Systematic Review Comp Inlays Final

COMPOSITE INLAYS: A SYSTEMATIC REVIEW
A dissertation submitted to the University of Manchester for the degree of

Master of Science in Dental specialties (Fixed and Removable
Prosthodontics) in the Faculty of Medical and Human Sciences
2012
EFSEVIOS GRIVAS
SCHOOL OF DENTISTRY
List of contents
Section Pg
List of Tables 4
List of Figures 4
List of Appendices 5
List of Abbreviations 6
Abstract 7
Declaration 8
Copyright statement 9
Acknowledgements 10
1. Introduction and background 11

1.1 Tooth restorations 12
1.2 Materials 12
1.2.1 Gold 13
1.2.2 Porcelain 13
1.2.3 Composite 14
1.3 Comparison of inlays 16
1.4 Clinical procedures 18
1.4.1 Preparations 18
1.4.2 Colour choice 19
1.4.3 Impressions 19
1.4.4 Construction 19
1.4.5 Provisionalization 20
1.4.6 Placement procedure 20
1.5 Indications and contraindications of inlays and onlays 23
1.6 Available studies 24
1.7 Why this review is important? 25
2. Aims and objectives 26

3. Methods 28
3.1 Inclusion-exclusion criteria 29
3.2 Search strategy 30
4. Results 31
4.1 Description of studies 32
2
4.2 Quality assessment 33
4.3 Characteristics of the included studies-Data extraction 36
4.4 Effects of interventions 54
4.4.1 Composite inlays vs ceramic and gold 54
4.4.2 Composite inlays versus direct composite fillings 56
4.4.3 Clinical performance of composite inlays on premolars versus molars 58
4.4.4 Clinical performance of composite inlays on small cavities versus large 59
5. Discussion 60
5.1 Summary of evidence 61
5.1.1 Composite inlays versus ceramic and gold 61
5.1.2 Composite inlays versus direct composite fillings 62
5.1.3 Composite inlays on premolars versus molars 62
5.1.4 Composite inlays on small cavities versus large 63
5.2 Limitations 63
5.3 Quality of the evidence 64
5.4 Biases of the review process 65
5.5 Implications for research 65
5.6 Implications for practice 66
6. Conclusion 67
7. Appendices 69
8. References 77
Word count: 16332
3
List of tables
Table 1 Study's quality assessment form-Questions to be answered 33
Table 2 Study's quality assessment form-Answers to the questions I 34
Table 3 Study's quality assessment form-Answers to the questions II 35
Table 4 Huth 2011 37
Table 5 Fasbinder 2005 38
Table 6 Wassell 2000 39
Table 7 Thordrup 2006 40
Table 8 Spreafico 2005 41
Table 9 Pallessen 2003 42
Table 10 Alhadainy 1998 43
Table 11 Gladys 1995 44
Table 12 Manhart 2001 45
Table 13 Van Dijken 2000 46
Table 14 Donly 1999 47
Table 15 Manhart 2000 48
Table 16 Kukrer 2004 49
Table 17 Mendonca 2010 50
Table 18 Cetin 2009 51
Table 19 Dukic 2010 52
Table 20 Kaytan 2005 53
Table 22 Studies comparing composite vs ceramic and gold 54
Table 23 Composite inlays vs direct composite fillings 56
Table 24 Premolars vs molars 58
Table 25 Small cavities vs large 59
List of figures
Figure 1 Flow diagram of study identification 32
4
List of appendices
Appendix 1 Clinical procedures 70

Appendix 2 Search strategy 73
Appendix 3 Characteristics of excluded studies 74
Appendix 4 List of the resin composites tested in the included studies 75
5
List of abbreviations
WHO World Health Organization

CAD-CAM Computer Aided Design-Computer Aided
Manufacturing
Bis-GMA Bisphenol-A Glycol dimethacrylate
Bis-EMA Ethoxylated bisphenol A glycol dimethacrylate
UDMA Ethoxylated urethane dimethacrylate
UEDMA Urethane dimethacrylate
TEGDMA Triethylene glycol dimethacrylate
TCD Tricyclodecane urethane
MOD Mesial-Distal-Occlusal
RCT Randomised Clinical Trial
CCT Controlled clinical Trial
CS Case Series
USPHS United States Public Health Service
CDA Californian Dental Association
ADA American Dental Association
DIMA Dimer acid-based dimethacrylates
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Abstract
Objectives: The purpose of this study is to review the available literature related to
composite inlays and onlays, to extract and analyze the included information and to
determine the clinical effectiveness of them compared to ceramic and gold as well as
compared to direct composite fillings. Furthermore to assess whether any difference exists
when using composite inlays for restorations regarding the tooth type (premolars against
molars) and cavity size (1-2 surface against multisurface).
Data sources: All the literature published up to July 2012 was assessed by electronic search
and hand searching. A quality checklist of 24 items that has been introduced in ceramic
inlays reviews has been used to evaluate the scientific quality of the identified trials.
Subsequently data were extracted from the selected studies to answer the hypotheses.
Results: Following the assessment of twenty-three studies which met the inclusion criteria
there was insufficient data to answer the hypothesis of no difference between composite
and other types of materials for the construction of inlays regarding the longevity and
aesthetic quality while insignificant difference was found for the postoperative sensitivity.
For the same clinical criteria composite inlays seem to have no significant differences with
composite fillings. Clinical performance of composite inlays on premolars was superior to
that on molars while there was not enough evidence to answer the hypothesis of
insignificant difference between small and large composite inlays.
Conclusion: Despite the heterogeneity of the available clinical trials composite inlays seem
to be an effective method for the restoration of posterior teeth.
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Declaration
No portion of the work referred to in this dissertation has been submitted in support of an
application for another degree or qualification, of this or any other university or other
institute of learning.
8
Intellectual property statement
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9
Acknowledgements
The author would like to thank Mr.Reza Vahid Roudsari for his priceless help
and guidance in writing this dissertation. I would also like to thank my wife
Zoe and my daughter Maria-Eleni for their patience and understanding.
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1. Introduction and background
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1.1 Tooth restorations
Tooth caries is a worldwide epidemic disease which affects almost 100% of the adult
population in the majority of the countries according to the WHO (WHO, 2010). Its result
can be extremely catastrophic for the dentition. For many decades clinicians could only use
gold and amalgam as the only available materials for the restoration of decayed teeth but
the demand for more aesthetic options led to the use of porcelain and composite in
dentistry. Nowadays the restoration of severely damaged teeth can be a real challenge for a
dentist who wants to follow the rules of the contemporary conservative dentistry and
respects both tissue and structure of tooth. The construction of inlays and onlays are a
unique ally at this effort. According to the Glossary of prosthodontics terms an inlay is :
“A fixed intracoronal restoration, a dental restoration made outside of a tooth to correspond
to the form of prepared cavity, which is then luted into the tooth” while onlay is: ”A
restoration that restores one or more cusps and adjoining occlusal surfaces and is retained
by mechanical or adhesive means” (2005). The clinician must be familiar with the special
procedures required for the effective preparation of an onlay which is occasionally
demanding and differs depending on the material.
1.2 Materials
The ideal material for the construction of a restoration and consequently inlays and onlays
should have specific properties such as:
 Biocompatibility, which means to be compatible with the mouth tissues and
especially avoid any irritation to the vital pulp (postoperative sensitivity).
 Longevity, which has to be better than the direct materials used.
 Seal of the restoration, to avoid microleakage and decay.
 Restore mechanically and mimic aesthetically the tooth morphology (Dietchi and
Spreafico, 1999).
 Respect the tooth tissue which means conservative preparation to the underlying
tooth and minimal wear to the antagonist.
 Easy to handle, easy maintenance and satisfactory cost – effectiveness.
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1.2.1 Gold
Gold was the first material to be used for several decades for the construction of inlays and
still is the “gold” standard regarding the fixed restorations (Studer et al., 2000). High noble
alloys, gold-platinum or gold –palladium which have an Au concentration of 40% or more
are appropriate for inlays (Craig and Powers 2000). The perfect fit, the low wear to the
antagonist, the ideal longevity, the corrosion resistance and the high strength are amongst
the advantages while high cost, demanding preparation and poor aesthetics are the
disadvantages (Brown, 2005).
1.2.2 Porcelain
The growing demand for higher level of aesthetics led to the use of porcelain in dentistry
which was then the next material to be used. The first porcelain inlay was created in 1889
by Land as stated by Marra (Marra, 1970). The use of porcelain was then abandoned
because of the fragility, difficulty of bonding and unacceptable fitting (Banks, 1990).
Nowadays dental ceramics can be divided in three major categories according to the core
material (Conrad et al., 2007)
 Glass ceramics: Three subdivisions which can be used for inlays
a) Feldspathic
b) Leucite: Two versions IPS Empress (heat –pressed) and IPS ProCAD (milled) of
low strength ceramics.
c) Lithium –disilicate: IPS Empress 2 was the first of the category to get introduced
and is constructed through lost wax and heat-pressed technique. Its flexural strength
is three times of IPS Empress (Qualtrough and Piddock, 2002). IPS emax Press
(introduced in 2005) is an improved porcelain with improved properties and
translucency because of further improvement in firing techniques which is probably
the most updated aesthetic ceramic material thus ideal for inlays (Stappert et al.,
2006).
 Aluminium-oxide based or glass infiltrated ceramics.
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They are structured of an alumina skeleton infiltrated with glass. Their flexural strength
and fracture toughness is inferior to Zirconia and superior to glass ceramics. Rarely
used for inlays construction.
 Oxide ceramics or high performance
Their major and most used member is yttrium tetragonal zirconia polycrystalls. Yttrium
has been used to stabilize zirconia at its desirable tetragonal phase. Oxide ceramics are
not being used for inlays construction because of their reduced translucency.
Ceramic inlays have the following advantages:

