Received: 13 June 2019 Revised: 8 August 2019 Accepted: 10 September 2019

DOI: 10.1111/jerd.12534

RESEARCH ARTICLE

Two-year performance of CAD/CAM fabricated

resin composite inlay restorations: A randomized
controlled clinical trial

Ayse T. Tunac1 | Esra U. Celik2 | Bilal Yasa2

1
Department of Restorative Dentistry, Faculty
of Dentistry, Yeditepe University, Istanbul,
Turkey
2
Department of Restorative Dentistry, Faculty
of Dentistry, Izmir Katip Celebi University,
Izmir, Turkey
Correspondence
Esra Uzer Celik, Department of Restorative
Dentistry, Faculty of Dentistry, Izmir Katip
Celebi University, Aydinlik Evler Mahallesi,
Cemil Meriç Caddesi, 6780 Sokak. No:48,
35640, Çi
gli, IZMIR
Email: esrauzer@yahoo.com
Abstract
Objective: The aim of this study was to evaluate the 2-year clinical performance of
computer-aided design/computer-aided manufacturing (CAD/CAM) resin composite
inlay restorations in comparison with direct resin composite restorations.
Materials and methods: In 44 patients, 120 class II (mesio-occlusal/disto-occlusal)
cavities were randomly assigned into two groups; CAD/CAM resin composite inlay
group (Lava Ultimate), direct resin composite group (Clearfil Majesty Posterior). Clinical
evaluations were performed after 1 week, 6 months, 1 year, and 2 years according to
the FDI criteria. The data were analyzed using Friedman's ANOVA and Mann-Whitney
U tests (α = .05).
Results: In 41 patients, 114 restorations were evaluated at the second year (recall
rate 93.2%). All restorations were ideal or clinically acceptable. At the first year, consid-
ering all criteria, there were no statistically significant differences between the groups.
However, there was a significant difference in terms of surface luster at second year,
in favor of inlay restorations (P = .015). The marginal staining of resin composites
increased after 2 years (P = .046), but there was no significant difference between the
groups.
Conclusions: Except the surface luster, 2-year clinical performance of CAD/CAM
resin composite inlay restorations was found similar to direct resin composite resto-
rations according to FDI criteria
Clinical Significance: The clinical performance of CAD/CAM resin composite inlays
was acceptable in class II cavities subsequent to 2-year evaluation.

KEYWORDS
CAD/CAM, clinical performance, inlays, randomized clinical trial, resin composite block

1 | I N T RO D UC T I O N defects, including restoration of large cavities. However, partial indirect

Nowadays, direct resin composite posterior restoration is the first
choice of many clinicians in treating carious lesions or other tooth
The manuscript was originally presented as part of CED-IADR/NOF Oral Health Research
Congress in Vienna, Austria on September 20-23, 2017.
restorations (inlay, onlay, and overlay) for excessive posterior tooth
defects have started to replace direct resin composite restorations
after the modern chairside computer-aided design/computer-aided
manufacturing (CAD/CAM) systems were developed.
In recent years, one of the most important advancement in
chairside CAD/CAM systems is the production of resin composite

J Esthet Restor Dent. 2019;1–12. wileyonlinelibrary.com/journal/jerd © 2019 Wiley Periodicals, Inc. 1

