Efficacy of composite versus ceramic inlays and

onlays: study protocol for the CECOIA randomized

controlled trial
Fron Chabouis et al.
Fron Chabouis et al. Trials 2013, 14:278
http://www.trialsjournal.com/content/14/1/278

Fron Chabouis et al. Trials 2013, 14:278

http://www.trialsjournal.com/content/14/1/278

STUDY PROTOCOL

TRIALS
Open Access

Efficacy of composite versus ceramic inlays and

onlays: study protocol for the CECOIA randomized
controlled trial
Hlne Fron Chabouis1,2,3*, Caroline Prot4, Cyrille Fonteneau4, Karim Nasr4,5,6, Olivier Chabreron4,5,6, Stphane Cazier4,
Christian Moussally4, Alexandre Gaucher4, Ins Khabthani Ben Jaballah7, Renaud Boyer7, Jean-Franois Leforestier7,
Aurore Caumont-Prim7, Florence Chemla1,2, Louis Maman1,2, Cathy Nabet5,6 and Jean-Pierre Attal1,2

Abstract
Background: Dental caries is a common disease and affects many adults worldwide. Inlay or onlay restoration is
widely used to treat the resulting tooth substance loss. Two esthetic materials can be used to manufacture an
inlay/onlay restoration of the tooth: ceramic or composite. Here, we present the protocol of a multicenter
randomized controlled trial (RCT) comparing the clinical efficacy of both materials for tooth restoration. Other
objectives are analysis of overall quality, wear, restoration survival and prognosis.
Methods: The CEramic and COmposite Inlays Assessment (CECOIA) trial is an open-label, parallel-group,
multicenter RCT involving two hospitals and five private practices. In all, 400 patients will be included. Inclusion
criteria are adults who need an inlay/onlay restoration for one tooth (that can be isolated with use of a dental
dam and has at least one intact cusp), can tolerate restorative procedures and do not have severe bruxism,
periodontal or carious disease or poor oral hygiene. The decayed tissue will be evicted, the cavity will be
prepared for receiving an inlay/onlay and the patient will be randomized by use of a centralized web-based
interface to receive: 1) a ceramic or 2) composite inlay or onlay. Treatment allocation will be balanced (1:1).
The inlay/onlay will be adhesively luted. Follow-up will be for 2 years and may be extended; two independent
examiners will perform the evaluations. The primary outcome measure will be the score obtained with use of
the consensus instrument of the Fdration Dentaire Internationale (FDI) World Dental Federation. Secondary
outcomes include this instruments items, inlay/onlay wear, overall quality and survival of the inlay/onlay. Data
will be analyzed by a statistician blinded to treatments and an adjusted ordinal logistic regression model will be
used to compare the efficacy of both materials.
Discussion: For clinicians, the CECOIA trial results may help with evidence-based recommendations concerning
the choice of materials for inlay/onlay restoration. For patients, the results may lead to improvement in long-term
restoration. For researchers, the results may provide ideas for further research concerning inlay/onlay materials
and prognosis.
This trial is funded by a grant from the French Ministry of Health.
Trial registration: ClinicalTrials.gov Identifier: NCT01724827
Keywords: Dental caries, Inlays, Composite resins, Ceramic, Survival analysis, CAD/CAM, Dental prosthesis, Dental
restoration failure, Dental restoration wear

* Correspondence: [email protected]
1
Facult de Chirurgie Dentaire, Universit Paris Descartes, Sorbonne Paris
Cit, Montrouge 92120, France
2
Service dOdontologie, Assistance Publique Hpitaux de Paris (AP-HP), Hpital
Charles Foix, Ivry-sur-Seine 94200, France
Full list of author information is available at the end of the article
2013 Fron Chabouis et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the
Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly cited.