 Perfect aesthetics compared to gold and amalgam
 Biocompatibility and less plaque accumulation
 Wear resistance
On the other hand their disadvantages are:
 Brittleness
 Wear of opposing teeth and restoration
 Low maintenance potential
 Difficult intraoral polishing
 Cost
1.2.3 Composite
The third material to be used for inlays construction is composite. The definition according
to the Glossary of Prosthodontics terms is:” A highly cross-linked polymeric material
reinforced by a dispersion of amorphous silica ,glass, crystalline or organic resin filler
particles and/or short fibers bonded to the matrix by a coupling agent” (2005). The
continuing evolution of resin composites since 1963 when Bowen firstly described Bis-
GMA resin composites (Bowen, 1963) led to high strength, aesthetic well fitted
restorations that can be used for the construction of posterior restorations.
They are consisted of the:
a) The organic resin matrix which is composed of the monomer, commonomers,
inhibitors, initiator, UV stabilizers and pigments. Since the fabrication of the Bis-GMA
which was the first monomer many others have been invented by manufacturers like
UDMA (Urethane Dimethacrylate), UEDMA (Aliphatic urethane dimethacrylates), and
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TEGDMA (Triethyleneglycol dimethacrylate). The letters have been used as diluents to
decrease the high viscosity of the former and modify composite’s clinical performance
(Asmussen and Peutzfeldt, 1998), although this has been shown to increase the
polymerization shrinkage (Antonucci and Bowen, 1976). More recently introduced are the
siloranes which tried to decrease the polymerization shrinkage and keep the desired
mechanical properties at the same time (Weinmann et al., 2005). Other monomers that
have been used are the low viscosity TCD (Tricyclodecane urethane ), dimer acid-based
dimethacrylates (Trujillo-Lemon et al., 2006) and Ormocers (Herbert Wolter, 1994),all
aiming to decrease in various ways the polymerization shrinkage.
b) The inorganic mineral reinforcing fillers. Inorganic fillers that can be used are
quartz, glass and silica whereas glass is the most frequently used (O'Brien, 2002).
c) The coupling agents which bind the organic and inorganic part together
They can be classified in several ways but the most appropriate is according to their
fillers size which is of major importance and is gradually decreasing through the last
decades aiming in improved mechanical properties.
 Macrofilled (1-10 μm): Poor aesthetics and ability to be polished. Have been
improved through the decades.
 Microfilled (40 -50 nm): More aesthetic, but not as strong as the earlier. Not
acceptable properties comparing to following categories especially for use in highly
stressed restorations. Filler loading is inferior to Nanofilled. Excellent polishability
characteristics. Mechanical characteristics are inferior to higher filled materials
(Braem et al., 1994).
 Hybrid (10-50 μm+40nm): Tries to combine advantages of the previous. The
rationale for their construction was to combine strengthens of each of them. Can be
further divided to microhybrid and nanohybrid. High mechanical properties
appropriate for highly-stressed restorations. Most of the composites today are
hybrids.
 Nanofilled (5-100 nm): They are the more recently introduced having increased
translucency and polishability similar to microfills while their physical features are
close to those of hybrid composites (Mitra et al., 2003).
Size of the particles directly affects the characteristics of the composites by decreasing
polymerization shrinkage and increasing others like hardness, flexural strength (Ikejima et
al., 2003), polishability and wear resistance (Mitra et al., 2003). In other words,
nanocomposites which are composed of the smaller available fillers can be used either for
posterior stress-bearing restorations and anterior aesthetic demanding restorations (Beun et
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al., 2007). In a very recent in vitro study Ilie and co-workers concluded that mechanical
characteristics of the available composites differ even in the same category. Furthermore,
although few differences were identified between microhybrid and nanohybrid in general,
some of the nanohybrid performed better than microhybrid (Ilie et al., 2012). Apart from
the size of the fillers the shape of them has been proved in recent studies to affect the
material’s properties where spherical fillers exhibit lower shrinkage than irregular fillers
(Satterthwaite et al., 2012). Ceromer which stands for Ceramic Optimized Polymer is a
unique material which can be handled as a composite but keeps the ceramic’s aesthetic at
the same time (Duke, 1999). Ceramic particles are used as fillers and can been used for the
construction of lab made inlays as well as metal free bridges (Iglesia-Puig and Arellano-
Cabornero, 2003, Gemalmaz and Kukrer, 2006).
Laboratory composite resins are composites with composition similar to the conventional
composites which builded extraorally and usually need additional curing by heat, pressure
or light. The simultaneous gradual improvement of composite composition and mechanical
properties marked the pass from the first to the second generation of the lab composites
during the ‘90s. To put it differently, whereas the first generation’s weight percentages for
organic and inorganic particles were 66% and 33% respectively, in the second generation
these are opposite. Smaller and different filler particles (silica barium glass and ceramics),
different shapes, improved monomers and curing methods boosted their mechanical
properties (Touati and Aidan, 1997)
1.3 Comparison of inlays
Composite inlays versus ceramic and gold

Advantages:
 Aesthetic appearance especially if this is combined with various shades and
multiple translucencies (Layering technique) can be equal or superior to porcelain.
 Repairable, easy to maintain and refurbish (Can be modified by adding new
material to old).
 Low cost compared to porcelain and gold alloys.
 Bonding to dental tissue compared to gold.
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 Minimal wear to occluding enamel compared to porcelain.
 Can be constructed either in the lab or chairside (indirect, semi-direct technique or
even direct and recurred extraorally).
 Easily polishable outside or inside mouth.
 Similar mechanical properties to dentine compared to ceramic (Dukic et al., 2010).
 Ability to absorb forces make them an ideal restoration for cracked teeth (Signore
et al., 2007).
Disadvantages:
 Inferior longevity compared to ceramics and amalgams.
 Lower strength especially when used in limited space restorations compared to
gold.
 Colour is changing during time.
 Possible release of toxic substances (Van Landuyt et al., 2011).
 Microleakage
 Secondary caries
Composite inlays versus direct composite restorations

Advantages:
 Lower polymerization shrinkage due to more in-depth curing.
 Superior wear resistance and strength due to additional heat or light curing.
 Potential for better surface characteristics, details, polishability and subsequently
better aesthetics.
 Better occlusal anatomy can be achieved.
 Improved proximal contacts
Disadvantages
 More time and skill demanding.
 More destructive to tooth tissue as a preparation prior to impression needed.
 Lab or extra instruments in practice needed.
 Temporary restoration needed.
 Extra cost
 Extra appointments and more clinical steps.
 More technique-sensitive due to sensitive luting procedure.
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1.4 Clinical procedures
There are some similarities and differences between the designed preparations according to
the material we use for the construction of onlays and inlays. Guidelines for these
preparations have changed from the ones that G.V.Black stated for amalgam preparations.
1.4.1 Preparations
Preparations for ceramic and composite inlays are not so demanding as gold although the
basic principles are the same. After removing any caries and old restorative materials, then
the occlusal part of the cavity is prepared while following the special anatomic features of
each tooth. The outline of the cavity must be simple and smooth without many or steep
curves. Minimum thickness of remaining wall must exhibit 2.0 mm to avoid a cusp fracture
while a convergence of without any beveling of the outer margins has been proved to
be needed to ensure an easy and effective placement and cementing (Wassell et al., 1992) .
An isthmus thickness more than 2.0 mm in width and depth is needed for materials
strength. Proximal overhang of the restoration not only has to create an interproximal
contact but it’s width must not exhibit 2.0mm in order to avoid an unwanted fracture
(Dietchi and Spreafico, 1999). Pulpal and proximal box floor must be flat or concave and
vertical to tooth’s axis while the axial wall of the proximal box must be flat and not
following the convexity of the tooth. In MOD inlays, axial walls must also be converging
to allow the proper seating of it and all the angles must be rounded. In deep cavities
protection of the pulp is needed with Glass ionomer or even calcium hydroxide where
dentine thickness is less than 0.5 mm. Cervical margin of the proximal box must ideally
based on sound enamel unless caries or a previous restoration makes that unrealistic.
Residual enamel and margin design can be an important factor for the restoration (Dietschi
et al., 1995). Cervical margin should be chamfer or rounded shoulder and must follow the
cusp morphology (buccal-lingually) for better aesthetic results because then restoration
margins are blended harmonically with tooth’s grooves and fissures. Undercuts must be
covered prior to impression usually with Glass Ionomer. Avoidance of coincidence of
occlusal contacts with margins is of primary importance. When preparing for composite
onlays an occlusal clearance of 1.5 mm is prerequisite. (See appendix 1, picture 1)
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1.4.2 Colour choice
It is of great importance to choose the appropriate colour because the restoration must have
a continuous appearance with the tooth. Shade selection can be made traditionally or with a
dental spectrophotometer which measures accurately tooth’s shade (Chu et al., 2010).
1.4.3 Impressions
Final impressions should be accurate so Addition silicone or Polyether is indicated. If the

cervical margin is at gingival level or subgingival then retraction cord is necessary (double
and soaked in aluminium chloride is better).
1.4.4 Construction
An effective way of classifying the composite inlays has been proposed by Dietschi in his
book (Dietchi and Spreafico, 1999). The way of the construction determines the
classification of the inlays into: Direct when intraorally builded, semi-direct when
fabricated with intra and extra oral steps and indirect when in the lab constructed. In the
direct technique, after the preparation has been finished a water soluble lubricant is applied
on the cavity and the inlay is incrementally builded and cured inside the mouth. Then is
removed and finished extraorally by extra curing and additional polish. A basic
disadvantage of that technique is the potential lock of the restoration inside the cavity when
an undercut has not fully cleared. For the semidirect technique two different ways are
available. First is the classic way of making an impression which is poured chairside with a
fast-setting hard silicone material (bite silicone) and making this way, quickly, a working
model. Inlay is then builded and even a layering technique can be used. The second way is
the constantly improved CAD-CAM technology with Cerec been the most well-known
(Mormann and Krejci, 1992). The rationale of the system is a camera which scans the
prepared tooth and makes a digital impression of it. The prepared cavity usually has to be
covered with titanium –powder prior scanning. The scanned object is then refined by the
operator and the digital model is sent to the milling machine which produces the
restoration by cutting blocks of the material. Nowadays ceramic, titanium, composite,
zirconium and even wax blocks can be used. Diamond-coated cutting rotary disks and burs
19
are milling the blocks in the designed shape. Final polish is performed inside the mouth.
Nowadays polychromatic composite blocks are available but an additional staining is still
needed for better appearance. The third generation of the Cerec machine, Cerec III, has
only recently introduced to the market. Finally the indirect composite inlays and onlays are
lab constructed by experienced technician using various layers and strictly following
manufacturer’s instructions .The working model is poured in hard stone. The finished
restoration is post-cured in light-oven for at least ten minutes to achieve a full in-depth
polymerization (See appendix 1, picture 2).
1.4.5 Provisionalization
A temporary restoration is necessary to protect the prepared cavity from thermal, chemical
and mechanical irritation while isolating the sensitive pulp from bacterial infection and
allowing an acceptable occlusion, function and appearance at the same time. Conventional
temporary cavity filling material can be used for this purpose although alternative materials
are more appropriate such as self-curing or soft light-curing composites.
For extensive period of time, cold-cure acrylic or resin-based temporary inlays can be
constructed using vacuum-form or silicone-putty matrix. It is of primary importance to
avoid using any Eugenol-based material either cements or temporary filling (DeWald et al.,
1988) which can afterwards obstruct the polymerization of the resin cements although
elsewhere this has been judged (Peutzfeldt and Asmussen, 1999).
1.4.6 Placement procedure
Although gold inlays can be bonded normally using glass-ionomer or zinc-phosphate,

