Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial
1 Faculté de Chirurgie Dentaire, Université Paris Descartes, Sorbonne Paris Cité, Montrouge 92120, France
2 Service d’Odontologie, Assistance Publique – Hôpitaux de Paris (AP-HP), Hôpital Charles Foix, Ivry-sur-Seine 94200, France
3 Ecole doctorale Galillée, Université Paris 13, Sorbonne Paris Cité, Villetaneuse 93430, France
4 Private Dental Practice, Paris, France
5 Faculté de Chirurgie Dentaire, Université Paul Sabatier, Toulouse 31062, France
6 Pôle Odontologie, Hotel-Dieu Saint-Jacques, Toulouse 31059, France
7 AP-HP, Hôpital Européen Georges-Pompidou (HEGP), Institut National de la Santé et de la Recherche Médicale (INSERM), UMR S872/20, Paris 75015, France
Trials 2013, 14:278 doi:10.1186/1745-6215-14-278Published: 3 September 2013
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.
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.
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.
ClinicalTrials.gov Identifier: NCT01724827