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Background
The World Health Organization (WHO) estimates the
prevalence of dental caries is over 90% among adults
worldwide [1,2]. When the loss of tooth substance due
to decay is minor, the dentist fills the tooth cavity. With
substantial tooth substance loss, the dentist often treats
the tooth with a crown, which presents the problem of
further destroying the tooth. Large amalgam or build-up
amalgam restorations are also used in such cases in
many countries; however, amalgam is being abandoned
for environmental reasons, especially in Europe [3]. An
intermediate technique consists of manufacturing an
inlay or onlay for the tooth and this type of restoration
has become common because it is a minimally invasive
solution (further information on inlays and onlays is
available at http://cecoia.fr) [4]. Inlays and onlays can be
made of metal alloy, ceramic or composite materials;
however, patients tend to refuse metallic restorations
for esthetic and financial reasons [5], and thus dentists
generally have to choose between composite and ceramic
materials.
The chemical composition differs between ceramic
and composite inlays and onlays, and explains most of
their clinical properties. Ceramic inlays and onlays (ceramics) are mainly composed of glass, with some crystals
added to increase strength [6,7]. Composite inlays and
onlays (composites) are made of a resinous matrix and
fillers of different types [8]. Like glass, ceramics are thus
brittle [9] and more prone to fracture than composites
[10,11]. However, ceramics are harder than composites:
they are thus more wear-resistant but can induce more
wear than usual with the opposing tooths surface [12].
Furthermore, adhesive cement interfaces are made of
composite material, therefore the wear of the interface
and restoration material should be closer for composites,
with less marginal gaps [13,14]. Another disadvantage
of composites is their resinous matrix. An incompletely
polymerized matrix can result in monomers than are
released into the mouth, which presents some toxicity,
whereas ceramics are extremely biocompatible [15-19].
A disadvantage of ceramics is that manufacturing is
time-consuming; composites are easier to polish and
perhaps less costly.
Some factors may influence the clinical performance
of ceramic and composite inlays and onlays differently.
Ceramics are resistant to compressive forces but susceptible to shear stresses. Increased compressive forces can
be expected with onlays, thus the inlay or onlay factor
may influence the performance of the materials differently
[10,11]. Bicuspids usually offer more favourable conditions
for inlays and onlays than molars: cavities are usually
smaller, the effect of masticatory forces and stresses at the
adhesive interface are less intense, and access for dental
treatment is easier [20]. Tooth type (bicuspid or molar)

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may thus influence the performance of composite and

ceramic inlays and onlays [21]. Tooth vitality may also
differently influence the clinical performance of both
materials; some in vitro studies and simulations have
suggested that composites could perform better than
ceramics for non-vital teeth [22,23]. Finally, the operator
(dentist) who performs the restoration is a key variable
[20,24]; practitioners equipped with the computer-assisted
design/computer-assisted manufacturing (CAD/CAM)
system (CEREC, Sirona Dental Systems, Long Island City,
NY, USA) used in this trial manufacture mostly ceramic
inlays and onlays, and may require a slight learning curve
to manufacture composite inlays or onlays.
A systematic search of the literature conducted for this
report identified only two randomized clinical studies
that have compared ceramic and composite inlays and
onlays (see Research in context section) [25-27]. These
studies were small in size (43 and 37 patients) and
presented some risk of bias. The results from both trials
suggested no clear evidence of a difference between
ceramic and composite inlays or onlays. Since then,
materials have improved, composites (especially as CAD/
CAM blocks) have become much safer and consensus
outcomes for evaluating dental restorations have been
developed [28].
Research in context
Systematic search of the literature

Following the Cochrane methodology, we searched MEDLINE and Embase for reports of prospective randomized
controlled studies comparing at least one composite and
one ceramic material for inlay or onlay manufacturing,
with a minimum follow-up of 6 months, and without any
date or language restriction up to 11 October 2012.
Studies identified through the systematic search

In vitro: 91 studies
Only one ceramic or one composite (no control or
luting agent/base material randomized): 20 studies
(27 reports)
Ceramic versus ceramic: three studies
Composite versus composite: two studies
Ceramic versus composite (non-randomized or
retrospective study): five studies (eight reports)
Ceramic versus composite (prospective randomized
study): two studies (four reports)
Interpretation