ceramic and composite cannot. The cornerstone on the development of inlays was the
introduction of acid etching technique by Buonocore in 1965 which resulted to the modern
adhesive techniques (Buonocore, 1955) and allowed both ceramics and composites to be
used for inlays construction. Acid-etching removes debris from enamel, increases surface
energy and subsequently allows the formation of the resin tags where adhesive bonds to
enamel. Consequently resin cement can bond to enamel. Bonding to dentine is more
complicated. Phosphoric acid removes smear layer and provides dissolution of
hydroxyapatite resulting in collagen collapsing. Priming rehydrates the collapsed collagen
while monomers penetrate the tubules and form the Hybrid layer which micro-
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mechanically bonds bonding agent to dentine (Nakabayashi et al., 1982). Available
bonding agents can be classified into four categories:
a) Three step etch-primer-bond
b) Two step etch and rinse
c) Two step Self –etch primer
d) One step Self-Etch adhesive
Although many clinicians prefer the classic multi-stage approach, a recent systematic
review could not answer the hypothesis of no difference between the available systems.
However, three and two steps agents showed excellent results (Chee et al., 2012).
Apart from the tooth etching an additional etching of the restoration’s fitting surface with
hydrofluoric acid is needed. Application of a silane coupling agent has been firstly
described for the luting of porcelain veneers to tooth (Horn, 1983). Silane coupling agent
provides the bond between the fitting surface of the adhesive restoration and the resin
cement. Its participation is essential when luting ceramic restorations but not always for
composite restorations; however is an area where further investigation is needed (Lung and
Matinlinna, 2012).
Resin cements are the only appropriate for the cementation of the composite inlays. Their
composition is similar to the composite where the organic matrix is filled with fillers. They
are classified according to the way of polymerization to:
a) Chemically polymerized
b) Light-polymerized and
c) Dual cure cements
For the cementation of composite inlays dual-cured cements are more indicated because
light curing can be obtained under a certain thickness of a material (Blackman et al., 1990)
which also depends on several factors like translucency and shade and is limited to less
than 3.0 mm. However an additional light activation is necessary for confirmation of the
complete polymerization of the resin cement (Hofmann et al., 2001). Nowadays the
variation of the available resin cements has grown with self-etch adhesives while resin
cements come in different shades (Rickman and Satterthwaite, 2010). An RCT by Sjogren
and co-workers has shown superior durability for chemically cured resins compared with
dual cure (Sjogren et al., 2004) while the recently introduced self adhesive resin composite
cements are quite promising although longer studies are required (Peumans et al., 2010).
The provisional inlays are removed and the definitive ones are tried-in. Special coloured
glycerine gels can be used that simulate the colour of the resins cement while every aspect
is checked like proximal contacts, occlusal contacts and margins. Transfer of the inlay
inside the mouth is difficult because of its size. Air abrasion pumice can be used for the
21
thorough cleaning of the tooth surface after the necessary isolation by rubber dam
(Rickman and Satterthwaite, 2010). The fitting surface of the inlay on the other hand is
cleaned by sandblasting and ethanol. Silane is then applied on the fitting surface of the
inlay. Simultaneously enamel is acid etched for 30 sec and dentine for 15 sec with 37%
phosphoric acid. Bonding agent is then applied and dried on the tooth without being cured.
Composite inlay is then inserted using dual-curing resin cement. Proper seating is
confirmed before any light curing and can be improved by using Ultrasonic tips. Equally
important is to place separating strips and wedges interproximally prior to cementation
which can prevent the penetration of the cement in any unwanted areas and isolate cavity
from adjacent teeth. Excess cement is thoroughly removed and glycerine gel is applied on
the margins to obstruct oxygen-inhibition of the luting resin surface. Each surface is light
cured for 40 sec and at last occlusion and polish are checked (See appendix1, picture3).
A slightly different approach has been proposed by Magne regarding the application of
bonding agent on dentine prior to impression for adhesive restorations both ceramic and
composite which can be used for dentine bonded crowns, veneers, inlays and onlays called
Immediate Dentine Sealing (Magne, 2005). The bonding agent is applied, dried and light-
cured on dentine immediately after the preparation and certainly before any impression.
The advantages of this technique are:
a) Freshly cut dentine is the ideal base for the agent.
b) The separate curing of the agent compared to the total curing in the original method
of cementation has been proved to result in improved bond free of stress (Magne et
al., 2005)
c) Tooth is isolated from bacterial leakage and other stimuli like thermal or chemical
(Cagidiaco et al., 1996)
d) There is usually no need for anaesthesia at the cementation appointment
e) Composite can be used instead of Glass Ionomer for the blocking of undercuts
f) Light-activated resin cement can be used instead of dual-cure resin cement with
more confidence.
g) Enamel can be etched separately on the next appointment
While the limitations are:
a) Care must be taken when placing a resin temporary restoration because the removal
of it can be very difficult.
b) Glycerine gel must be used to allow the isolation of the outer layer from oxygen.
c) Air –thinning of the agent can cover the margins of the onlay preparations thus a
re-preparation might be indicated.
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d) Cleaning of the agent before cementation can be made by either polishing brushes
or air-abrasion whereas the latter has been proved to be less abrasive (Stavridakis et
al., 2005)
e) Polyether must be avoided for the impression because Immediate Dentine Sealing
has been evidenced to affect negatively impression’s surface (Magne and Nielsen,
2009)
1.5 Indications and contraindications of inlays and onlays
Although a variety of factors can affect dentist’s choice for the choice of the ideal
restoration for every patient the following indications can be proposed:
a) Severely or even moderately damaged teeth which cannot be restored directly by
either composite or amalgam due to the extensive size of the cavity. Large
composite fillings can result in polymerization stresses.
b) Endodontically treated teeth which have been weakened because of the effort to
access the pulp chamber
c) When the depth of the cavity is less than 2.0 mm which is not enough for an
adequate thickness of a ceramic inlay.
d) When we want to achieve an accurate and detailed tooth morphology
e) Whenever it is difficult to restore directly e.g. posterior teeth or patient can not
open properly his mouth.
f) When an increase at the Occlusal Vertical Dimension has been planned or quadrant
restorations or full-mouth rehabilitation is needed because better designed and
predictable restorations can fabricated indirectly (Hemmings et al., 2000).
g) Tooth Surface Loss cases where posterior teeth are affected
h) When the patient is allergic to metal restorations
i) Restoration and reinforcement of partially fractured, cracked teeth. It has been
proven to be efficient even in sensitive teeth (Signore et al., 2007).
While in the following situations an alternative restoration is regarded as a better option.

a) Minor cavities
b) If lab cost must be avoided and necessary equipment for their fabrication is not
available in the practice
c) Dentist does not have the knowledge and the skills
d) Minor residual dental tissue
23
e) If tooth has to serve as an abutment
f) Lack of enamel circumferentially (if resin cements will be used), although modern
resin cements can partially overcome this problem.
g) Bruxists or other parafunctional patients. However, clinical studies on recently
introduced composite materials (Ceromers) have been shown great results when
used in bruxists (Kukrer et al., 2004).
1.6 Available studies
Even though in-vitro studies can give evidence for the effectiveness of an appliance in
medicine or dentistry, clinical trials are necessary to prove the clinical effectiveness in real
life. Furthermore the oral environment cannot be simulated in the lab conditions despite a
great effort has been made to produce machines that can equal that. Controlled clinical
trials and especially randomized clinical trials are the most ideal studies when a restoration
is tested. Several outcomes have been used to check the clinical effectiveness of composite
inlays. The basic problem is that most of them are subjective. Calibration of the examiners
is one measure that can be used to reduce the potential bias. Examiners must be trained and
reach a consensus prior to any decision. Literature is missing universally accepted criteria
for this assessment but the most frequently used ones are the USPHS criteria and their
modifications (Cvar and Ryge, 1971, Bayne and Schmalz, 2005) while less frequently the
CDA criteria are used. The most evaluated outcomes are:
a) Surface texture
b) Colour match
c) Marginal discolouration
d) Marginal integrity
e) Integrity of the tooth and restoration
f) Occlusion
g) Postoperative sensitivity
Special probes and visual inspection are used for the grading of the restorations in a three
or four grades scale (Alpha, Bravo, Charlie and Delta).
24
1.7 Why this review is important?
A systematic review collects the important information from clinical trials preferably
randomised while concludes and appraises all that information and finally gives to the
clinician –reader details that can be used in practice. Even though three systematic reviews
(Pol and Kalk, 2011, Hayashi et al., 2003, Banks, 1990) have been found on ceramic inlays
none has been identified considering composite inlays and this is the most important
reason this systematic review is essential for developing the scientific knowledge on the
use of composite for the construction of inlays.
25
2. Aims and objectives
26
The aim of this study is to evaluate the clinical effectiveness of indirect composite inlays
using a systematic review of the available literature.
The objectives of the study are to compare the indirect composite inlays to direct
composite restorations as well as to ceramic and gold inlays. Furthermore a comparison of
their clinical effectiveness regarding tooth type and cavity size is planned.
The Null Hypotheses are:
1. There is no difference in longevity, postoperative sensitivity and aesthetic quality in

composite inlays compared to ceramic and gold inlays.
2. There is no difference in longevity, postoperative sensitivity and aesthetic quality in
composite inlays compared to direct composite restorations.
3. The clinical performance of composite inlays in premolars does not differ from that
on molars.
4. The clinical performance of composite inlays in 1 - or 2- surface preparations does
not have significant difference compared to multi surface preparation.
27
3. Methods
28
3.1 Inclusion-exclusion criteria
Criteria for including studies for this review
 Types of studies
Randomised Control Trials (RCT), Controlled Clinical Trials (CCT) and Case
Series (CS) that evaluate composite resin inlays and onlays for the restoration of
posterior teeth. Split-mouth design and parallel design studies have been used.
 Types of participants
Adult males and females with permanent vital healthy teeth that have been treated
in universities, dental hospitals or private practices have been included
 Types of interventions
Composite inlays and onlays that have been used in conjunction with ceramic and
gold inlays as well as with direct composite restorations. No restriction was made
for the way of construction. In other words chairside inlays like those fabricated by
CAD-CAM technology and lab made were included.
 Types of outcome measures
Longevity, colour match, postoperative sensitivity.
Criteria for excluding studies for this review were:
 Non –adults studies

 Non- English
 In-vitro
 Case reports
 If they did not have a separate part devoted to composite inlays or if they were
speaking only for ceramic or gold inlays without any comparison to composite
inlays.
 Directly made inlays without any part of the procedure occurred extraorally.
 Inlays being used as retainers for bridges or removable dentures.
 Assessing a different aspect of inlays procedure like cementing or polishing
 A follow up period of less than 12 months
 Restorations like veneers or crowns, or any other type of restoration on anterior
teeth.
29
3.2 Search strategy
Electronic search has been designed for the identification of articles through the OVID
search machine by including the following databases:
-Ovid Medline 1946 to 2012
-Cochrane Central Register of Controlled trials
-Embase 1980 to 2012
Reference lists of the identified articles and available similar systematic reviews were
also screened to find relevant articles. Important prosthodontic journals were hand-
searched focusing on the last 6 months to ensure that no related article has been published
and not included yet in the databases:
-International Journal of Prosthodontics
-Operative dentistry
-Prosthetic dentistry
-Quintessence international
-Journal of adhesive dentistry
Search strategy was applied on the three databases through the OVID search machine. It
was decided to identify articles for the whole of inlays and onlays including ceramics and
gold in order to avoid missing important literature. See appendix 4 for Search strategy.
30
4. Results
31
4.1 Description of studies
The initial search of the databases revealed 299 articles while 11 more were identified
when the reference list of the previous articles was hand-searched. Out of the 310 articles
of the initial sample the following flow diagram which has been designed according to the
PRISMA group is illustrating the flow of the exclusion procedure. The screened articles
have been excluded because they were reviews, non adult or in vitro studies. Subsequently
74 articles were excluded because 67 of them were referred only to ceramics, 4 only to
gold, 1 was discussing titanium inlays and 2 were excluded because the full text was non-
English. After the thorough assessment of the 36 articles 13 more were excluded. See
appendix 5 for the characteristics of the excluded articles.
Figure 1 Flow diagram of study identification

PRISMA group preference of reporting items (Moher et al., 2009)
32
4.2 Quality assessment
To decide over the quality of the 21 included clinical studies, a systematic assessment list
that has been previously used by other authors’ systematic reviews (Hayashi and Yeung,
2003) (Pol and Kalk, 2011) regarding ceramic inlays, has been used. The above list is
consisting of 24 questions, which have been developed with the help of the Cochrane
Health Group, assess the quality of each aspect of the included study and evaluates the
scientific power of these studies providing the author with a tool that can distinguish the
well conducted papers from those that are poorly organized.
Table 1 Study's quality assessment form-Questions to be answered
1 Are the hypotheses/aims/objectives clearly described?

2 Is the setting of the study or the source of the subjects studied described?
3 Is the distribution of the study population by age or sex described?
4 Are the inclusion criteria stated?
5 Are the exclusion criteria stated?
6 Are the treatments (sequence and steps) well described?
7 Are the main outcomes to be measured clearly described in the “Introduction or
“Methods” section?
8 Is the sample size stated?
9 Was the sample size justified?
10 Was the concurrent control group used?
11 Was random allocation to treatment used?
12 Was the method of random allocation given?
13 Was blind assessment of the outcome carried out?
14 Was there more than one examiner for outcome assessment?
15 Was examiner calibration carried out?
16 Are the statistical methods described?
17 Is the participation /follow-up rate stated?
18 Was the participation /follow-up rate greater than 80%
19 Are the non participants /subjects lost to follow-up described?
20 Are the main findings of the study clearly described?
21 Are results stated in absolute numbers instead of percentages when feasible?
22 Are confidence intervals given?
23 Are any important adverse events reported?
24 Are any conclusions stated
33
While on the previous systematic reviews either abstracts or full texts have been used for
the quality assessment and full text only for the final data analysis, in the present review it
was decided as more fair and effective to use only full text for the quality assessment of all
the articles. In order to calibrate the ability of the assessor four random studies were
chosen, two of each of the previous systematic reviews, and the results were compared
with those included in the original quality assessment forms.
Table 2 Study's quality assessment form-Answers to the questions I

