Ceramic Versus Composite in the Treatment of Posterior Teeth by Inlays or Onlays
CECOIA
1 other identifier
interventional
355
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2012
Typical duration for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2012
CompletedStudy Start
First participant enrolled
September 13, 2012
CompletedFirst Posted
Study publicly available on registry
November 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 13, 2018
March 1, 2018
4 years
September 10, 2012
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FDI criteria for dental restorations assessment
2 independent evaluators The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.
at 2 years
Secondary Outcomes (4)
Restoration survival analysis
at 2 years
wear
at 2 years
overall quality of the restoration
at 2 years
FDI instrument validity data
at 2 years
Study Arms (2)
ceramic
ACTIVE COMPARATORLeucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)
composite
ACTIVE COMPARATORNanohybrid composite resin (Lava Ultimate, 3M Espe)
Interventions
Leucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)
Nanohybrid composite resin (Lava Ultimate, 3M Espe)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- subgingival margin after cavity preparation, rubber dam cannot be placed, all tooth cuspids need to be covered by the restoration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Ministry of Health, Francecollaborator
- Hôpital Charles Foixcollaborator
- Hôtel Dieu - Service d'odontologie (Toulouse)collaborator
- Dental practitionnerscollaborator
Study Sites (6)
Hôpital Charles Foix (APHP), Service d'odontologie
Ivry-sur-Seine, 94200, France
Dental pratice
Lyon, 69003, France
Dental pratice
Paris, 75012, France
Dental pratice
Paris, 75015, France
Dental pratice
Paris, 75017, France
Hôtel Dieu, Service d'odontologie
Toulouse, 31059, France
Related Publications (3)
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.
PMID: 18341239RESULTHickel 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.
PMID: 20628774RESULTFron 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.
PMID: 24004961DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
hélène fron chabouis, DDS, MSc
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.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2012
First Posted
November 12, 2012
Study Start
September 13, 2012
Primary Completion
September 1, 2016
Study Completion
March 1, 2017
Last Updated
March 13, 2018
Record last verified: 2018-03