Only two randomized studies were identified, which compared ceramic and composite materials for inlay or onlay
manufacturing. In 2005, a study compared 80 VITA Mark
II (ceramic; Vita Zahnfabrik, Bad Sckingen, Germany)
and Paradigm (composite; 3M Espe, St Paul, MN, USA)
CAD/CAM inlays in 43 adults after 3 years with use of

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the US Public Health Service (USPHS) modified criteria

[29]. The composite inlays performed better for only two
items: color match and restoration fracture [25]. In 2006,
a study compared 58 CEREC, Vita Dur N (two ceramics;
Vita Zahnfabrik), Brilliant DI (Coltene/Whaledent AG,
Altsttten, Switzerland) and Estilux (two composites;
Heraeus Kulzer GmbH, Hanau, Germany) inlays in 37
patients after 10 years with use of the California Dental
Association criteria [30]: survival was similar for all
inlays when repairs were not considered failures (75 to
80%) and was better for CEREC ceramic inlays than
other inlays when repairs were considered failures (80%
versus 51 to 67%) [26]. Data on the material to use for
manufacturing inlays or onlays are thus controversial
and a RCT is needed.
The main objective of the CEramic and COmposite Inlays Assessment (CECOIA) randomized controlled trial
(RCT) is to compare the clinical efficacy of composite and
ceramic inlays or onlays for treating moderate substance
loss of posterior teeth in adults according to recent
consensus outcomes. Secondary objectives include the
overall quality, wear and survival of inlays and onlays
made of both materials, and prognostic factors of restoration failure, including patient-related items.

Methods
This trial is a multicenter, randomized, open-label superiority trial with two balanced parallel arms. The trial
received approval from the French ethics committee for
the protection of persons (Comit de Protection des
Personnes (CPP), Ile de France XI, trial number 12029)
in May 2012.

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the eligible tooth. Other required inlays or onlays will

be manufactured by the dentist with the usual material
(leucite-reinforced glass-ceramic). In case of pulpal exposure, the operator will decide whether a direct pulp capping
(with calcium hydroxide) or an endodontic treatment is
necessary, randomize the patient after this treatment
has been conducted and fill the corresponding fields in
the adverse events section of the case report form (CRF).
Eligibility criteria for operators (dentists)

Operators will be eligible for inclusion if they have at

least 3 years of clinical experience and at least 1 year of
experience with chairside CAD/CAM, agree with the
intervention protocol, and have no preference for either
composite or ceramic to manufacture inlays and onlays.
Eligibility criteria for evaluators

Evaluators of restorations during follow-up will be two

dentists different from the operators.
Setting

Patients will be included and treated in seven centers

in France: the dental care departments of two hospitals
(Hpital Charles Foix, Ivry-sur-Seine and Hotel-Dieu
Saint-Jacques, Toulouse) and five private practices (four in
Paris and one in Lyon). Follow-up data will be collected in
these seven centers. Any patient with the eligible criteria
visiting one of the included centers will be asked to participate in the study. The consent form can be consulted
at http://cecoia.fr: extra section.
Interventions

Participants and setting

Eligibility criteria for patients

Patients are eligible to participate in the trial if they are

adults aged 18 to 70 years, can tolerate restorative
procedures and have a posterior moderate-sized dental
caries or aged restoration necessitating an inlay or
onlay. Exclusion criteria are allergy to one of the materials
used, bruxism, severe or acute periodontal or carious
disease (greater than or equal to four primary or secondary restorations due to caries in the preceding year)
and poor oral hygiene; the tooth to be treated should
not need endodontic treatment or retreatment, show
mobility >1 mm or a periodontal socket >3 mm or support
a removable partial denture.
Patients with a tooth showing a subgingival margin after
cavity preparation, that cannot be isolated with use of a
rubber dam, or that has cusps that all need to be covered
by the restoration are not eligible.
Only one tooth per patient is eligible. If a patient needs
more than one inlay/onlay restoration, the tooth with
expected cervical limits that are the most coronal, is