Study Study 1 2 3 4 5 6 7 8 9 10 11 12
type
RCT Manhart et al. 2001 + + + + +
RCT Thordrup et al + + + + + + + + +
RCT Huth et al. + + + + + + + + + + +
RCT Pallessen and Qvist + + + + + + + + + +
RCT Alhadainy et al. + + + + + + + + + +
RCT Fasbinder et al. + + + + + + + + +
RCT Spreafico et al. + + + + + + + + + +
RCT Wassell et al. + + + + + + + + + +
RCT Gladys et al. + + + + + + + + +
CCT Mendonca et al. + + + + + + + + + +
CCT Dukic et al. + + + + + + + + +
CCT Manhart et.al 2000 + + + + +
CCT Kaytan et al. + + + + + + + +
CCT Jung et al. + + + + + + +
CCT Donly et al. + + + + + + + + +
CCT Kukrer et al. + + + + + + + +
CCT Dijken + + + +
CCT Cetin and Unlu + + + + + + + + + +
CS Leirskar et al.2003 + + + + +
CS Krejci et al. + + + + +
CS Bessing and Lundqvist + + + + + +
CS Yilmaz and Gemalmaz + + + + +
CS Barone et al. + + + + + +
34
Table 3 Study's quality assessment form-Answers to the questions II
Study Study 13 14 15 16 17 18 19 20 21 22 23 24
type
RCT Manhart et al. 2001 + + + + + + +
RCT Thordrup et al + + + + + + + +
RCT Huth et al. + + + + + + + + +
RCT Pallesen and Qvist + + + + + + + + +
RCT Alhadainy et al. + + + + + + + +
RCT Fasbinder et al. + + + + + + + +
RCT Spreafico et al. + + + + + +
RCT Wassell et al. + + + + + + +
RCT Gladys et al. + + + + + + +
CCT Mendonca et al. + + + + + + + +
CCT Dukic et al. + + + + + + +
CCT Manhart et.al 2000 + + + + + + + + +
CCT Kaytan et al. + + + + + + +
CCT Jung et al. + + +
CCT Donly et al. + + + + +
CCT Kukrer et al. + + + + + + + +
CCT Dijken + + + + + + + + +
CCT Cetin and Unlu + + + + + + +
CS Leirskar et al.2003 + + + + +
CS Krejci et al. + + + + + + +
CS Bessing and Lundqvist + + + + + +
CS Yilmaz and Gemalmaz + + + + +
CS Barone et al. + + + + + + + +
35
4.3 Characteristics of the included studies-Data extraction
After conducting this quality assessment table, it was decided to use only RCTs and CCTs
because of the low scientific validity of the case series. To evaluate composite inlays we
could use articles comparing composite to porcelain and gold as restorative material as
well as articles comparing direct restorations to indirectly constructed inlays. Data related
to failure rates, postoperative sensitivity and aesthetic quality were extracted. The protocol
that has been previously used by Hayashi was followed so as failure was regarded the
replacement of the restoration, appearance of endodontic problems or clinically
unacceptable restorations according to USPHS criteria (Charlie and Delta scores).
Postoperative sensitivity, was regarded the sensitivity to temperature or to occlusal load, up
to one month after the placement. Finally aesthetic quality was regarded as the absence of
colour match or marginal discolouration according to the clinical criteria of USPHS
(Charlie and Delta scores). Data on the comparison of the clinical effectiveness (related to
the previously mentioned characteristics) between premolars-molars and small-large
cavities were also extracted.
36
Table 4 Huth 2011
Methods Participants Intervention Outcomes Results

Study design: Participants:89 Groups: Measure: Recall rate:
RCT Number of restorations:155 1)75 Artglass composite inlays Modified USPHS criteria 52% for the Artglass inlays
Parallel design Age:21-72(mean age 39.4) 2)80 Charisma composite inlays -Surface texture 59%for the Charisma inlays
Aim: Clearly stated Sex: Not stated -Artglass inlays luted with Twinlook or -Colour match Statistical analysis:
Randomization: Yes Sealed envelopes Inclusion criteria: 2bond2 -Anatomic form Mann-Whitney U-test
used for allocation concealment. -Age>18yrs -Marginal integrity Fisher’s exact test
Outcome assessment: Two -Regular dental attendees Clinical procedure: -Discolouration of the margin Longevity:
independent and calibrated -Written consent -Twenty-one trained supervised -Integrity of the tooth and restoration Failure rate
investigators -High level of OH student operators -Occlusion Group1)12.8%
Power calculation: not performed -Premolars or molars that are vital, in -All made by technician following -Testing of sensitivity Group2)23.4%
Blind assessment: Half blind design. occlusion -Isthmus manufacturer’s instructions -Postoperative symptoms Esthetic quality:
The 2 clinicians do not have any size>1/2intercuspal distance -Postcured in light oven for 10min All were acceptable for Artglass but 6
information about the type they Exclusion criteria: Follow up: non-acceptable for Charisma
examined -Irregular attendees -6 months Postoperative sensitivity:
Ethical approval: Approved by Ethics -Severe diseases, allergies -1,2,3,4 years Group1)4/96
committee -Severe gland dysfunction Group2) 5/95
-Groups almost equally balanced -Unacceptable OH scored B. Not significant sensitivity
between the 2 interventions. -Severe perio problems -Small inlays compared to large and
-Confidence limits not provided -Non vital, painful premolars compared to molars showed
Potential Bias: -Only initial defects better outcome for Artglass but not for
-Sponsored by Dental factory Setting: Patients at Munich dental Charisma .No significant difference
-Inlays placed by dental students school regarding failure.
37
Table 5 Fasbinder 2005

Study design: RCT Participants:43 Groups: Measure: Recall rate:
Parallel design Number of restorations:80 1)40 resin-based composite Modified by University of Michigan Overall 89%
Aim: Clearly stated Age: Not mentioned inlays(Paradigm) USPHS criteria 34/40 ceramic inlays
Randomization: Sex: Not mentioned 2)40 Porcelain inlays (Vita markII) -Colour match 37/40 composite inlays
Yes, but does not mention the way of Inclusion criteria: -Anatomic form Statistical analysis:
the randomization. Allocation -At least one two/three surface carious -Margin discolouration ,finish and Wilcoxon signed rank test
concealment by sealed envelopes. lesion or restoration Clinical procedure: adaptation
Outcome assessment: Two -Size>1/2 intercuspal width -Both have been constructed using -Surface finish Longevity: No clear conclusions have
independent evaluators. -Teeth in functional occlusion, vital CAD-CAM CerecII. -Cusp/tooth fracture been stated for survival
Power calculation: Not performed and asymptomatic. -Clinicians constructed them chairside -Caries Esthetic quality:
Blind assessment: Not reported -Zero restoration the past 12 months and luted them at the same -Restoration fracture Colour match: significant difference
Ethical approval: Exclusion criteria: appointment. -Proximal contact between the two materials in (alpha
Approved by University of Michigan -Non-vital, sensitive teeth scores) at 3 years,
review board -Prior endo Follow up: 86.5%of resin-based and 58.8 % of the
-Confidence limits not provided -Prior pulp capping -6months porcelain rated alpha.
-groups equally balanced between -Significant untreated dental disease -1 ,2,3 years Marginal discolouration:83.8%,91.2%
interventions Setting: respectively
Potential Bias: Not clearly stated ,probably University Postoperative sensitivity:
-Only low caries risk patients have of Michigan -All sensitivity resolved by two weeks
been used for both
-Two symptomatic resin inlays were
changed to ceramic inlays
-One operator participated in the recall
evaluation.
38
Table 6 Wassell 2000

Split mouth design Number of restorations: 100 pairs 100 pairs of inlays and conventional USPHS criteria 65 out of 100 pairs
Aim: Clearly stated Age: 29.6 ± 10.3 years restorations made from Brilliant Dentin -Surface roughness Statistical analysis:
Randomization: Sex: 54 female- 19 male -Colour match analysis for significant differences
Three levels of randomize allocation Inclusion criteria: Clinical procedure: -Marginal adaptation between 2 restorations
using a random number table. -At least 1 pair on each participant of -Inlays were directly builded -Secondary caries Longevity:
Outcome assessment: similar cavity type and size intraorally and then removed and re- Overall failure rates 12.5% at 5 years
Two calibrated examiners Exclusion criteria: cured at 120 C over an 8 min cycle, Follow up: -17.4% for the inlays and 7.5% for the
Power calculation: -They could not attend recall polished and 39cemented Every six months up to five years conventional. Not significant
Not performed -Poor oral hygiene ,unresponsive to difference ( 2.39,d.f.=1,P>0.05)
Blind assessment: instructions Esthetic quality:
Partly blinded. Examiner was blind to Spontaneous gingival bleeding No apparent deterioration of colour
other’s restorations -Subgingival margin of 3 mm or more match at 5 years.
Ethical approval: -Potentially 1 functional and 2 non- 30% of the inlays and 35% of the
Obtained by the University’s Ethic functional cusps conventional showed marginal
committee. Setting: discolouration.
-Groups equally balanced between the Unclear location ,possibly University Postoperative sensitivity:
2 interventions. Not reported according to time
-Confidence limits not provided -All failures except one occurred at
Potential Bias: large restorations
-Operators participated as examiners
-Not really indirect inlays
-Drop-outs were not included
-Support by manufacturer
39
Table 7 Thordrup 2006

Study design: RCT Participants:37 Groups: Measure: Recall rate:41 out of 58
Split mouth +parallel design Number of restorations:58 1)15 direct ceramic inlays (Cerec II) CDA index assessments for Statistical analysis:
Aim: Clearly stated Age:23 -69 2)14 indirect ceramic inlays(Vita dur- -Marginal adaptation Log rank tests and
Randomization: Yes but Sex:7men and 30 women N) -Morphology Chi-square tests with P< 0.05 as the
randomization procedure and Inclusion criteria: 3)15 direct composite inlays(Brilliant -Colour match significance level
allocation concealment not reported. -1to 4posterior teeth with large MOD DI) -Surface texture
Outcome assessment: restorations for replacement 4)14 indirect composite inlays(Estilux) -Sensitivity and discomfort Longevity:
Operator and patients’ own dentist on Exclusion criteria: -Proximal contact points Survival rate without repair
some occasion. -Clenching, bruxism, severe Group1)80%
Power calculation: not performed malocclusion Clinical procedure: Follow up: Group2)61.9%
Blind assessment: not performed -Gingival inflammation,periodontitis, -Bulk technique has been used for the -6months Group3)66.7%
Ethical approval: not stated poor OH direct composites -1,3,4,5,10 years Group4)50.8%
-Groups equally balanced between the -Partial dentures -Heat and light curing for indirect Esthetic quality:
4 interventions. -High caries progression -Similar cementation procedures for all Colour match: After 10 years all types
-Confidence limits not provided Setting: showed a decreased frequency of
Potential Bias: Possibly various locations perfect ratings
-Clinician participated as examiner
-Non calibrated patient’s dentist Postoperative sensitivity:
participated as assessors Not reported
-Repaired inlays were included
40
Table 8 Spreafico 2005

Split-mouth design Number of restorations:44 1)22 direct restorations Modified USPHS criteria for 100%
Aim: Clearly stated Age:18-27 2)22 semi-direct restorations (both -Post-operative sensitivity Statistical analysis:
Randomization: Yes but Sex:7 females -4 males made with fine-hybrid composite -Restoration and cavosurface integrity Mann Whitney U
randomization process and allocation Inclusion criteria: A.PH) -presence of secondary caries Friedmann, Wilcoxon
concealment not stated -Good OH and periodontal health -Wilcox tests
Outcome assessment: -Presence of antagonists Clinical procedure: Follow up: Longevity:
Not stated .Possibly the operator -Normal proximal contacts -Incremental placement of the -14 days No failure was detected
Power calculation: -Primary similar carious lesions in 2 composite for the direct restorations -9 months Esthetic quality:
Not performed contra lateral teeth of the same upper -Chairside pouring of the impression in -3.5 years Not reported
Blind assessment: Not performed jaw fast setting hard silicone Postoperative sensitivity:
Ethical approval: Not performed -Cavity size<2/3 of the intercuspal -Light and heat cure for 7 min at 120 Reported for one direct and two
-Groups equally balanced between the distance. C. indirect inlays
2 interventions. Exclusion criteria: -Luted with dual-curing light cement
-95% confidence level Not reported
Potential Bias: Setting:
-Possibly operator was also the Private practice
examiner (not clear)
41
Table 9 Pallessen 2003

