Clinical trial NCT01724827: Ceramic Versus Composite in the Treatment of Posterior Teeth by Inlays or Onlays
Official title: Ceramic Versus Composite in the Treatment by Inlays or Onlays of Posterior Teeth Affected by Tooth Substance Loss : a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Caries
Inlays
Keywords: Dental caries
inlays
composite resins
IPS-Empress ceramic
bicuspid
FDI dental restorations evaluation criteria
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Hôpital Charles Foix
name: Hôtel Dieu - Service d'odontologie (Toulouse)
name: Dental practitionners
First posted: 2012-11-12
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this trial is to determine which material, between ceramic and composite, is best to manufacture dental inlays and onlays in the treatment of moderate dental substance losses, generally due to dental caries. Restorations will be done using direct Computer Assisted Design and Manufacturing (CAD-CAM). Another aim of this study is to determine which factors influence the success of these restorations.

Detailed description: WHO estimates dental caries prevalence to be over 90% adults worldwide. When tooth substance loss due to the decayed tissue is small, a filling is done by the dentist directly. When the substance loss is important, dentists often treat it with a crown, which presents the disadvantage of further mutilating the tooth. An intermediate technique consists in manufacturing an inlay or an onlay: these restorations become more and more common since they are a minimally invasive solution in such cases. Inlays and onlays can be made of metal, ceramic or composite. Patients tend to refuse metallic restorations, so that dentists generally have to choose between composite and ceramic. Composite wears whereas ceramics fracture. Published in vitro studies provide possible answers to which material is most effective but very few clinical studies have been conducted to confirm them. Material\\'s choice for inlay manufacturing is thus more country-based than evidence-based (Most french dentists choose composite while US dentists prefer ceramics for example). The main objective of this trial is to compare the clinical performance of ceramic and composite inlays/onlays. Other objectives include looking for the prognostic factors of these restorations and validating the criteria proposed by the World Dental Federation (FDI) to evaluate dental restorations.

Eligibility criteria: Inclusion criteria :

* patient aged 18-70,who tolerates restorative procedures and presents a moderate-sized dental caries or restoration (that needs to be replaced) necessitating an inlay/onlay restoration.

Exclusion criteria :

* allergy to one of the materials employed, bruxism, severe or acute periodontal or carious disease, poor oral hygiene
* Tooth presents a mobility \> II, a periodontal socket \> 3mm or supports a removable partial denture

Randomization criterium :

* tooth necessitates an inlay-onlay restoration after caries or former restoration removal

Exclusion from randomization criteria :

* subgingival margin after cavity preparation, rubber dam cannot be placed, all tooth cuspids need to be covered by the restoration.

Primary outcomes:
measure: FDI criteria for dental restorations assessment
timeFrame: at 2 years
Secondary outcomes:
measure: Restoration survival analysis
timeFrame: at 2 years
measure: wear
timeFrame: at 2 years
measure: overall quality of the restoration
timeFrame: at 2 years
measure: FDI instrument validity data
timeFrame: at 2 years
Other outcomes:
Locations:
city: Ivry-sur-seine
country: France
facility: Hôpital Charles Foix (APHP), Service d'odontologie
city: Lyon
country: France
facility: Dental pratice
city: Paris
country: France
facility: Dental pratice
city: Paris
country: France
facility: Dental pratice
city: Paris
country: France
facility: Dental pratice
city: Toulouse
country: France
facility: Hôtel Dieu, Service d'odontologie
Study officials:
affiliation: APHP, Hôpital Charles Foix, Service d'odontologie, Ivry-sur-Seine, France ; Faculté de chirurgie dentaire, Service de biomatériaux (URB2i EA4462), Université Paris Descartes, Sorbonne Paris Cité, Montrouge, France.
name: hélène fron chabouis, DDS, MSc
role: STUDY_DIRECTOR
References:
citation: Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47.
citation: Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
citation: Fron Chabouis H, Prot C, Fonteneau C, Nasr K, Chabreron O, Cazier S, Moussally C, Gaucher A, Khabthani Ben Jaballah I, Boyer R, Leforestier JF, Caumont-Prim A, Chemla F, Maman L, Nabet C, Attal JP. Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial. Trials. 2013 Sep 3;14:278. doi: 10.1186/1745-6215-14-278.