Patients will be allocated to receive a leucite-reinforced

glass-ceramic or a composite CAD/CAM inlay or onlay.
Among the ceramics currently used, we chose a pressed
glass-ceramic because fired feldspathic ceramics have
shown higher fracture rates [31], and we chose leucitereinforced glass-ceramic (IPS Empress CAD, Ivoclar
Vivadent, Schaan, Liechtenstein) over lithium disilicatereinforced glass-ceramic because the latter has been
frequently evaluated clinically. Among available composites, we chose a recently developed material (Lava
Ultimate, 3 M ESPE, St Paul, MN, USA), which we
considered promising after laboratory testing.
Although the purpose was not to study CAD/CAM
but to compare composite and ceramic as inlay or onlay
materials, we decided to use CAD/CAM for the inlays
or onlays in this trial to standardize the manufacturing
(as compared with the necessary variability with a dental
technician). This technology also simplifies the protocol
and conduct of the trial, since some CAD/CAM systems
allow for manufacturing inlays or onlays chairside during
a single appointment.

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For cavity preparation, the operator will choose the

color for both evaluated materials (A1/A2/A3). With the
patient under local anesthetic, if needed, the cavity will
be prepared (for dental caries or former restoration
eviction) using a burs sequence (Komet, Rock Hill, SC,
USA) specifically designed for the CECOIA trial. Adjacent
teeth will be protected (FenderWedge, Directa, Upplands
Vsby, Sweden) [32,33]. The following thicknesses will
be respected: 2 mm wide and 1.5 mm deep for isthmuses,
and 1.2 mm wide for approximal boxes, the approximal
overhang not exceeding the box width. Cusps will be
covered if the width of the isthmus is greater than half
of the intercusp buccolingual distance, the wall is 2
mm thick before preparation, the wall is 1 mm thick
after preparation, the width of the isthmus is close to
half the intercusp buccolingual distance and one or
more cracks are observed or the preparation is mesioocclusal-distal or with horizontal forces [34-36]. A base
can be applied (dental dam; OptiBond XTR and Premise
Flowable, Kerr, Orange, CA, USA).
Computer-assisted design/computer-assisted manufacturing
(CAD/CAM)

After powder spraying (CEREC Optispray, Sirona Dental

Systems), the operator will scan the preparation with use
of a digital camera and design the restoration by use of
CEREC software (Sirona Dental Systems). If eligibility
criteria are still satisfied, the operator will then randomize
the tooth to a treatment (randomization procedure
described below), insert the corresponding block inside
the milling machine and press the button for the restoration to be milled. The operator will then check the
approximal contacts of the resulting restoration, correct
them if need be, remove the machining lug and weigh the
restoration.
Surface treatment and polishing of ceramic inlays or onlays

The operator can glaze (IPS Object Fix Putty, glazing

paste and stains, Ivoclar Vivadent) or polish the inlay or
onlay using the polishers provided in the sequence and
diamond paste (OptraFine, Ivoclar Vivadent). The intaglio surface will then be treated with hydrofluoric acid
(Porcelain Etchant gel, Bisico, Schaumburg, IL, USA) for
60 seconds, rinsed, dried, silanated (Monobond Plus,
Ivoclar Vivadent) and left to dry for at least 3 minutes
before sealing.
Surface treatment and polishing of composite inlays
or onlays

The operator will polish the inlay or onlay using the

polishers provided in the sequence, and may modify
the color (Kolor Plus, Kerr) of pits and fissures. The
intaglio surface will be sandblasted with 50 m alumina,

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rinsed, dried, silanated (Monobond Plus) and left to dry

for at least 3 minutes before sealing.
Inlay or onlay adhesive luting and finishing

A dental dam (DermaDam medium, Bisico) will be used.