Study design: RCT Participants:28 Groups:28 each Measure: Recall rate:
Split-mouth design Number of restorations:140 1)Composite filling in Brilliant Dentin Modified USPHS criteria One patient-5 restorations could not
Aim: clearly stated Age:19-64 2)Composite filling in Estilux -Surface texture been evaluated
Randomization: Yes. Casting dice has Sex:20 females/8 males 3)Indirect inlay in Brilliant Dentin -Colour match Statistical analysis:
been used only for the selection of the Inclusion criteria: 4)Indirect inlay in Estilux -Anatomic form -Friedman two-way analysis of
brand -Patients required 5 aesthetic 5)Indirect inlay in SR-Isosit -Marginal adaptation variance by ranks
Outcome assessment: restorations of equivalent medium to -Discolouration of the margin -Chi-squared tests with P<0.05
Calibrated evaluators large size. Clinical procedure: -Secondary caries Longevity:
Power calculation: -Faciolingual dimension>1/3 of -Manufacturers’ instructions were Fillings:16%failed
Not performed intercuspal distance followed Follow up: Inlays:17% failed
Blind assessment: -Vital teeth -All indirect inlays were postcured in -2,5,8,11years Esthetic quality:
Not performed -No preoperative symptoms an oven Rated as optimal or acceptable
Ethical approval: Not stated -Functional occlusion -Colour match~33% of the fillings and
-Groups equally balanced between the -Adjacent teeth 44% of the inlays
5 interventions. Exclusion criteria: -Marginal discolouration~26% of the
-Confidence limits not provided Not stated fillings and 50% of the inlays
Potential Bias: Setting: Postoperative sensitivity:
-Way of randomization between filling Possibly University of Copenhagen -7% restored with fillings and 10 %
and inlay not stated with inlays
-Operator participated in evaluation -7% of the premolars and 12% of the
-Drop-outs were not concerned for the molars showed post operative
final results. symptoms at 1 month baseline
assessment.
-14%of the fillings and 20%of the

inlays in molars had failed while 5%
and 8% respectively had failed in
premolars
42
Table 10 Alhadainy 1998

Parallel design Number of restorations:50 1)25 composite inlays on molars luted Modified USPHS criteria 84%
Aim: Clearly stated Age:20-40 with All-Bond2 bonding agent -Recurrent caries Statistical analysis:
Randomization: Yes, coin toss has Sex: not stated 2)25 composite inlays on molars luted -Postoperative sensitivity Chi-square test
been used to distribute the restorations Inclusion criteria: with Geristore bonding agent -Gingival conditions Longevity:
equally. Allocation concealment not -At least 2 teeth with amalgam No inlay showed restoration fracture,
reported restorations required repair. Clinical procedure: Follow up: tooth fracture or recurrent caries
Outcome assessment: -Class II with isthmus<1/2 of Indirect composite inlays builded -baseline Esthetic quality:
Two independent calibrated evaluators intercuspal distance indirectly on a cast and light cured for -6 months Group1)Alfa score in 81% for colour
Power calculation: Not performed -Molars free from periodontal disease, 60 sec occlusally and from the bottom. -12 months match and 61.9% for cavosurface
Blind assessment: Not performed pulpal involvement or malocclusion. -24 months discolouration
Ethical approval: Not reported -Functional teeth opposing Group2) Alpha score in 85.7% for
-Groups equally balanced between the Exclusion criteria: colour match and 76.2%for
2 interventions. Not reported cavosurface discolouration.
-Confidence limits not provided Setting: Postoperative sensitivity:
Potential Bias: Volunteers possibly from the Two teeth in one patient showed
-Some amalgam was retained University postoperative hypersensitivity.
43
Table 11 Gladys 1995

Parallel design Number of restorations:32 1)8 ceramic inlays Cerec-Dicor Results were recorded with the 100%
Aim: Stated but not very clearly Age:20-25 MGC index system described by Vanherle Statistical analysis:
Randomization: Yes, but the Sex: not stated 2) 8 ceramic inlays Cerec-Vita Mark related with: -Kruskal-Wallis one way analysis of
randomization process and allocation Inclusion criteria: I cemented with Pontic C -Caries recurrence variance
concealment not stated Not stated 3) 8 ceramic inlays Cerec-Vita Mark -Vitality -Wilcoxon-Mann-Whitney test, Bonferroni
Outcome assessment: II cemented with Duo cement -Marginal adaptation correction significance level of P<0.01
Two independent and calibrated clinicians Exclusion criteria: 4)8 composite inlays P-50 -Marginal discolouration Longevity:
Power calculation: Not stated -Surface roughness All restorations were clinically acceptable.
Not performed Setting: Clinical procedure: -colour stability, translucency and No recurrent caries, no changes in vitality.
Blind assessment: Dental students volunteers -Following manufacturer’s opacity Esthetic quality:
Not performed instructions -No marginal discolouration was detected
Ethical approval: Approved by the local -post –cure for 5min at 120 C -Overall 71%showed excellent colour
Ethics committee. Follow up: match.
-Groups equally balanced between the 4 -6 months -Rest slightly opaque.
interventions. -3 years Group1:25%opaque
-Confidence limits not provided Group4:100%opaque
Potential Bias: Postoperative sensitivity:
-Small sample Not reported
-Only young patients
44
Table 12 Manhart 2001

Study design:RCT Participants:45 Groups: Measure: Recall rate:
Parallel design Number of restorations:71 1)47 Composite inlays Modified USPHS criteria 87%
Aim: Clearly stated Age:23-58 a.Tetric -Surface texture Statistical analysis:
Randomization: Sex: not reported b.blend-a-lux -Colour match -Pearson’s correlation coefficient
Partially only between the three types Inclusion criteria: c.Pertac-hybrid unifil -Anatomic form -Mann -Whitney U test
of composite used -Failed restorations or primary caries 2)24 Ceramic inlays-IPS empress -Marginal integrity -Fischer’s exact test
Outcome assessment: -Discolouration of the margin Longevity:
Two independent ,calibrated Exclusion criteria: -Integrity of the tooth and restoration Group1)Success rate of 89%
examiners Not reported Clinical procedure: -Occlusion (4 failed)
Power calculation: Setting: -Manufacturers’ instructions followed -Testing of sensitivity Group2)Success rate of 100%
Not performed -Munich Dental School -Composite inlays were postcured for -Postoperative symptoms Esthetic quality:
Blind assessment: Half- blind -Seven student operators in their third 10 min Colour match-clinically accepted at 3
Ethical approval: clinical period -Dual cure luting composite Variolink Follow up: years, no Charlie or delta. Similar
-Groups not equally balanced has been used for all the inlays -baseline number of alphas for both
between the 2 interventions. -1 ,2,3 years interventions. Same results for margin
-Confidence limits not provided discolouration.
-No randomization between inlays No postoperative symptoms at
and fillings baseline
-No allocation concealment
-Placed by dental students -All composite failures were on
-Only ceramic inlays placed in large molars
cavities -Statistically significant superior
-Different composites (brands)can be results for some characteristics on
a possible bias for the outcome we premolars
study -Better marginal integrity and less
discolouration for small inlays
45
Table 13 Van Dijken 2000

Study design: CCT Participants:40 Groups: Measure: Recall rate:
Parallel design Number of restorations:134 1)100 direct composite Modified USPHS criteria -96% of the inlays
Aim: Clearly stated Age:27-70 (mean age 48) inlays(Brilliant) -Surface roughness -3% of the direct
Randomization: Sex:24 male-16 female 2)34 direct composite -Colour match Statistical analysis:
Not performed Inclusion criteria: restorations(Fulfil) -Anatomic form Fisher exact test
Outcome assessment: -Teeth in occlusion, with at least one -Marginal adaptation Longevity:
Two calibrated evaluators proximal contact Clinical procedure: -Discolouration of the margin Failure rate
Power calculation: -Replacements of old amalgam fillings -Inlays directly constructed ,removed -Caries -17.7% of the inlays
Not performed Exclusion criteria: post-cured in light-heat oven for 7 min -27.3% of the fillings
Blind assessment: Not stated at 120 C Follow up: Esthetic quality:
Not stated Setting: -Annually until 11 years No inlay or filling was rated as
Ethical approval: Not reported unacceptable for colour match and
Not stated marginal discolouration
-Groups not equally balanced between Postoperative sensitivity:
the 2 interventions. Not reported
-Confidence limits not provided
Potential Bias:
-Inlays intraorally constructed -No rates were given for differences
-Drop-outs not included in results between premolars/molars and
small/large inlays.
46
Table 14 Donly 1999
Study design:CCT Participants:18 Groups: Measure: Recall rate:
Split-mouth design Number of restorations:54 1)18 composite inlays made from Modified USPHS criteria 45%
Aim: Clearly stated Age:22-47 Concept, cemented with Heliobond -Surface texture Statistical analysis:
Randomization: No Sex: not stated 2) 18 composite inlays made from -Colour match not applicable for gold Chi-square test P<0.05
Outcome assessment: Inclusion criteria: Concept, cemented with -Marginal integrity Longevity:
1 examiner and 1 trained recorder -Health histories Special Bond -Interfacial staining Overall:78%
Power calculation: -Intraoral and extraoral conditions 3)18 Gold inlays -Secondary caries Group1)72%
Not performed within normal limits -Wear Group2)78%
Blind assessment: -Each individual needed at least three Clinical procedure: -Axial contour and contact Group3)83%
Half-blind. Examiner could not posterior restorations -Manufacturers’ instructions have been -Postoperative sensitivity Composite inlays total:75%
visualize the recording form Exclusion criteria: followed Esthetic quality: Colour match for
Ethical approval: Approved by the Not reported Follow up: Composites:64% scored alpha,11%
Collegiate Internal Review Board Setting: -7 years scored Bravo and 25% not checked
-Groups equally balanced between the -Human volunteers recruited from Postoperative sensitivity:
3 interventions. advertisements and School of dentistry Initially 3 % overall
-Confidence limits not provided Iowa.
Potential Bias: -9 molar restorations failed
-No allocation concealment (2gold+7composite)
-Very low recall rate (45%) and 3 premolar restorations(1gold and
-Support by manufacturer 2 composite)
-Partially recruited through
advertisements (selection bias)
-Drop-outs were not included in final
results
47
Table 15 Manhart 2000

Study design:CCT Participants:45 Groups: Measure: Recall rate:68%
Parallel design Number of restorations:88 1)43 direct composite restorations Modified USPHS criteria Statistical analysis:
Aim: Clearly stated Age: not reported 2)45 indirect composite inlays -Surface texture -Pearson’s correlation coefficient
Randomization: Sex: not reported (Tetric,blend-a-lux,Pertac-hybrid -Colour match -Mann Whitney U test
Generally no. Only between the Inclusion criteria: Unifil) -Anatomic form -Fisher’s test
students. -Single or multisurface cavities of -Marginal integrity Longevity: Overall 5 were Delta
Outcome assessment: premolars and molars -Discolouration of the margin scored
Two independent calibrated examiners Exclusion criteria: Clinical procedure: -Integrity of the tooth and restoration Rated alpha or bravo
Power calculation: Not reported -Manufacturers’ instructions were -Occlusion Group1)87%
Not performed Setting: followed -Testing of sensitivity Group2)93%
Blind assessment: Half blind design Munich dental school -Students constructed the inlays under -Postoperative symptoms Esthetic quality:
Ethical approval: Not reported Nine student operators technician’s supervision -No significant difference for colour
-Groups equally balanced between the -Inlays postcured for 10 min in light Follow up: match and for discolouration of the
2 interventions. oven -baseline margin.
-Confidence limits not provided -1,2,3years Postoperative sensitivity:
Potential Bias: No postoperative symptoms reported at
-Restorations were placed according to baseline. No clear when was that
cavity’s size
-Students (on 1st clinical period) were -4 molars and only 1premolar failed
the operators. -Significant better results for some
-Small sample sizes parameters on premolars than molars
-Drop-outs were not included in the but no discrimination between inlays
results and fillings
-Different composites (brands)can be a
possible bias -Significant difference in small cavities
48
Table 16 Kukrer 2004
Parallel design Number of restorations:99 1)43 Composite(Targis) inlays luted Modified USPHS criteria 100%
Aim: Clearly stated Age: mean age 27.3 with Variolink Ultra -Surface roughness Statistical analysis:
Randomization: not performed Sex:32 females and 19 males 2)56 Composite (Targis) inlays luted -Colour match Kaplan Meier
Outcome assessment: Inclusion criteria: with Variolink II high Viscosity -Anatomic form Longevity:
Two calibrated observers -Periodontally healthy patients with -Marginal adaptation Overall 97.9% rated satisfactory at the
Power calculation: Not performed high level of oral hygiene -Discolouration of the margin mean evaluation period
Blind assessment: Exclusion criteria: Clinical procedure: -Caries Group1)97.7%
Not reported Not stated -Manufacturers’ instructions followed Group2)98.2%
Ethical approval: Setting: Follow up: Esthetic quality:
Not stated Not stated -6 to 53 months (mean27.6 months) Colour match and marginal
-Groups not equally balanced between discolouration was rated acceptable for
the 2 interventions. all the restorations
-Confidence limits not provided Postoperative sensitivity:
Potential Bias: 6% and 7% of the vital teeth displayed
-Recall time was not fixed and was postoperative sensitivity to thermal
unevenly distributed. effects and on biting respectively
-29% of the restorations placed in
patients with parafunctional habits -No rates were given for differences
between premolars/molars and
small/large inlays.
49
Table 17 Mendonca 2010