2 TUNAC ET AL.
blocks. The first product in this area is Paradigm MZ100, which is an
industrially polymerized version of direct resin composite (Z100).
It contains bisphenol A-glycidyl methacrylate (Bis-GMA), triethylene
glycol dimethacrylate, and 85% (by weight) of zirconia-silica filler;
therefore, its degree of polymerization and mechanical properties are
better than Z100.1
Later, new resin composite blocks containing urethane
dimethacrylate instead of Bis-GMA, which are also produced under
high temperature and high pressure were marketed to increase the
2
degree of polymerization.
In CAD/CAM resin composite blocks developed in recent years,
properties of flexibility and ease of use similar to that of resin compos-
ite are combined with durability and surface finish properties similar to
3
that of ceramics. It was shown that resin composite blocks caused less
wear on the opposing teeth than glass-ceramics and maintained their
luster for a longer time.4 Their nonfusing and composite-like properties
make them easier to mill, polish, and adapt. Resin composite blocks are
produced with better edge properties due to less brittleness. Further-
more, it was shown that these materials produced less blunting on the
drills during milling.5 They can also be repaired using resin composites
with cutback or adding techniques. They can also be repaired using
resin composites with cutback or adding techniques.6 In addition, physi-
cal (color stability, water sorption, and water solubility) and mechanical
(fracture resistant, wear, compressive strength, hardness, and elastic
modulus) properties of resin composite blocks were found better than
that of conventional resin composite due to their higher degree of
polymerization.3,7
Despite the abovementioned advantages, bonding failure in the
cement interface due to high polymerization of resin composite
blocks, discoloration, luster loss over time after restoration, and frac-
tures are the problems that might be considered in their long-term
clinical performance.8 However, there are limited data about the clini-
cal performance of CAD/CAM resin composite partial crown (inlay,
onlay, and overlay) restorations, thus more clinical trials are required
to draw further conclusions about their clinical behavior.8-10
The aim of this study was to evaluate the 2-year clinical perfor-
mance of CAD/CAM resin composite inlay restorations in comparison
with direct resin composite restorations. The null hypothesis was that
there would be no difference between the 2-year clinical performance
of CAD/CAM resin composite inlay restorations and direct resin com-
posite restorations in class II cavities.
2 | MATERIALS AND METHODS
2.1 | Study design
The Ethics Committee at Faculty of Medicine, _Izmir Katip Çelebi Uni-
versity approved the study protocol of this randomized, controlled,
parallel group, and single-center clinical trial (approval no: 2014-16).
The patients were informed about the purpose of the study, treat-
ment stages, dental materials to be used, risks of treatment, and writ-
ten consents were taken before beginning the study.
PASS Sample Size Software (NCSS, LLC, Kaysville, Utah) was used
to calculate the sample size. In order to get the f = 0.25 effect differ-
ence between the groups with 80% power and an alpha error of 5%,
at least 55 restorations per group were needed.
2.2 | Patient selection
A total of 150 patients referred to the Restorative Dentistry Clinic at
the Faculty of Dentistry, _Izmir Katip Çelebi University between May
2014 and November 2014 were examined for eligibility to participate
in the study. One hundred and twenty-six patients who did not meet all
the inclusion criteria were excluded from the study. Forty-four patients
aged between 19 and 45 years (mean age: 28 years) were included in
the study. A signed informed consent form was obtained from all
patients after discussing the purpose of the study, treatment stages,
dental materials to be used, and risks of the treatment. The flowchart
for patient selection and treatment protocol is given in Figure 1.
The inclusion criteria were (a) good general health, (b) older than
18 years of age, (c) able to attend periodical follow-ups, (d) accordance
with rubber dam application, (e) presence of at least two class II (MO or
OD) carious teeth or old restorations, (f) presence of antagonists and
adjacent teeth and occlusal contacts, and (g) signs of vital pulp without
symptoms of pulpitis. The exclusion criteria were (a) allergy to the
restorative materials used in the study; (b) very poor general health and
oral hygiene; (c) pregnant and lactating women; (d) patients with para-
functional habits; (e) symptoms of pulpitis or presence of periapical
lesions; (f) patients undergoing orthodontic treatment; (g) significant
malocclusion (crossbite); (h) severe periodontitis, purulent exudate, den-
tal mobility, advanced periodontal attachment, or bone loss; (i) teeth
supporting removable prosthesis; and (j) nonvital or endodontically
treated teeth.
2.3 | Lesion selection
A total of 120 class II (MO or OD) carious premolars or molars were
included in the study. The carious lesions were moderate through
both pulpal and gingival area at the beginning of the preparation. Cari-
ous teeth were categorized in terms of presence of preoperative sen-
sitivity, lesion depth, tooth type, and presence of liner application and
calcium hydroxide application.
2.4 | Randomization
The second author (E.U.C.) generated random allocation sequence,
enrolled participants, and assigned participants to the study groups.
According to the type of tooth restoration to be applied, patients
included in the study were randomly divided into two groups using
the Microsoft Excel randomization table: (a) direct resin composite
restoration group (60 restorations/44 patients) and (b) CAD/CAM
resin composite inlay group (60 restorations/44 patients). Both treat-
ment alternatives were ranked using numbers, and these numbers
were randomly ranked in accordance with six restorations for each
TUNAC ET AL.
FIGURE 1 Work flow chart
patient in the randomization table. Next, the teeth to be restored in
each patient were ranked from the smallest number to the largest
in accordance with the FDI notation. The treatment alternatives given
in the table were paired with teeth to be restored according to their
rank. At least two and maximum of six teeth of each patient were
included in the study, with an equal number for each group.
2.5 | Restorative procedure
The same experienced dentist (ATT) performed all restorative proce-
dures. Routine professional oral care, including dental surface cleaning
and oral hygiene motivation, were performed. The initial photos of the
teeth were taken using a digital camera (Nikon D7100, Tokyo, Japan)
with the help of an intraoral photo mirror. The periapical tissues of the
teeth to be included in the study were initially checked using panoramic
radiographs. The shades of the teeth were determined using VITA clas-
sical color scale.
2.5.1 | Direct resin composite restoration group
Local anesthesia (Maxicaine, Vem _Ilaç, Istanbul, Turkey) was applied