The tooth surface will be cleaned by air abrasion (RO
NDOflex, KaVo, Biberach, Germany). Enamel will be
etched with orthophosphoric acid (37.5%) for 15 seconds,
rinsed thoroughly and dried gently [37]. Adhesive (Optibond XTR) will be applied by gently brushing the
tooth surface for 15 seconds, followed by a 3-second
air spray and light polymerization of the adhesive for
20 seconds. The inlay will be handled with use of a
stick (Stik-N-Place, Directa); adhesive cement (NX3
yellow, Kerr) will be applied generously on the intaglio
surface of the restoration. The inlay or onlay will be
positioned and maintained. It may be light polymerized
for 1 or 2 seconds. Excess cement will be carefully removed
by use of dental floss and a curette. Glycerine gel will be
applied on the limits of the restoration, followed by light
polymerization of the cement for 40 seconds per face. The
occlusion will then be adjusted, and the corrected surfaces
and cement interface will be polished.
Outcomes
Primary outcome

The primary outcome, clinical efficacy of materials, will be

measured by use of the Fdration Dentaire Internationale
(FDI) World Dental Federation instrument for assessing
dental restorations, described in 2007 [28] and updated in
2010 [38]. This instrument contains three dimensions (18
items): biological (six items), functional (seven items) and
esthetic (five items). Each item is assessed by clinical
examination on a 5-point Likert scale (1 corresponding to
a perfect restoration and 5 corresponding to a restoration
that needs to be replaced), and collected in the CRF. All
items but one are assessed by the dentist; the remaining
item is patient-reported satisfaction. The primary outcome
is the worst score for all items (ranging from 1 to 5) at
2-year follow-up (the best material will be the one with
the lowest score).
Operators and evaluators, who will assign scores, will
be trained in the FDI criteria by means of the e-calib
web-based software (http://zep01793.dent.med.uni-muen
chen.de/moodle/) and group training sessions. They will
use the evaluation kit specifically designed for evaluating the FDI criteria (EX-KIT 150/250, Deppeler, Rolle,
Switzerland).
Secondary outcomes

Secondary outcomes will include each item of the FDI

instrument, patient-relevant outcomes, quantified wear
analysis (through silicone impressions) and overall quality

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of the restoration (as assessed by dentists). Survival may

be evaluated if the follow-up is extended.
Follow-up evaluations

The restorations will be evaluated after 1 week by the

operator, and after 1 and 2 years by two independent
evaluators (Table 1). Follow-up is planned and funded for
2 years; it may be extended to 5 years (as recommended
for indirect dental restorations by the FDI) if the grant
can be extended.
Data collection

Investigators will use a CRF (available at http://cecoia.fr)

to record all items required for outcomes analysis. The
CRF comprises two adverse events forms (one concerning
general health and one concerning inlay/onlay-related
events). Patient data will be anonymous because patients
will be identified by their inclusion number (the first letter
of their first and last name and date of birth only will
be registered in the CRF). A clinical research assistant
(RB) will visit each center every 20 inclusions to monitor
the collection of data (by checking that no CRF field is
incomplete) and assess the quality (by comparing the
data in the medical record, entered through the online
inclusion and randomization software RandoWeb (Assistance Publique Hpitaux de Paris (AP-HP), Paris; http://
randoweb.aphp.fr), written in the CRF). The data will be
entered twice in the database by operators and checked
by a data manager (more information about data management procedures is available at http://cecoia.fr: extra
and protocole initial sections). Some elements in the
CRF allow for checking for operators adherence to the
protocol.

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Sample size

We estimated the required sample size for the primary

outcome (score between 1 and 5, 5 corresponding to the
worst score) for the 18 items for each patient. Since the
resulting score is an ordinal variable, we used Zhaos
formula, which is based on the expected distribution of
responses in each of the five possible ratings [39]. To
the best of our knowledge, no data on the FDI score
are available. Consequently, we derived assumptions
from previous studies [25,26,40-47] that involved the
USPHS score [29], with dimensions close to that of the
FDI score [28]. Thus, we derived assumptions regarding
the expected distribution of ratings for the ceramic and
composite groups for each of the three dimensions
(biological, functional and esthetic). As a proxy for the
FDI score, the worst score across the three dimensions,
we estimated the three sample sizes required to guarantee a power of 80%, with a type I error rate of 1.7%
(Bonferroni adjustment for three dimensions), to detect
expected differences in distribution of ratings between
the ceramic and composite groups for each dimension.
We considered the largest required sample size, which
was found for the biological dimension. Consequently,
with an overall type I error risk of 5%, a sample size of
211 patients would guarantee 80% power to detect a
difference between an expected 3% for scores 3, 4 or 5
in one group and an expected 7% in the other group.
Finally, since several centers and several operators will
participate, we expected that outcomes from a same
center and a same operator will be more similar than
those from different centers or different operators. We
took this intracenter/operator correlation of data and
applied an inflation factor [48,49], which resulted in an