Study design: CCT Participants:30 Groups: Measure: Recall rate:
Parallel design Number of restorations:76 1)44 direct composite fillings(Tetric Modified USPHS criteria 100%
Aim: Clearly stated Age:18 to 45 (mean age 29.8) Ceram-TC) -Surface texture Statistical analysis:
Randomization: not performed Sex: 15 male and 15 female 2)32 indirect composite inlays (Targis -Colour match -Fischer
Outcome assessment: Inclusion criteria: TG) -Anatomic form -McNemar chi-square test with p<0.05
Two independent calibrated examiners -Free of major diseases -Marginal integrity Longevity:
Power calculation: -Periodontally sound with normal Clinical procedure: -Discolouration of the margin 100% clinically acceptable
According to ADA for testing a new occlusion -Manufacturer’s instructions were -Pulp sensitivity Esthetic quality:
material -At least two posterior restorations followed -Postoperative symptoms For colour match
Blind assessment: needed either caries or old restoration -Secondary caries Group1)100% alpha ratings
Not performed -No pulpal involvement or Group2)96.88% alpha ratings
Ethical approval: malocclusion Follow up: For marginal
-Groups not equally balanced between Exclusion criteria: -1year discolouration: statistical significant
the 2 interventions. -Not stated difference after 1 year but no
-Confidence limits not provided Setting: difference between direct and indirect
Potential Bias: -Patients were volunteers Postoperative sensitivity:
-No allocation concealment -Most of them are police officers Group1)6.66%
-Only one year results recruited at the Bauru dental School Group2)15.62%
-No rates were given for differences

between premolars/molars and
small/large inlays.
50
Table 18 Cetin 2009
Split mouth Number of restorations:100 1)20 fillings with Filtec Supreme Modified USPHS criteria 100%
Aim: Clearly stated Age:20-28 (mean age 23) composite -Surface texture Statistical analysis:
Randomization: not performed Sex:22 male and 32 female 2)20 fillings with TetricEvo composite -Colour match -Fisher’s exact test
Outcome assessment: Inclusion criteria: 3)20 fillings with Aelite composite -Marginal integrity -McNemar chi-square test
Two independent ,not calibrated -Two cavities, class I or class II 4)20 inlays with Estenia composite -Discolouration of the margin Longevity:
examiners -All enamel margins 5)20 inlays with Tescera composite -Postoperative sensitivity 100% clinically acceptable
Power calculation: -In occlusion -Gingival adaptation Esthetic quality:
In accordance with ADA for testing -No pulp exposure Clinical procedure: -Retention All were rated as acceptable. Not
new material Exclusion criteria: -Manufacturer’s instructions were significant difference regarding colour
Blind assessment: -Faciolingual isthmus <2/3 followed Follow up: match and marginal discolouration
Not stated Setting: -A technician made all the inlays -6,12 months Postoperative sensitivity: No
Ethical approval: -Routine patients of the dental school -Additional curing in a light oven and statistical significant difference
Ethics committee of the University -Volunteers from staff, students and in heat oven was carried out
-Groups equally balanced between the members of their families
5 interventions. -All restorations were on molars
-Confidence limits not provided
Potential Bias:
-More of the class I were restored
directly (37 to 12) and more of the
class II indirectly
-Not calibrated investigators
-Only one year results
51
Table 19 Dukic 2010

Study design: CCT Participants:51 Groups: Indirect composite Measure: Recall rate:88.23% after 36 months
Aim: Clearly stated Number of restorations:71 restorations Modified USPHS criteria and 11.76% came one month after
Randomization: Age:16 to 23 1)Builded with Admira -Surface texture Statistical analysis:
Not performed Sex: 32 male and 19 female 2)Builded with Grandio -Colour match -Mann-Whitney test
Outcome assessment: Inclusion criteria: -Anatomic form -Wilcoxon signed-rank test
One independent, not calibrated -Large ,multi-surfaced cavities Clinical procedure: -Marginal integrity Longevity:
examiner involving at least one cusp -Manufacturer’s instructions were -Discolouration of the margin 100% success rate for both
Power calculation: Exclusion criteria: followed -Integrity of the tooth and restoration (acceptable).
Not performed -Hypersensitive pulp reaction -One dentist prepared, manufactured -Occlusion -Group1:70.7% graded Alpha1
Blind assessment: -Direct pulp capping and placed all the restorations -Testing of sensitivity Group2:71.8% graded Alpha2
Half blind -Root canal therapy -Postoperative symptoms Esthetic quality:
Ethical approval: Setting: -Patient compliance For colour match:
Not reported Routine patients in the dental clinic, All were rated as acceptable.5% of
-Groups equally balanced between the volunteer patients, dental staff and Follow up: Group1 received Bravo
2 interventions. members of their families -36 months For marginal
-Confidence limits not provided discolouration: All were rated as
Potential Bias: acceptable Alpha
-Only one ,not calibrated examiner Postoperative sensitivity:
-Only molars have been used Not reported
-Alpha class have been modified to
two divisions All were used on large cavities of
-Only young patients molars.
52
Table 20 Kaytan 2005

Study design: CCT Participants:47 Groups: Measure: Recall rate: 93.6%
,split mouth design Number of restorations: 94 1)Ceramic onlays (Empress) Modified USPHS criteria Statistical analysis:
Aim: Clearly stated Age: 23 to 49 2)Indirect composite onlays (Soll-dex) -Surface texture -Chi-square
Randomization: Sex:33 female and 14 men -Colour match -Fisher’s exact
Not performed Inclusion criteria: Clinical procedure: -Anatomic form -Cohran’s Q
Outcome assessment: -Severely destroyed teeth -Manufacturer’s instructions were -Marginal adaptation -McNemar test with Bonferoni
Two independent, not calibrated -Dentin caries followed -Discolouration of the margin correction
examiners -Secondary caries -One technician manufactured and one -Postoperative symptoms Longevity:
Power calculation: -Non-esthetic restorations dentist placed all the restorations One onlay failed
Not performed Exclusion criteria: Follow up: Esthetic quality:
Blind assessment: -Clenching -6,12,18,24 months For colour match:
Not performed -Bruxism Significant difference between
Ethical approval: -Severe malocclusion composite and ceramic
Ethical guidelines according to -Severe or chronic Periodontitis Alpha ratings after 24 months:
Helsinki declaration applied -Poor oral hygiene Group1:90.2%
Setting: Group2:60%
-Groups equally balanced between the -Patients admitted in the University For marginal
2 interventions. clinic discolouration:
-Confidence limits not provided no significant difference
-Only molars have been used Group1)19%
Group2)24%
53
After listing the important characteristics of the included articles we can decide which of
them can be used to answer each one of the hypotheses. Furthermore 1 RCT (Alhadainy et
al., 1998) and 2 CCTs (Dukic et al., 2010, Kukrer et al., 2004) could not answer none of
the questions because they were comparing composite inlays between each other and did
not make any comments concerning differences between premolars-molars and small-large
inlays. See appendix 6 for a list of the 21 different types and brands of composite that have
been used including manufacturer and composition.
4.4 Effects of interventions
4.4.1 Composite inlays vs ceramic and gold
Regarding the differences between composite and ceramic inlays 4 RCTs and 1CCT can be
used whereas only 1 CCT is available to examine differences between composite and gold.
Table 21 Studies comparing composite vs ceramic and gold
1 RCT Fasbinder et al 2005

2 RCT Thordrup et al 2006
3 RCT Gladys et al 1995
4 RCT Manhart et al 2001
5 CCT Kaytan et al 2005
6 CCT Donly et al 1999
4.4.1.1 Longevity analysis
Fasbinder (Fasbinder et al., 2005) in his study used CAD-CAM technology to construct 40
porcelain and 40 composite inlays and observed their features for a three years period. He
states that 1 ceramic and 2 composite inlays needed replacement; however he kept some of
the fractured inlays in situ as they were asymptomatic and replaced two fractured
composite inlays with ceramic. Thus his estimation on survival rates of inlays is unclear.
Likewise Thordrup (Thordrup et al., 2006) used Cerec fabricated and indirect ceramic
inlays in comparison with direct and indirect composite inlays for a ten year period. He
54
provides the reader with two versions of survival rates, with and without repairs. Although
the survival rates without repairs are 80% and 61.9% for Cerec and Vita dur inlays
respectively while is 50.8% and 66.7% for Estilux and Brilliant DI composite inlays,
author supports that there is no statistically significant difference between the inlays for
both versions. Apart from that, some of the repairs and the evaluations have been made by
patients’ own dentist, making his conclusions biased. Gladys (Gladys et al., 1995) similarly
constructed with Cerec three different types of ceramic inlays and a composite inlay as
control for three years observation time. Although he used a different index system
(Vanherle et al., 1986), he found all the evaluated inlays clinically acceptable at the 3-year
recall, however the composite that they used as a control was experimental at that time and
not in use any more. Manhart on the other hand (Manhart et al., 2001) studied the
performance of three different composite inlays in comparison with one ceramic for three
years and found insignificant difference between them. However he used ceramic for large
cavities and composite for small cavities which is considered as a selection bias. Finally,
insignificant difference was observed by Kaytan in his non-randomized control trial
between composite and ceramic onlays in a split mouth study after a short two years period
of observance (Kaytan et al., 2005). A later recall could give us more usable results.
In the only available trial comparing composite and gold (Donly et al., 1999) for the
construction of inlays the survival rates were 75% and 83% after seven years respectively,
which indicates an insignificant difference between the two materials although the recall
rate is only 45 %.
4.4.1.2 Esthetic quality
Regarding the aesthetic quality two different parameters were evaluated, colour match and
marginal discolouration. In the first trial (Fasbinder et al., 2005) only alpha scores are
reported for colour match and marginal discolouration. For colour match, porcelain scored
85% at baseline because of the use of monochromatic blocks for Cerec and 58.8% after 3
years, while composite started at 100% and went down to 86.5% at the 3 years recall which
indicates a significant difference test, P<0.05). On the other hand considering
marginal discolouration there was no significant difference ( test, P=0.945) between
porcelain and composite because they both started at 100% and went down to 91.2% and
83.8% after 3 years respectively. In the second trial (Thordrup et al., 2006) a decrease in
perfect ratings is reported which is not particularly valuable because part of the evaluations
have been made by patients’ own dentist without any calibration. In the RCT by Gladys
and co-workers (Gladys et al., 1995), no marginal discolouration was detected but findings
55
on colour match are controversial speaking at the same time of excellent colour match and
100% opaque in the composite group. In the other RCT both colour match and marginal
discolouration were clinically acceptable at 3 years (Manhart et al., 2001) while Kaytan
found significant difference in colour match after 2 years in favour of ceramic and
insignificant difference in discolouration of the margin (Kaytan et al., 2005).
4.4.1.3 Postoperative sensitivity
No sensitivity was reported for either composite and porcelain in the first RCT (Fasbinder
et al., 2005) and in the second RCT (Manhart et al., 2001) postoperatively but there were
no reports on that aspect in the two other studies. Extremely high sensitivity, 24% and 19%
for composite and ceramic respectively, is reported by Kaytan (Kaytan et al., 2005) at
baseline which is said to be reduced in follow recalls although it is not stated which
percentage of it remained at the month recall which is important in the present review. No
comparison can be made between composite and gold because in the only available article
on the subject they report a 3% postoperative sensitivity but they do not differentiate the
two groups’ scores (Donly et al., 1999).
4.4.2 Composite inlays versus direct composite fillings
The following articles are available to answer the second hypothesis.
Table 22 Composite inlays vs direct composite fillings
1 RCT Wassell et al 2000

