Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial.

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. 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.

Effectiveness of a new one-step self-etch adhesive in the restoration of non-carious cervical lesions: 2-year results of a randomized controlled practice-based study.

OBJECTIVES: The purpose of this practice-based randomized controlled trial was to evaluate the effectiveness of a new one-step self-etch adhesive to restore non-carious cervical lesions following CONSORT guidelines and to test the hypothesis that this adhesive is equally effective with or without beforehand selective etching of enamel. METHODS: Twenty-eight patients each received two restorations randomly assigned to the control or the experimental group. In the control group, the adhesive (Bond Force, Tokuyama) was applied without beforehand enamel phosphoric-acid-etching, whereas the latter was applied first in the experimental group. The restorative composites used for all restorations were Estelite Flow Quick followed by Estelite Sigma (Tokuyama). The clinical effectiveness was assessed at baseline, 6 months, 1 year and 2 years in terms of retention, marginal staining, restoration staining, and post-operative sensitivity. RESULTS: One restoration loss occurred in the control group before the 6-month recall. At the two-year recall, only 2 secondary endpoints showed significant differences between groups: marginal staining at the enamel occurred more often in the control group (29% vs. 5%) (hierarchical linear regression: p=0.011) and 'minor marginal defects' were significantly more frequent in the control group (29% vs. 0%) (hierarchical linear regression: p=0.009). SIGNIFICANCE: Although in a practice setting, the effectiveness of this new adhesive was very good after 2 years of clinical service. More minor defects and restoration staining at the enamel margin were noticed when enamel had not been selectively acid-etched. Selective enamel acid-etching might enhance the adhesive properties of this new one-step self-etch adhesive.