title: Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial.
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 Fédération Dentaire Internationale (FDI) World Dental Federation. Secondary outcomes include this instrument's 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01724827.
authors.affiliation: Faculté de Chirurgie Dentaire, Université Paris Descartes, Sorbonne Paris Cité, Montrouge 92120, France. helene.fron@parisdescartes.fr.
authors.forename: Hélène
authors.initials: H
authors.lastname: Fron Chabouis
authors.forename: Caroline
authors.initials: C
authors.lastname: Prot
authors.forename: Cyrille
authors.initials: C
authors.lastname: Fonteneau
authors.forename: Karim
authors.initials: K
authors.lastname: Nasr
authors.forename: Olivier
authors.initials: O
authors.lastname: Chabreron
authors.forename: Stéphane
authors.initials: S
authors.lastname: Cazier
authors.forename: Christian
authors.initials: C
authors.lastname: Moussally
authors.forename: Alexandre
authors.initials: A
authors.lastname: Gaucher
authors.forename: Inès
authors.initials: I
authors.lastname: Khabthani Ben Jaballah
authors.forename: Renaud
authors.initials: R
authors.lastname: Boyer
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Leforestier
authors.forename: Aurore
authors.initials: A
authors.lastname: Caumont-Prim
authors.forename: Florence
authors.initials: F
authors.lastname: Chemla
authors.forename: Louis
authors.initials: L
authors.lastname: Maman
authors.forename: Cathy
authors.initials: C
authors.lastname: Nabet
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Attal
mesh_terms: D002516:Ceramics / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D003188:Composite Resins / Q000009:adverse effects / Q000627:therapeutic use*; D003731:Dental Caries / Q000175:diagnosis / Q000628:therapy*; D003737:Dental Cavity Preparation; D019232:Dental Restoration Failure; D019554:Dental Restoration Wear; D005602:France; D006801:Humans; D007284:Inlays / Q000009:adverse effects / Q000379:methods*; D016015:Logistic Models; D012107:Research Design; D013499:Surface Properties; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003188:Composite Resins