2 RCT Spreafico et al 2004
3 RCT Pallessen and Qvist 2003
4 CCT Manhart 2000
5 CCT Van Dijken 2000
6 CCT Mendonca 2010
7 CCT Cetin 2009
56
4.4.2.1 Longevity
In the first RCT Wassell placed 100 pairs of composite fillings and inlays and found after
five years 7.5% and 17.4% failure rate respectively which is reported as an insignificant
difference between the two interventions (Wassell et al., 2000). No failure was detected in
the second RCT after 3.5 years for 22 direct fillings and 22 indirect inlays (Spreafico et al.,
2005). Similar findings are reported by the 11 year studies of Pallessen (Pallesen and
Qvist, 2003) and VanDijken (van Dijken, 2000) . The former showed 17% and 16% while
the latter showed 17.7% and 27.3% failure rates for inlays and fillings respectively and
they both statistically evaluated these differences as insignificant. In the other CCT,
Manhart used three different types of composite to restore cavities with direct fillings and
indirect inlays whereas 93% of the inlays and 87% of the filings have been rated as alpha
or bravo, which is an insignificant difference (Manhart et al., 2000a). However the
allocation has been conducted according to cavity size (fillings for small and inlays for
large) and not randomly which is clearly a selection bias. Mendonca placed 44 fillings and
32 indirect inlays for one year and no failure was appeared (Mendonca et al., 2010). Cetin
in a similar way used three different composites to make three groups of 20 fillings each
and 2 different composites to make two groups of 20 inlays each and no failure was
observed after one year (Cetin and Unlu, 2009). The short recall period of the last two
papers does not allow us to reach to any useful conclusion.
4.4.2.2 Esthetic quality
No obvious deterioration in colour match is reported by Wassell while 30% of the inlays
and 35 % of the direct restorations showed not acceptable marginal discolouration (Wassell
et al., 2000). No details on that particular aspect are given by Spreafico in his RCT
(Spreafico et al., 2005). On the contrary a detailed report was given by Pallessen where
inlays scored better than fillings (Pallesen and Qvist, 2003). Acceptable rates for colour
match and discolouration of the margin were 44% -55% respectively for inlays and 33%-
26% for fillings which is reported as a significant difference only for marginal
discolouration, in favor of fillings. The other four articles found all of the restorations
acceptable with insignificant difference regarding these two measurements.
57
4.4.2.3 Postoperative sensitivity
Spreafico reported sensitivity for one direct restoration and two inlays which equals to
4.5% and 9% respectively at the one month recall (Spreafico et al., 2005). Similarly
Pallessen found 7% and 12% sensitivity (Pallesen and Qvist, 2003) while no sensitivity
was reported by Manhart (Manhart et al., 2000a). Mendonca found 6.66% of the fillings
and 15.62% of the inlays to be sensitive postoperatively and gradually disappear within the
short period of 1 year (Mendonca et al., 2010). They all agree that the differences between
the two materials are not significant.
4.4.3 Clinical performance of composite inlays on premolars versus molars
Table 23 Premolars vs molars
1 RCT Pallessen 2003

2 RCT Huth 2011
3 RCT Manhart 2001
4 CCT Manhart 2000
5 CCT VanDijken 2000
In the RCT by Pallessen 20% of the inlays on molars have failed while only 8% of the
inlays on premolars have failed after 11 years which suggests a significant difference
(P<0.05) (Pallesen and Qvist, 2003). Huth in his RCT used two different composites to
make 155 inlays and found insignificant difference (p=0.576) between failure rates for the
parameter of tooth type after four years (Huth et al., 2011). However in the same study the
findings between the different composites were controversial. There were significant
differences between premolars-molars for the characteristics of tooth integrity and
postoperative symptoms in the Artglass groups while no difference was found in the
Charisma groups. In one of the CCTs it is stated that marginal integrity, anatomic form of
the surface and postoperative symptoms showed better results for premolars than molars
while a significantly higher failure rate observed in molars but unfortunately there is no
differentiation between indirect inlays and direct fillings (Manhart et al., 2000a). The same
author in a different three year study (Manhart et al., 2001) revealed a higher failure rate
for molars compared to premolars but no discrimination has been made between composite
58
and ceramic thus we cannot evaluate his results in the present study. Finally Donly reports
failure rates of 2 out of 18 for premolars and 7 out of 18 for molars but does not explain if
this is significant or not (Donly et al., 1999). Van Dijken in a similar way revealed a higher
failure rate for premolars versus molars 11.9% and 50% respectively (van Dijken, 2000).
4.4.4 Clinical performance of composite inlays on small cavities versus

large
Table 24 Small cavities vs large
1 RCT Huth 2011

2 RCT Wassell 2000
3 RCT Manhart 2001
4 CCT Manhart 2000
In a four year RCT (Huth et al., 2011) no significant difference (p=0.268) was found on
failure rate related to the size of the cavity. On the contrary in the Artglass group small
inlays showed better surface texture and less marginal discolouration while insignificant
difference was reported for Charisma. Wassell in his 5-year study states that all the failures
occurred on large inlays (Wassell et al., 2000). Only for the clinical parameters of marginal
integrity and marginal discolouration Manhart found better results for small cavities
(Manhart et al., 2001) while the same on a different trial mentioned a significant better
marginal integrity for small cavities (Manhart et al., 2000a). However his results on both
studies are biased from the fact that in the former he used only composite inlays in the
small cavities and ceramic in the large while on the latter he used composite fillings and
inlays respectively.
59
5. Discussion
60
5.1 Summary of evidence
Ideally only RCTs should be used in the evaluation of the clinical effectiveness of
composite inlays; however the present search revealed only 9 of them which also do not
assess the same aspect. So it was decided to include the 9 CCTs that qualify to answer the
questions that have formed.
5.1.1 Composite inlays versus ceramic and gold
Regarding their longevity against other materials six articles have given some evidence.
Five of them were comparing composite against ceramic and only one composite against
gold. The survival rate varied from 51% after 10 years to 100% after 3 years. Although
they all agree that composite inlays can perform equally to ceramic inlays, unfortunately
none of them can be used in the present review to form a clear answer whether any
difference occur regarding the longevity, for a different reason each one, as has been well
described in the results section. The comparison of composite and gold is very interesting
as an idea because gold is regarded as the ideal material for the restoration of teeth and can
give us important indication when compared with the characteristics of composite.
Although the author did not find any significant difference between the two materials
regarding longevity (Donly et al., 1999) no randomization has occurred and the recall rate
was only 45% so we cannot really rely on these results.
Aesthetic quality was assessed subjectively. Criteria were chosen to assess two
characteristics, colour match and marginal discolouration, aiming to get an inclusive and
more unbiased “picture” of aesthetics. Three studies were regarded as more appropriate to
be used for this particular aspect and their results are conflicting for the colour match
showing better results for composite inlays (Fasbinder et al., 2005), better results for
ceramic inlays (Kaytan et al., 2005) or no difference between them (Manhart et al., 2001).
It is interesting that the latter found a low agreement between the examiners only on colour
match. The reasons for this divergence are the subjectivity of the issue as well as the
variety of the techniques that being used for the fabrication of the inlays. Regarding the
marginal discolouration there is an agreement between them of insignificant difference
between the two materials. In other words we cannot make any statement on that
hypothesis.
Only two studies could be used for the assessment of the post operative sensitivity
(Manhart et al., 2001, Fasbinder et al., 2005)and they both report no postoperative
61
sensitivity for composites and ceramics at the month recall. Consequently the conclusion
of insignificant difference between them can be accepted. The diversity of the time the
researchers of the rest of the studies chose to check the sensitivity made the extraction of
the available data for the present study harsh.
5.1.2 Composite inlays versus direct composite fillings
Regarding longevity, out of seven trials that were available for comparison between
composites and ceramics, two of them (Mendonca et al., 2010, Cetin and Unlu, 2009) have
a very short period of 12 months of observance from which is rather inappropriate to
extract any results. Rest of the available studies with observation time varied from 3.5 to
11 years and survival rates varied from 87.3% in 11 years to 100% after 3.5 years found
insignificant differences between composite inlays and direct composite fillings. Despite
the fact that evidence comes from quite different designed studies (RCTs and CCTs),
different clinical procedures (direct or semidirect or indirect fabrication) and different
observation periods, longevity between the two methods seems to be similar and the
hypothesis of no difference can be accepted.
Five studies reported on the aesthetic quality subject consisting of the two clinical criteria
of colour match and marginal discolouration. Except of one study which reported better
results on one of the two criteria (marginal discolouration) for fillings (Pallesen and Qvist,
2003), all the others agree that composite give similar aesthetic results when used either
directly or indirectly which seems to support the hypothesis of insignificant difference.
Regarding postoperative sensitivity, four of the studies that compare direct to indirect
composite restorations present results. In spite of the different designs of the studies they
all agree that the difference of postoperative sensitivity is insignificant between the two
methods. Furthermore these studies seem to be quite well conducted thus the hypothesis of
no difference can be accepted.
5.1.3 Composite inlays on premolars versus molars
The third question that has to be answered is whether clinical performance of composite
inlays on premolars is superior to that on molars. Five studies reported on that issue. They
all agree that composite inlays perform significantly better on premolars than on molars.
However the type of the composite being used seems to affect some of the clinical criteria
in some cases, as observed by Huth and co-workers. This could be due to the higher filler
62
content in the Charisma composite (78 wt %) compared to that of the Artglass composite
(69 wt %). Likewise Barone in his case series paper placed 113 inlays in premolars and
molars and found insignificant difference between them for almost all the criteria he
assessed which can be ascribed to the type of the composite that they used (Signum-
Heraeus Kulzer) and consequently to the filler content (75 wt%) (Barone et al., 2008). In a
17 year study of posterior direct composite restorations the results showed a significant
difference for the failure rates between premolars and molars in the mandible but not in the
maxilla (da Rosa Rodolpho et al., 2006). This can be an interesting factor to be assessed in
a future study for indirect composite restorations. On the whole despite the several factors
that affect the final result the majority of the available composites seem to perform better
on premolars than on molars so we can reject the hypothesis of the insignificant difference.
5.1.4 Composite inlays on small cavities versus large
Finally only two studies are appropriate to evaluate the last hypothesis showing opposing
results. Huth found no difference between one-two surface and multi surface while Wassell
reported all the failures on large inlays. The former similarly to the previous issue found
superior grades for some of the criteria he assessed in small cavities. The same conflicting
conclusions have been observed by other researchers. Barone in his case series found no
difference between them after 3 years (Barone et al., 2008) while Leirskar on the contrary
reported a significantly higher success rate for small inlays compared to large (Leirskar et
al., 2003). Dukic in his article compared two types of resin composite for the fabrication of
indirect inlays. He used only large cavities on molars and found all of them clinically
acceptable after 2 years which can be a positive sign for the use of composite for large
inlays however the design of the study was not the appropriate because he did not use a
control group with small cavities and the recall period was only 2 years (Dukic et al.,
2010). To summarize, the available studies cannot answer the stated question.
5.2 Limitations
A systematic review ideally evaluates data extracted from well conducted RCT and
consequently synthesizes the collected information. A comprehensive approach should
include a meta-analysis and a thorough assessment of the bias. In the present review only 9
RCTs were identified whereas 1 could not answer any of the questions. Furthermore not all
of them include information for all the studies. The low quality of the available evidence
63
and the small number of randomised trials as well as the variety of the methodology and
the heterogeneity of the trials prevent us from conducting a meta-analysis which could
confidently give answers regarding the longevity of the composite inlays. For the above
reasons the present study limited to a qualitative analysis. Due to the variety of the used
definitions the extraction of the data was extremely difficult. The decision of the
researchers to modify the existing clinical criteria according to their personal believes was
an extra difficulty factor.
5.3 Quality of the evidence
A proper RCT aims to eliminate all the factors that can affect results and let only the effect
of the intervention to be evaluated. According to author’s belief only one trial is considered
to have low bias (Huth et al., 2011) while only one study provides confidence interval
(Spreafico et al., 2005).
Double blinding is impossible when placing dental restorations. Blinding makes sense for
the outcome evaluation whereas clinicians must not participate at the evaluation procedure
and the examiner accordingly has to be blind. Patient blinding is not always feasible for
example when gold is used although it cannot really affect the outcome. In the present
review blinding is of high importance when assessing the aesthetic quality. However an
experienced dentist usually can spot the difference especially when monochromatic blocks
are used for CAD-CAM restorations. Five studies reported blinding of the outcome (Huth
et al., 2011, Wassell et al., 2000, Manhart et al., 2001, Manhart et al., 2000a, Dukic et al.,
2010) while one reported that the examiner could not visualize the reporting form and
trained recorder was responsible for that (Donly et al., 1999).
An essential part of a correct clinical trial should be the justification of the sample size. In
the present review although all of the studies state the sample size only two CCTs justified
that (Cetin and Unlu, 2009, Mendonca et al., 2010) and any RCT did. When power
calculation is not performed is a certain drawback of the study because a rather small
sample can lead to the incorrect acceptance of insignificance between the assessed
interventions.
Allocation concealment is another essential part of RCT and is defined as “The procedure
for protecting the randomization process so that the treatment to be allocated is not known
before the patient is entered into the study” (Forder et al., 2005). A preferred way is that of
64
sealed envelopes. Only two RCTs performed allocation concealment (Huth et al., 2011,
Fasbinder et al., 2005).
Three of the studies report that they received some kind of support from the manufacturer
(Huth et al., 2011, Wassell et al., 2000, Donly et al., 1999)
The fact of participants dropping out in a clinical trial is inevitable especially when the
sample is large and the observation period long. The reason for this drop outs has to be
stated. In the present review 82.6% of the studies reported the recall rate while 65.2%
reported a recall rate higher than 80%.
Finally 73.9% of the evaluated studies used more than one examiner for the assessment of
the outcome and 65.2% report calibration of them.
5.4 Biases of the review process
A great effort has been made to retrieve all the articles for the purposes of this systematic
review. Potential bias could be the exclusion of non-English articles. English abstracts for
two of them have been identified but the extraction of useful information was impossible
(Khairallah and Hokayem, 2009, Haas et al., 1992). Authors and manufactures have not
been contacted to confirm whether any trial is due to be published. The identification of the
more recent version of the long term study was extremely difficult not only because it was
not always published in the same journal but also because the major author was changed
between the co-authors and sometimes a totally new person was appeared in a study that
has been started by others. This could cause the choice of an earlier version.
5.5 Implications for research
A need for properly conducted RCTs is essential in order the effectiveness of composite
inlays compared to ceramic or gold inlays and direct fillings to be proved as well as to
demonstrate their superiority or inferiority when used for different tooth type and cavity
size. CONSORT guidelines must be followed by authors (Schulz et al., 2010). From the
studies reviewed only one follow the majority of these guidelines (Huth et al., 2011).
Proposals that could be highlighted are:
 Illustration with a flow-diagram of the progress of the trial

