard-
less of the type of implants used and the time of load-
ing. Rehabilitation of the edentulous mandible with
IODs retained either by four immediately loaded MDIs
or two standard-sized implants and a bar-and-clip at-
tachment system (immediately or delayed loaded) re-
sulted in equally significantly better ratings of patients’
general satisfaction as well as ability to speak, com-
fort, esthetics, retention, and ability to chew 3 and 12
months after treatment. Furthermore, these patients
had significantly fewer oral health–related quality of
life problems following implant rehabilitation. The
positive effect was evident 3 months postdelivery and
remained stable over a period of 1 year. In terms of pa-
tients’ satisfaction levels and quality of life, mandibular
overdentures retained by immediately loaded MDIs
can offer an improvement of equal magnitude with
the improvement achieved by overdentures retained
by standard-sized implants.

ACKNOWLEDGMENTS
This study was supported by 3M ESPE Deutschland GmbH, Ger-
many. The company did not participate in the study design, data
collection and analysis, decision to publish, or in manuscript
preparation. All the investigators involved in the study were staff
members of a university clinic and had no affiliation with the
company. The authors did not have any financial interests, ei-
ther directly or indirectly, in the products listed in the study.
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