if necessary. Carious tissue and old restorations were removed using
diamond and tungsten carbide burs (ISO 806314001544016, ISO
806314110524014 and ISO 500314001006016, MEDIN, Inc, Nové
Město na Moravě, Czech Republic). The caries affected dentin tissue at
the base of the cavity was left. After the carious tissue was removed
cavity borders were finished according to the basic cavity preparation
principals. Unsupported enamel edges were removed. All cavity edges
were terminated on the enamel and all internal surfaces were termi-
nated in dentin. The enamel margins were not beveled. Only cavities
which were prepared as mesio-occlusal or disto-occlusal were included
3
in the study. The teeth were discarded from the study if the isthmus
width was more than 2/3 of the distance between the tubercule tips,
or if the walls were thinner than 2 mm before the preparation or thin-
ner than 1.5 mm after the preparation. However, any cavity preparation
was not removed from the study due to this reason.
Before restoration of the teeth, rubber dam isolation was
applied. Calcium hydroxide (Dycal, Dentsply, Milford, Delaware)
was applied to the areas where the remaining dentin thickness was
less than 0.5 mm. The teeth were discarded from the study if the
pulp was exposed; however, such a situation did not occur. Resin-
modified glass ionomer liner (Vitrebond Plus, 3M ESPE, St. Paul,
Minnesota) was applied to the cavities treated with calcium
hydroxide.
The cavities were restored using a partial matrix system (Palodent
Matrix System/Standard Kit, Dentsply, Milford, Delaware), wooden
wedges, three-step etch-and-rinse adhesive system (OptiBond FL,
Kerr, California), and a nanohybrid resin composite (Clearfil Majesty
Posterior, Kuraray, Tokyo, Japan). The details and application proce-
dures of tested materials are given in Table 1.
All tested materials were used according to the manufacturers'
instructions and light-cured with a light-emitting diode (LED) curing
unit (VALO Cordless, Ultradent, South Jordan, Utah) set at a standard
power of 1000 mW/cm2.
After removing the rubber dam, occlusion control, finishing, and
polishing was done with ultrafine diamond burs (ISO 806314167504012
and ISO 806314257504016, MEDIN) polishing rubbers (Jazz Polishers,
SS White Dental, Lakewood, New Jersey), and polishing discs (Sof-Lex,
3M ESPE). Diamond polishing paste (Intensiv UniglossPaste, Intensiv SA,
Montagnola, Switzerland) was applied with a bristle brush. The surfaces
under the approximal contact point were finished with interproximal
polishing strips (Coltène, Altstätten, Switzerland).
4 TUNAC ET AL.
TABLE 1 Restorative materials used in the study
Material Manufacturer
Clearfil Majesty Posterior, Kuraray, Okayama, Japan
Resin Composite
Lava Ultimate, Resin 3M ESPE, St. Paul,
Composite CAD/CAM Block Minnesota
Optibond FL Etch&rinse Kerr, Orange
Adesive System
Vitrebond Plus Resin Modified 3M ESPE, St. Paul,
Glass Ionomer Liner Minnesota
RelyX Ultimate Dual Cure 3M ESPE, St. Paul,
Resin Cement Minnesota
Abbreviations: BIS-GMA, bisphenol A-glycidyl methacrylate; CAD/CAM, computer-aided design/computer-aided manufacturing; HEMA, hydroxyethyl
methacrylate; TEGDMA, triethyleneglycol dimethacrylate.
2.5.2 | CAD/CAM resin composite inlay group
All cavity preparations were performed with fine inlay burs (Expert-
Set 4562.314/ST, Komet Dental, Lemgo, Germany) according to inlay
cavity principles. The walls facing each other were prepared 5 to 6
divergent with 80 μm diamond burs and were finished with 25 μm
diamond burs.9 All internal angles were rounded and all edges were
terminated in the enamel. The pulpal floor was prepared at a depth of
11
at least 1.5 mm. The teeth were discarded if isthmus width was
more than 2/3 of the distance between the tubercule tips, or if the
walls were thinner than 2 mm before the preparation or thinner than
1.5 mm after the preparation. However, no cavity preparation was
removed from the study due to this reason. The caries affected dentin
tissue at the cavity floor was left. Following the rubber dam isolation,
calcium hydroxide was applied to the areas where the remaining den-
tin thickness was less than 0.5 mm. The teeth were discarded from
the study if the pulp was exposed but such a situation did not occur.
To eliminate irregular areas in the cavities, resin-modified glass
ionomer liner was applied as a blockout material.
CAD/CAM inlays were produced using the CEREC system
(Dentsply Sirona, York, Pennsylvania). The optical imaging of the cav-
ity was obtained by a digital camera (Omnicam, Dentsply Sirona). The
design of the restoration was performed using CEREC SW 4.3
(Dentsply Sirona). Relevant blocks (Lava Ultimate, 3M ESPE) were
selected to produce actual restoration by milling in the CAD/CAM
system (CEREC MC-XL, Dentsply Sirona, York, Pennsylvania).
Ingredients Lot number
BIS-GMA, TEGDMA, hydrophobic aromatic A2: AR0002
dimethacrylate, silanized glass ceramic, alumina A3: 0127AA
micro fillers, silica particles, camphorquinone
Silica nanomers, zirconia nanomers, silanizing agent, A2 HT: N525442
resin matrix A2 HT: N538336
A2 HT: N525442
A2 HT: N628830
A2 LT: N554521
A3 HT: N557733
A3 HT: N557733
A3 HT: N557733
A3 LT: N548041
A2 LT: N554521
A3 LT: N548041
A3 LT: N548041
Primer: Alcyl dimethacrylate resin ethyl alcohol, water Primer: 4633039
Bond: HEMA, hydroxypropane diyl bis methacrylate, Bond: 4689426
alkaline fluorosilicate
Liquid: Resin modified polyalkenoic acid, HEMA, water, N480593
and initiators
Powder: HEMA, BIS-GMA, water, initiators, and
radioopaque fluoro aluminosilicate
Glass powder, TEGDMA, silanized silica, oxyde glass 525320
chemicals, sodium persulfate, tert-butyl
peroxy-3,5,5-trimetil hexanoate
Inlay restorations were polished with discs (Sof-Lex, 3M ESPE),
polishing rubbers (Jazz Polishers, SS White Dental, Lakewood, New
Jersey), and polishing paste (Intensiv UniglossPaste, Intensiv SA).
Cementation of the restoration was carried out with the rubber
dam isolation. The cementation surface was sandblasted with the
30 μm aluminum oxide at 2 bar pressure (CoJet System, 3M ESPE) for
5 seconds and air-dried following cleaning with alcohol. Three-step
etch-and-rinse adhesive system (OptiBond FL, Kerr) and a dual-cure
adhesive cement (RelyX Ultimate, 3M ESPE) were applied to the
cavity and restoration surfaces according to the manufacturer's
instructions. After placement, the residues were cleaned with an
applicator and floss, and the restoration margins were covered
with glycerin gel. The stabilization of the restoration was achieved
once the setting reaction of the cement was completed. The
cement was cured with an LED device for 20 seconds from each
surface for a minimum of 60 seconds. After 6 minutes of mixing
time, the polymerization allowed to complete for 6 minutes, and
then the rubber dam was removed to check for occlusal contacts.
The surfaces were polished with discs (Sof-Lex, 3M ESPE) and
polishing paste (Intensiv UniglossPaste, Intensiv SA).
2.6 | Evaluation of restorations
The restorations were examined at baseline and subsequently at
6-month, 1-year, and 2-year follow-ups. The clinical evaluation was
 TUNAC ET AL.