Table 1 Schedule of enrollment, interventions and assessments

Study period
Enrollment Allocation Postallocation Closeout
Time point

- 1yr

1 wk

1 yr

2 yr

Enrollment:
Eligibility screen

Informed consent

Allocation

Interventions:
(composite or ceramic inlay/onlay)

Assessments:
Baseline variables
(inlay/onlay, premolar/molar, vital/non vital, operator, sex, date of birth, restoration volume etc.)

Outcome variables
FDI criteria
Radiograph
Impression

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estimated sample size of 358 patients. We will include

400 patients to account for patients lost to follow-up,
although we will try to avoid missing data on outcome
measures (in particular, by compensating each patient
with 100 euros (100) after 2 years) [50].
The enrolment capacity was estimated to be 75 patients
per year for each hospital and 50 patients per year for each
private practice. A 1-year period was planned for including
these 400 patients.

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Therefore, the trial will be open-label. Randomization

was thus planned as late as possible to insure that the
tooth cavity would be prepared in the same way for both
groups and to limit bias due to the absence of blinding.
Interventions were standardized as much as possible (in
particular, similar adhesive luting procedure) to enhance
similarity. The statistician will be blinded to the treatment arms during data analysis.
Statistical methods

Randomization sequence generation

From a literature review, we considered four major factors

that could differentially influence the performance of
ceramic and composite inlays and onlays (inlay/onlay,
premolar/molar, vital/non-vital tooth and operator),
and that we should aim for balanced distribution of
these factors between the two groups. Consequently,
treatment allocation will involve minimization with a
30% random element. Minimization was preferred over
stratified randomization from the results of extensive
simulations showing minimization with the lowest predictability and imbalance between treatment groups,
considering the trials sample size and these four factors
(details about these simulations and the results are
available at http://cecoia.fr) [51,52].
Allocation concealment

The operator will obtain each randomization allocation

through a centralized secured web-based interface that
runs the minimization algorithm (RandoWeb). The sequence is thus concealed until the intervention is assigned.
Implementation

The minimization algorithm was added to the RandoWeb

software. It was programmed by an independent statistician. Investigators will enroll participants (inclusion numbers are obtained by use of RandoWeb).

The data will be analyzed by an independent statistician.

The unit of analysis will be the patient (only one tooth
treated per patient). The demographic and clinical characteristics of patients and treated teeth will be described
for both treatment arms with the usual statistics: mean
and SD or median and interquartile ranges for quantitative variables, number of subjects, and percentages for
qualitative variables [53]. The analyses will be performed
according to the intention-to-treat principle [54].
Primary outcome analysis

The main analysis will compare the final values of the FDI
score (worst score over the three dimensions) between the
ceramic and composite groups. The main analysis will be
adjusted on the following pre-specified variables: inlay/
onlay, premolar/molar, vital/non-vital tooth and operator
[53,55]. An ordinal logistic regression model will be used.
The operator variable will be modeled as a random effect.
The main analysis will take into account missing outcome
data by multiple imputation, with the assumption that
data are missing at random. We will report the unadjusted
analysis as well; that is, the contingency table showing the
distribution of FDI scores in the ceramic and composite
groups. The distribution of FDI scores will be compared
by Fishers exact test. All P values will be two-tailed, with
significance level 0.05.
Secondary outcomes analysis

Blinding/masking

Operators cannot be blinded to the randomization because the intervention differs between both arms (in
particular, surface treatments of the upper and intaglio
surfaces of the restoration). Moreover, a dentist can
easily recognize each material, so neither operators nor
evaluators can be blinded. Patients are not blinded,
firstly because a few patients had been asked if they
would prefer one material to the other and most did
not have any preference; secondly because it would
complicate the clinical session because the block is
inscripted with the name of the material and the intervention differs between both arms; and thirdly because
another dentist could tell them if their restoration is
made of composite or ceramic.