 Report of the way of the of randomization
65
 Allocation concealment
 Age and sex distribution of the interventions if feasible
 Stratification of the interventions according to tooth type and cavity size
 Blinding of the outcome
 Split-mouth design
 Justification of the sample size. American Dental Association recommends a
minimum power of 80% using Type I error of 0.05 and Type II error of 0.10 (ADA,
2007).
 Reporting of the drop-outs as well as reasons
 More than one independent, calibrated examiners
 Commonly accepted meaning of failed and unacceptable restorations
In addition, definitions for failed and unacceptable restorations must be standardized and
commonly accepted from the researchers aiming to homogenous results that can later on
extracted and form a meta-analysis. Finally the control must be well tested for long time to
provide adequate power of evidence to the intervention such as gold when longevity of the
composite is tested.
5.6 Implications for practice
Despite the heterogeneity of the evidence composite inlays seem to be a promising

material for the restoration of posterior teeth for all the reasons that have been analyzed.
Equally important is the fact that the majority of the studies report a high acceptance of
them from the patients. However more trials are needed so we can recommend a certain
type of composite and method to be used.
66
6. Conclusion
67
In conclusion after exploring the available trials the answers to the hypotheses stated are:
 There is insufficient evidence to accept or reject the hypothesis of no difference

between composite from one side and ceramic and gold inlays on the other side
regarding longevity and aesthetic quality while is accepted for the issue of
postoperative sensitivity.
 The hypothesis of no difference between composite inlays and direct composite
fillings regarding longevity, aesthetic quality and postoperative sensitivity is
accepted.
 The hypothesis of no difference when restoring premolars and molars with
composite inlays is rejected in favour of premolars
 There is insufficient evidence to accept or reject the hypothesis of no difference
between small and large composite inlays.
In spite of the several limitations, composite inlays can compete ceramic inlays, gold
inlays and composite fillings. Their participation rate in the field of tooth restorations will
grow up the following years.
68
7. Appendices
69
Appendix 1 Clinical procedures
Picture 1 Preparation and impression sequence
70
Picture 2 Sequence of construction
71
Picture 3 Finishing and cementation
72
Appendix 2 Search strategy
1 Dental porcelain OR dental ceramic

2 Composites OR composit$ OR resins OR resin$
3 Gold$
4 Inlays
5 Onlays
6 4 OR 5
7 1 AND 6
8 2 AND 6
9 3 AND 6
10 7 OR 8 OR 9
11 Randomized controlled trial OR RCT
12 Controlled clinical trial OR CCT
13 Case series
14 11 OR 12 OR 13
15 10 AND 14
73
Appendix 3 Characteristics of excluded studies
Name Reason for exclusion

1 (Wassell et al., 1995) Later version of the same
study exists
2 (Manhart et al., 2000b) Later version of the same
study exists
3 (Thordrup et al., 2001) Later version of the same
study exists
4 (Manhart et al., 2010) Later version of the same
study exists
5 (Kreulen et al., 1994) Non-adult study
6 (Scheibenbogen et al., 1997) Later version of the same
study exists
7 (Scheibenbogen-Fuchsbrunner et al., 1999) Later version of the same
study exists
8 (Jung et al., 2004) Mentions only polishing
and finishing methods
9 (Lange and Pfeiffer, 2009) Refers only to direct
composite fillings
10 (Van Meerbeek et al., 1992) Later version of the same
study exists
11 (Leirskar et al., 1999) Later version of the same
study exists
12 (Signore et al., 2007) Cracked teeth were
studied
13 (da Rosa Rodolpho et al., 2006) Refers only to direct
composite fillings
74
Appendix 4 List of the resin composites tested in the included studies
Composition of
Material Type Manufacturer Filler
organic matrix
UDMA,
Polyglass 69 wt%
1. Artglass Heraeus-Kulzer Bis-GMA,
composite Ba-Al-B-Si glass
TEGDMA
Microhybrid Bis-GMA 78 wt%
2. Charisma Heraeus -Kulzer
composite TEGDMA Ba-Al-B-Si glass
Bis-GMA 85 wt%
3. Paradigm Nanocrystaline 3M ESPE
TEGDMA Zr-Si
Bis-GMA 78.5 wt%
4. Brilliant Dentine Hybrid Coltene
TEGDMA Ba-Al-Si glass
Bis-GMA 77 wt%
5. Estilux Microfill Heraeus -Kulzer
TEGDMA Quartz
Urethane
modified 77.5 wt%
6. A.PH Fine hybrid Dentsply caulk
Bis-GMA Ba -Si glass
TEGDMA
Ivoclar Bis-GMA 77 wt%
7. EOS Micro fine
Lichtenstein UDMA Si-O2
UDMA, Bis-
Macrofilled GMA,
8. P-50 3M ESPE Zr-Si
hybrid TEGDMA, Bis-
EMA
UDMA, 81 wt%
9. Tetric Microhybrid Ivoclar Vivadent Bis-GMA, Ba-Ytterbium-Si
TEGDMA glass
Zr-Al-Boro Si
10. Blend-a-lux Hybrid Blendax GmbH Methacrylates
glass
Pertac- hybrid 80 wt%
11. Hybrid 3M ESPE Bis-EMA
unifil Quartz, Si
12. Concept Microfill Ivoclar Vivadent UDMA Si
UDMA, 74 wt%
13. SR-Isosit Microfill Ivoclar Vivadent
aliphatic Si
75
Composition of
Material Type Manufacturer Filler
organic matrix
Dimethacrylates
14. Targis Ceromer Ivoclar Vivadent and 80 wt%
methacrylates
78 wt%
UDMA, Bis- Ba-Al,
15. Tetric ceram TC Packable hybrid Ivoclar Vivadent GMA, fluosilicate glass,
TEGDMA ytterbium
trifluoride
92 wt%
Multifunctional
16. Estenia Nanohybrid Kuraray Ceramic and
methacrylates
glass
DIMA, Bis-
17. Tescera Microhybrid Bisco GMA, 85 wt%
TEGDMA
Microfill- 78 wt%
18. Admira Voco Ormocer
Ormocer Si-O-Si
89 wt%
Bis-GMA, Silicium
19. Grandio Nano-hybrid Voco
TEGDMA dioxide-glass-
ceramic
53 wt%
20. Soli-dex Micro-hybrid Shofu UDMA
Ceramic fillers
UDMA,
75 wt%
21. Signum Micro-hybrid Heraeus Kulzer Bis-GMA,
Si
TEGDMA
76
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COMPOSITE INLAYS: A SYSTEMATIC REVIEW

A dissertation submitted to the University of Manchester for the degree of

1. Introduction and background 11

2. Aims and objectives 26

Word count: 16332

Appendix 1 Clinical procedures 70

WHO World Health Organization

I. The author of this dissertation (including any appendices and or/schedules to

Ceramic inlays have the following advantages:

1.3 Comparison of inlays

Composite inlays versus ceramic and gold

Composite inlays versus direct composite restorations

Final impressions should be accurate so Addition silicone or Polyether is indicated. If the

1.4.6 Placement procedure

Although gold inlays can be bonded normally using glass-ionomer or zinc-phosphate,

1.5 Indications and contraindications of inlays and onlays

While in the following situations an alternative restoration is regarded as a better option.

1.6 Available studies

The Null Hypotheses are:

1. There is no difference in longevity, postoperative sensitivity and aesthetic quality in

Criteria for including studies for this review

Criteria for excluding studies for this review were:

 Non –adults studies

-Ovid Medline 1946 to 2012

-Cochrane Central Register of Controlled trials

-Embase 1980 to 2012

-International Journal of Prosthodontics

-Journal of adhesive dentistry

Figure 1 Flow diagram of study identification

Table 1 Study's quality assessment form-Questions to be answered

1 Are the hypotheses/aims/objectives clearly described?

Table 2 Study's quality assessment form-Answers to the questions I

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

-14%of the fillings and 20%of the

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

-No rates were given for differences

Methods Participants Intervention Outcomes Results

Methods Participants Intervention Outcomes Results

4.4 Effects of interventions

4.4.1 Composite inlays vs ceramic and gold

Table 21 Studies comparing composite vs ceramic and gold

1 RCT Fasbinder et al 2005

4.4.1.1 Longevity analysis

4.4.1.2 Esthetic quality

4.4.1.3 Postoperative sensitivity

4.4.2 Composite inlays versus direct composite fillings

The following articles are available to answer the second hypothesis.

Table 22 Composite inlays vs direct composite fillings

1 RCT Wassell et al 2000

4.4.2.2 Esthetic quality

4.4.3 Clinical performance of composite inlays on premolars versus molars

Table 23 Premolars vs molars

1 RCT Pallessen 2003