TABLE 2 FDI criteria for esthetic properties

Properties 1. Surface luster 2. Surface staining 3. Marginal staining 4. Color stability and translucency 5. Anatomic form
Evaluation method Visually Visually Visually Visually Visually
1. Clinically excellent/very 1.1. Luster comparable to 2.1. No surface staining 3.1. No marginal staining 4.1. Good color match. No 5.1. Form is ideal
good enamel difference in shade and
translucency
2. Clinically good (after 1.2. Slight dull, not noticeable 2.2. Minor staining, easily 3.2. Slight marginal staining but 4.2. Minor deviations 5.2. Form is only affected
polishing very good) from speaking distance removable not penetrating
3. Clinically sufficient/ 1.3. Dull surface but acceptable 2.3. Moderate surface staining, 3.3. Slight and penetrating 4.3. Clear deviation but acceptable. 5.3. Form differs but is not
satisfactory (minor if covered with film of saliva also present on other teeth, marginal staining Does not affect esthetics esthetically displeasing
shortcomings with no not esthetically unacceptable
adverse effects but not
adjustable without damage
to the tooth)
4. Clinically unsatisfactory 1.4. Rough surface, cannot be 2.4. Surface staining present on 5.4. Marginal staining through 4.4. (Localized) clinically 5.4. Form is affected and
(but reparable) masked by saliva film, simple the restoration and is the dentin unsatisfactory but can be unacceptable esthetically
polishing is not sufficient. unacceptable; major corrected by repair intervention (correction)
Further intervention necessary intervention necessary for necessary
improvement
5. Satisfactory poor 1.5. Quite rough, unacceptable 2.5. Severe staining and/or 5.5. Unacceptable marginal 4.5. Unacceptable. 5.5. Form is completely
(replacement necessary) plaque retentive surface subsurface staining staining through the dentin Replacement necessary unsatisfactory and/or lost repair
(generalized or localized); not not feasible/reasonable,
accessible for intervention replacement needed
5