The same analyses will be used to compare both treatments by each of the three dimensions (with an risk of
1.7% for each dimension). Secondary analyses will also
involve FDI items, quantified analysis of wear (by silicone
impressions) and analysis of the overall quality of the restoration (assessed by dentists).
Subgroup analyses

We will perform subgroup analyses [56] of the following

variables: inlay/onlay, premolar/molar, vital/non-vital tooth,
inlay/onlay volume, canine or group lateral guidance
and occlusal tapping before luting of the inlay/onlay. If
interaction tests are performed for six subgroups independent of each other and each at a significance level
of 5% (two-sided), the risk of finding at least one false-

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positive statistically significant interaction (that is, due

to sampling fluctuations) is 26% (= 1 (1 0.05)6).

Discussion
For clinicians, the CECOIA trial will help provide evidence-based recommendations concerning the choice of
material for inlay/onlay restorations. However, because the
manufacturing technique explains part of the inlay/onlays
properties, the results concerning ceramic and composite
inlay/onlay manufacturing will be applicable only for CAD/
CAM inlays/onlays and not for traditionally manufactured
inlays/onlays. In particular, CAD/CAM composite blocks
contain few monomers, which could limit biological failures
as compared with traditionally manufactured composites;
ceramic blocks present better mechanical properties
initially but milling may induce fissures. However, the
materials still have a similar composition and this trial
may give an idea of their clinical performance.
For patients who receive CAD/CAM inlays/onlays,
this trial may lead to an improvement in the longevity of
the restorations. For researchers, it may provide ideas for
further research concerning the efficacy and prognosis
of inlays and onlays.
Trial status
The trial was submitted for registration at ClinicalTrials.
gov on 10 September 2012. Patient recruitment started
on 14 September 2012. This protocol was submitted for
publication on 20 November 2012. General information
about the trial (such as the original protocol submitted
to the ethics committee) can be obtained on the trials
website (http://cecoia.fr). We will share the data obtained.
Abbreviations
ANSM: Agence Nationale de Scurit du Mdicament et des Produits de
Sant; AP-HP: Assistance Publique Hpitaux de Paris; CAD/CAM:
Computer-assisted design/computer-assisted manufacturing;
CECOIA: CEramic and COmposite Inlays Assessment; CONSORT: Consolidated
Standards of Reporting Trials; CPP: Comit de Protection des Personnes;
CRF: Case report form; DRCD: Dpartement de la Recherche Clinique et du
Dveloppement; FDI: Fdration Dentaire Internationale; HEGP: Hpital
Europen Georges-Pompidou; ICH: International Conference on
Harmonisation; PHRC: Programme Hospitalier de Recherche Clinique;
RCT: Randomized controlled trial; USPHS: US Public Health Service;
SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials;
WHO: World Health Organization.
Competing interests
The authors declare that they have no competing interests.
Authors contributions
HFC conceived the study and its design, participated in its coordination,
and drafted the protocol in accordance with the International Conference
on Harmonisation (ICH) E9 guidelines [57], the Consolidated Standards of
Reporting Trials (CONSORT) 2010 statement [58], the CONSORT statement
extension for nonpharmacologic treatments [59], the CONSORT statement
extension for abstracts [60] and the Standard Protocol Items:
Recommendations for Interventional Trials (SPIRIT) 2013 statement [61]. IBJ,
RB and ACP participated in the methods development and design of the
study. JPA supervised the design and coordination of the study, and the
drafting of the protocol. FC, LM and CN provided leadership for the

