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

被引：4

作者：

Chabouis, Helene Fron ^{[1
,2
,3
]}

Prot, Caroline

Fonteneau, Cyrille

Nasr, Karim ^{[4
,5
]}

Chabreron, Olivier ^{[4
,5
]}

Cazier, Stephane

Moussally, Christian

Gaucher, Alexandre

Ben Jaballah, Ines Khabthani ^{[6
]}

Boyer, Renaud ^{[6
]}

Leforestier, Jean-Francois ^{[6
]}

Caumont-Prim, Aurore ^{[6
]}

Chemla, Florence ^{[1
,2
]}

Maman, Louis ^{[1
,2
]}

Nabet, Cathy ^{[4
,5
]}

Attal, Jean-Pierre ^{[1
,2
]}

机构：

[1] Univ Paris 05, Fac Chirurg Dent, Sorbonne Paris Cite, F-92120 Montrouge, France

[2] Hop Charles Foix, AP HP, Serv Odontol, F-94200 Ivry, France

[3] Univ Paris 13, Ecole Doctorale Galillee, Sorbonne Paris Cite, F-93430 Villetaneuse, France

[4] Univ Toulouse 3, Fac Chirurg Dent, F-31062 Toulouse, France

[5] Hotel Dieu St Jacques, Pole Odontol, F-31059 Toulouse, France

[6] Hop Europeen Georges Pompidou, AP HP, INSERM, UMR S872 20, F-75015 Paris, France

来源：

TRIALS | 2013年 / 14卷

关键词：

Dental caries; Inlays; Composite resins; Ceramic; Survival analysis; CAD/CAM; Dental prosthesis; Dental restoration failure; Dental restoration wear; DENTAL RESTORATIVE MATERIALS; SAMPLE-SIZE CALCULATION; CLINICAL-EVALUATION; FATIGUE RESISTANCE; COVARIATE ADJUSTMENT; STRESS-DISTRIBUTION; CONSORT STATEMENT; FLEXURAL STRENGTH; RESIN; PORCELAIN;

D O I：

10.1186/1745-6215-14-278

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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 Federation 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

引用

页数：9

共 62 条

[1]

[Anonymous], 2012, 0703072011594114SERC

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