TABLE 3 FDI criteria for functional properties
Properties
Evaluation Method
1. Clinically excellent/very
good
2. Clinically good (after
polishing very good)
3. Clinically sufficient/
satisfactory (minor
shortcomings with no
adverse effects but not
adjustable without damage
to the tooth)
4. Clinically unsatisfactory (but
reparable)
5. Satisfactory poor
(replacement necessary)
6. Fractures and retention
Visually and tactilely (with probe) Visually and tactilely (with probe) Visually
6.1. Restoration retained, no
fractures/cracks
6.2. Small hairline crack
6.3. Two or more larger hairline
cracks and/or chipping (not
affecting the marginal integrity
or proximal contact)
6.4. Chipping fractures which
damage marginal quality or
proximal contacts; bulk
fractures with or without
partial loss (less than half of
the restoration)
6.5. (Partial or complete) loss of
restoration
7. Marginal adaptation
7.1. Harmonious outline, no
gaps, no discoloration
7.2. Small marginal gap
removable by polishing
(<150 μm)
7.3. Gap (<250 μm) not
removable
7.4. Notable gap (>250 μm) or
dentin/base exposed
7.5. Restoration is lost
8. Occlusal contour and wear
8.1. Physiological wear
equivalent to enamel (80%-
120% of corresponding
enamel)
8.2. Normal wear with only slight 9.2. Slightly too strong but no
difference to enamel (50%-
80% or 120%-150% of
corresponding enamel)
8.3. Differing wear rate to
enamel but within biological
variation (<50% or 150%-
300% of corresponding
enamel)
8.4. Wear considerably exceeds
normal enamel wear; or
occlusal contact points are lost
(restoration >300% of enamel
wear or antagonist >300%)
8.5. Wear is excessive
(restoration or antagonist
>500% of corresponding
enamel)
9. Proximal contour and contact
Visually and tactilely (with floss
and metal matris bands)
9.1. Normal contact point (Floss
or 25 μm metal band can be
inserted but not 50 μm)
disadvantage
9.3. Slightly too weak, no
indication of damage to tooth,
gingiva or periodontal
structures (50 μm metal band
can pass easily but not
100 μm)
9.4. Too weak (100 μm metal
band can pass) and possible
damage (food impaction)
Repair possible
9.5. Too weak and/or clear
damage (food impaction)
and/or pain/gingivitis Requires
replacement
6
10. Patient's view
Question-answer
10.1. Entirely satisfied
10.2. Satisfied
10.3. Minor criticism of
esthetics, chewing. No
adverse clinical effects
10.4. Desire for improvement
(reshaping of anatomic form
or refurbishing, etc)
10.5. Completely dissatisfied
and/or adverse effects
including pain
TUNAC ET AL.
 TUNAC ET AL.