Page 7 of 9

hospitals to participate in the study. SC, CF, AG, CM, CP, KN and OC
provided clinical advice. All authors read and approved the
final manuscript.
Authors information
HFC teaches dental material courses in Paris and specializes in clinical
research; and is the trials scientific coordinator. IBJ is the clinical trial
coordinator, RB is the clinical research assistant, JFL is the informatics
engineer and data manager (head of the Data Monitoring Committee, which
is independent from the sponsor and competing interests), and ACP is the
statistician. IBJ, RB, JFL and ACP work as methodologists at the clinical
research unit, Hpital Europen Georges-Pompidou (HEGP), Paris. SC, CF, AG,
CM, CP, KN and OC are private dental practitioners specializing in direct
CAD/CAM. KN and OC work part-time at Hotel-Dieu Saint-Jacques, Toulouse.
CN specializes in epidemiology and clinical research; and leads the Toulouse
team. LM and FC manage the department of dentistry at the Hpital Charles
Foix, Ivry-sur-Seine; the coordinating center. JPA teaches dental material
courses in Paris and works as a private practitioner; and is the trials main
investigator. HFC, KN, OC, CP, CF, SC, CM and AG are the operators.
Acknowledgements
The CECOIA trial is funded by a grant of 236,700 euros (236,700) from the
France Ministry of Health through the national programme for clinical
research in hospitals (Programme Hospitalier de Recherche Clinique (PHRC)).
The sponsor is the AP-HP. The protocol was registered as number P1101129CECOIA by the promoter (AP-HP and Dpartement de la Recherche Clinique
et du Dveloppement (DRCD)). This report is based on the protocol version
1.0 (issued 14 March 2012; version 3.0 was issued 4 February 2013, with only
minor changes concerning centers and their addresses). The CECOIA trial
was authorized by the board for evaluating medical devices of the national
agency for the security of drugs and health products in France (Agence
Nationale de Scurit du Mdicamentet des Produits de Sant (ANSM)) and
is registered as 2012-A00093-40 (IDRCB/Eudract). A 2-year report will be
submitted to the sponsor (in French) and then published (in English,
authorship eligibility guidelines can be consulted in the French protocol
available at http://cecoia.fr).
We thank Moufida Dabbech and Karine Goude from the DRCD for
promoting the CECOIA project. We thank the team from the HEGP hospital
(Gilles Chatellier, Pierre Durieux, and Florence Gillaizeau) for advising and
encouraging the authors. We thank the Paris Descartes University dean
(Grard Levy) for encouraging and facilitating this project.
We thank all the firms who will provide the materials to be used in this
study: Ivoclar Vivadent, 3 M ESPE, Komet, Kerr, Sirona Dental Systems, Bisico
and Directa. These firms did not have any authority in the study design and
will not have any on the decision to submit the report for publication
(except if they buy the whole trial from AP-HP).
Author details
1
Facult de Chirurgie Dentaire, Universit Paris Descartes, Sorbonne Paris
Cit, Montrouge 92120, France. 2Service dOdontologie, Assistance Publique
Hpitaux de Paris (AP-HP), Hpital Charles Foix, Ivry-sur-Seine 94200, France.
3
Ecole doctorale Galille, Universit Paris 13, Sorbonne Paris Cit, Villetaneuse
93430, France. 4Private Dental Practice, Paris, France. 5Facult de Chirurgie
Dentaire, Universit Paul Sabatier, Toulouse 31062, France. 6Ple Odontologie,
Hotel-Dieu Saint-Jacques, Toulouse 31059, France. 7AP-HP, Hpital Europen
Georges-Pompidou (HEGP), Institut National de la Sant et de la Recherche
Mdicale (INSERM), UMR S872/20, Paris 75015, France.
Received: 20 November 2012 Accepted: 13 August 2013
Published: 3 September 2013
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Cite this article as: Fron Chabouis et al.: Efficacy of composite versus
ceramic inlays and onlays: study protocol for the CECOIA randomized
controlled trial. Trials 2013 14:278.

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