TABLE 4 FDI criteria for biological properties

11. Postoperative
hypersensitivity and 12. Secondary caries,
Properties vitality erosion and abrasion 13. Tooth integrity 14. Periodontal response 15. Adjacent mucosa 16. Oral and general health
Evaluation method Air pressure application Visually and tactilely Visually and tactilely Visually and tactilely (with Visually Question-answer visually
at 3 cm distance and (with probe) (with probe) periodontal probe)
cold (dry ice) test
1. Clinically excellent/ 11.1. No hypersensitivity, 12.1. No secondary 13.1. Complete integrity 14.1. No plaque, no 15.1. Healthy mucosa adjacent 16.1. No oral or general
very good normal vitality caries inflammation no pockets to restoration symptoms
2. Clinically good (after 11.2. Low 12.2. Very small and 13.2. Small marginal 14.2. Little plaque, no 15.2. Healthy after minor 16.2. Minor transient
correction very hypersensitivity for a localized enamel split or crack inflammation no pockets removal of mechanical symptoms of short duration
good) limited period time, demineralization/ (<150 μm) not irritations (sharp edges etc) (of known or unknown
normal vitality erosion/abrasion/ probable origin) local or generalized.
abfraction No
operative treatment
required
3. Clinically sufficient/ 11.3.1. Premature/ 12.3. Larger areas of 13.3. Enamel split or 14.3. Acceptable plaque 15.3. Alteration of mucosa but 16.3. Transient symptoms,
satisfactory (minor slightly more intense demineralization/ crack (<250 μm) no accumulation/gingival no suspicion of causal local and/or general
shortcomings with 11.3.2. Delayed/weak erosion/abrasion/ adverse effects bleeding/pocket formation relationship with restorative
no adverse effects sensitivity; no abfraction but only material
but not adjustable subjective complaints, preventive measures
without damage to no treatment needed necessary (dentin not
the tooth) exposed)
4. Clinically 11.4.1. Premature/very 12.4.1. Caries with 13.4. Major enamel split 14.4. Not acceptable plaque 15.4. Suspected mild allergic, 16.4. Persisting local or
unsatisfactory (but intense cavitation or crack (gap >250 μm) accumulation/gingival lichenoid, or toxicological general symptoms of oral
repair for 11.4.2. Extremely 12.4.2. Erosion in dentin dentin or base bleeding/pocket formation reaction contact stomatitis or lichen
prophylactic reasons) delayed/weak with 12.4.3. Abrasion/ exposed, probe depth >1 mm compared to planus or allergic reactions
subjective complaints abfraction in dentin penetrates reference tooth (or remitting) Intervention
11.4.3. Negative localized and necessary but no
sensitivity. accessible and can be replacement
Intervention necessary repaired
but no replacement
5. Satisfactory poor 11.5. Very intense, acute 12.5. Deep secondary 13.5. Cusp or tooth 14.5. Severe/acute gingivitis or 15.5. Suspected severe allergic, 16.5. Acute/severe local
(replacement pulpitis, or nonvital caries or exposed fracture periodontitis lichenoid, or toxicological and/or general symptoms
necessary) endodontic treatment dentin that is not reaction
is necessary and accessible for repair of
restoration has to be restoration
replaced
7
8 TUNAC ET AL.

performed by two calibrated observers other than the clinician who TABLE 5 Evaluation criteria and lesion numbers
performed clinical applications using FDI criteria (Tables 2–4). Restora-
Inlays/direct
tions were evaluated according to the three main criteria: (a) esthetics Evaluation method resin composite
(surface luster, surface discoloration, marginal discoloration, color match, Preoperative Anamnesis and 3 seconds air
translucency, and anatomical form), (b) functional (material fracture or sensitivity pressure application at
retention, marginal adaptation, occlusal contour and wear, proximal con- 3 cm distance
tour and contact, and patient's vision), and (c) biological (postoperative No sensitivity 45/40
sensitivity and vitality, caries formation, erosion or abrasion, tooth integ- Provoked 15/20
rity, periodontal response, adjacent mucosa, and oral and general health). Cavity depth Visual examination after
Restorations were scored using a scale of 1 to 5 as: (a) clinically preparation

excellent/very good, (b) clinically good (after correction very good), Shallow Dentin penetration ≤1 mm 3/6
(c) clinically sufficient/satisfactory (minor shortcomings with no Normal Dentin penetration >1 mm, 27/32
adverse effects but not adjustable without damage to the tooth), Remaining dentin
thickness >2 mm
(d) clinically unsatisfactory (repair for prophylactic reasons),
Deep Remaining dentin thickness 30/22
(e) satisfactory poor (replacement necessary). A score of 1 to 3 repre-
≤2 mm
sented a clinically accepted restoration and 4 or 5 represented fail-
Teeth Upper-lower/
ure. In case of a disagreement, a consensus between examiners was upper-lower
achieved after discussion. Prior to the study, calibration was per-
Premolar 19-12/19-15
formed on e-calib between the two observers.
Molar 17-12/13-13
Liner application
2.7 | Statistical analysis Applied 60/15
Not applied 0/45
The data were statistically analyzed with SPSS Statistics software, ver-
sion 22 (IBM Corporation, Armonk, New York). Cavity depth, preoper- Calcium hydroxide
application
ative sensitivity, calcium hydroxide, and liner application values of
Applied 20/15
restorative materials were compared with the Mann-Whitney U test.
Not applied 40/45
Friedman ANOVA test was used to analyze the differences in data
throughout the different evaluation periods for all criteria. Differences
between two restorative materials for each criterion were analyzed found between the groups at the baseline, 6-month, and 1-year
using Mann-Whitney U test in each evaluation period. In all tests, the follow-ups in any of the criteria. However, there was a significant dif-
probability level for statistical significance was α = 0.05. ference between the groups in terms of surface luster during the
2-year recall, in favor of inlay restorations (P = .015).
According to Friedman's ANOVA test, there was a statistically sig-
3 | RESULTS
nificant decrease in surface luster of resin composite restorations
between 6-month/1-year (P = .046) and 6-month/2-year (P = .005)
Out of 44 patients with a total of 120 restorations (65 premolar and
follow-ups. The resin composite group had four restorations with a
55 molar) included in the study, 32 patients had two restorations,
score of 2 in the first year and eight restorations with a score of 2 in
11 patients had four restorations, and 2 patients had six restorations.
the second year. Furthermore, the marginal staining of resin compos-
There was no statistically significant difference between the
ite restorations significantly increased after 2 years (P = .046).
groups in terms of preoperative sensitivity, cavity depth, and calcium
hydroxide application, which were considered to affect the success of
the treatment and clinical performance (Table 5). Liner application was 4 | DISCUSSION
observed to be higher in CAD/CAM resin composite group (P < .05).
All patients returned for 6-month and 1-year follow-ups, while Direct resin composite restorations are widely preferred to restore
three patients could not be followed up in the second year. The patient posterior teeth. Because they are easy to apply, low cost, made in one
recall rate was 93.2% and 114 restorations could be evaluated in session and require minimally invasive preparations.12,13 On the other
41 patients in the second year. The results from clinical evaluations and hand, varying degrees of deterioration in the esthetic properties (sur-
statistical comparisons are given in Table 6. The tests of both inter- face luster, surface discoloration, marginal discoloration, color match,
examiner and intraexaminer agreement resulted in Cohen's kappa translucency, and anatomical form) are commonly seen in direct com-
statistics of 0.80, 0.85, and 0.83. posite restorations within time.14-16 Increased demand for long-lasting
The retention rate was 100% for both study groups in the 2-year esthetic restorations have led to many improvements in the produc-
follow-up. All restorations were ideal or clinically acceptable in the tion techniques of posterior restorations such as CAD/CAM systems.
second year (Figures 2–4). No statistically significant difference was This technique simplifies the production of indirect restorations and
 TUNAC ET AL.

TABLE 6 Score distribution of the restorations according to the FDI criteria

Resin composite restorations Resin composite inlays

Baseline Six-month One-year Two-year Success rate Baseline Six-month One-year Two-year Success rate
(1/2/3/4/5) (1/2/3/4/5) (1/2/3/4/5) (1/2/3/4/5) % (1/2/3/4/5) (1/2/3/4/5) (1/2/3/4/5) (1/2/3/4/5) %
Anatomic Surface luster 60/0/0/0/0 60/0/0/0/0 56/4/0/0/0 49/8/0/0/0 100 60/0/0/0/0 60/0/0/0/0 59/1/0/0/0 56/1/0/0/0 100
Surface staining 60/0/0/0/0 59/1/0/0/0 58/2/0/0/0 54/3/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 56/1/0/0/0 100
Marginal staining 60/0/0/0/0 59/1/0/0/0 57/3/0/0/0 53/4/0/0/0 100 60/0/0/0/0 59/1/0/0/0 59/1/0/0/0 55/2/0/0/0 100
Color stability and translucency 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 54/3/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 56/1/0/0/0 100
Anatomic form 60/0/0/0/0 60/0/0/0/0 59/1/0/0/0 56/1/0/0/0 100 60/0/0/0/0 60/0/0/0/0 59/1/0/0/0 56/1/0/0/0 100
Functional Fractures and retention 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100
Marginal adaptation 60/0/0/0/0 59/1/0/0/0 59/1/0/0/0 55/2/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 54/3/0/0/0 100
Occlusal contour and wear 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 56/1/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100
Proximal contour and contact 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100
Patient's opinion 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100
Biological Postop sensitivity and vitality 60/0/0/0/0 60/0/0/0/0 59/1/0/0/0 57/0/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100
Secondary caries erosion and abrasion 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100
Tooth integrity 60/0/0/0/0 60/0/0/0/0 59/1/0/0/0 57/0/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100
Periodontal response 60/0/0/0/0 60/0/0/0/0 59/1/0/0/0 56/1/0/0/0 100 60/0/0/0/0 60/0/0/0/0 59/1/0/0/0 56/1/0/0/0 100
Adjacent mucosa 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100
Oral and general health 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100 60/0/0/0/0 60/0/0/0/0 60/0/0/0/0 57/0/0/0/0 100
9
10 TUNAC ET AL.

F I G U R E 2 A computer-aided design/computer-aided manufacturing resin composite inlay restoration: A, The previous old amalgam
restoration on the maxillary left first molar; B, The scanned image of cavity preparation; C, The design of the restoration; D, Baseline; E, One-year
follow-up (score 1 for all criteria); F, Two-year follow-up (score 1 for all criteria)

F I G U R E 3 A computer-aided design/computer-aided manufacturing resin composite inlay restoration: A, A carious lesion on the distal
approximal surface of maxillary left first premolar; B, The scanned image of cavity preparation; C, The design of the restoration; D, Baseline; E,
One-year follow-up (score 1 for all criteria); F, The restoration was scored “2” for surface luster at the 2-year follow-up
TUNAC ET AL.
F I G U R E 4 A direct resin composite restoration: A, A carious
lesion on the occlusal and mesial approximal surface of mandibulary
right second molar; B, Baseline; C, One-year follow-up (score 1 for all
criteria); D, The restoration was scored “2” for surface luster at the
2-year follow-up
make it possible to use advanced materials.17-19 The CAD/CAM resin
composite blocks have better mechanical and physical properties
compared to conventionally polymerized resin composites because
they are industrially polymerized in high and standardized tempera-
ture and pressure. Thus, better clinical performance was expected
with CAD/CAM resin composite blocks in terms of functional and
esthetic properties compared to direct resin composites.19-21 How-
ever, these superiorities should also be proven with clinical trials
before it is accepted as an advantageous situation.
The null hypothesis tested in this study was rejected. CAD/CAM
resin composite restorations exhibited better surface luster compared
with the direct composite restorations during the 2-year follow-up.
However, the problems are acceptable in direct composite restora-
tions; alternatively, all restorations in each group produced successful
clinical performance after 2 years.
At present, there are a few studies on the clinical performance of
CAD/CAM resin composite partial crowns, even none of them included
its comparison with the posterior direct composite restorations. 8-10
In
these studies, CAD/CAM resin composite partial crown restorations
revealed acceptable clinical success similar to the findings of the pre-
8
sent study. Zimmermann et al reported a clinical success rate of 85.7%
for CAD/CAM resin composite partial crowns after 2 years. Fasbinder
et al9 showed that Paradigm performed similar to the porcelain
CAD/CAM inlays after 10 years of clinical service with a clinical success
rate of 95%. Furthermore, Paradigm had a significantly better fracture
resistance and color match at 10 years compared to the porcelain
10
inlays. A success rate of 97% was reported by Lu et al with a
11
polymer-infiltrated ceramic network material for the onlay restorations
of endodontically treated posterior teeth.
Even though there is no report on the comparison of CAD/CAM
resin composite partial crowns and direct posterior resin composite
restorations, there are many clinical studies comparing direct and
indirect resin composite restorations that found no differences
between the clinical success of these restorations.22-24 In accor-
dance with our results, Dukic et al25 studied the 3-year clinical per-
formance of indirect and direct resin composite restorations and
found a 100% success rate for both materials Cetin et al26 found
that the 5-year success rates of direct resin composite inlay resto-
rations and direct resin composite restorations were 97.5% and
98.4%, respectively.
In the present study, direct composite restorations exhibited worst
surface luster than CAD/CAM resin composite inlays at the end of the
second year. Cetin and Unlu27 reported better surface properties for
indirect restorations and related the result to the higher wear resistance
of the material. In the present study, surface luster reduction was
observed in direct resin composite restorations after 6 months. This
may be due to the fact that resin composite restorations are more
prone to surface wear and can only be polished intraorally.
The marginal staining increased in direct composite restorations
after 2 years compared to their scores at baseline. Marginal staining
is caused by the accumulation of discoloring agents through gaps
between restoration and cavity wall. The gaps are frequently cau-
sed by polymerization shrinkage, polymerization stresses, and
mechanical stresses of chewing forces in direct composites.14 In
other studies evaluating the clinical performance of posterior direct
composites, small marginal defects and superficial marginal discol-
oration were commonly observed even in the earlier stages of long-
term clinical trials.14-16
In this study, no reduction was observed in any criteria throughout
the whole evaluation periods in CAD/CAM group. Nevertheless, clini-
cally acceptable deterioration in anatomic form and marginal adaptation
in CAD/CAM resin composite partial crowns after 2 years was shown
by Zimmermann et al8 The variation between the findings of different
studies may be attributed to the extention of the restorations.10 In gen-
eral, more clinical problems are observed in larger restorations.8,10
5 | C O N CL U S I O N S
The 2-year clinical performance of CAD/CAM resin composite inlay
restorations was found similar with direct resin composite restora-
tions according to FDI criteria, except for the surface luster. However,
long-term clinical studies are required to estimate the long-term
mechanical strength and esthetic durability of restorative materials in
the dynamic oral environment.
ACKNOWLEDG MENTS
This study was supported by BAP Commission of Izmir Katip Celebi
University (2014-T1-TSBP-02).
12
ORCID
Esra U. Celik https://orcid.org/0000-0002-2620-0436
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How to cite this article: Tunac AT, Celik EU, Yasa B. Two-
year performance of CAD/CAM fabricated resin composite
inlay restorations: A randomized controlled clinical trial.
J Esthet Restor Dent. 2019;1–12. https://doi.org/10.1111/jerd.
12534