Ceramic Versus Composite in the Treatment of Posterior Teeth by Inlays or Onlays (CECOIA)

March 12, 2018 updated by: Assistance Publique - Hôpitaux de Paris

Ceramic Versus Composite in the Treatment by Inlays or Onlays of Posterior Teeth Affected by Tooth Substance Loss : a Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

355

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ivry-sur-seine, France, 94200
        • Hôpital Charles Foix (APHP), Service d'odontologie
      • Lyon, France, 69003
        • Dental pratice
      • Paris, France, 75012
        • Dental pratice
      • Paris, France, 75015
        • Dental pratice
      • Paris, France, 75017
        • Dental pratice
      • Toulouse, France, 31059
        • Hôtel Dieu, Service d'odontologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ceramic
Leucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)
Device: ceramic (Empress CAD, Ivoclar Vivadent)
Leucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)
Active Comparator: composite
Nanohybrid composite resin (Lava Ultimate, 3M Espe)
Device: composite (Lava Ultimate, 3M Espe)
Nanohybrid composite resin (Lava Ultimate, 3M Espe)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FDI criteria for dental restorations assessment
Time Frame: at 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration survival analysis
Time Frame: at 2 years
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
wear
Time Frame: at 2 years
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
overall quality of the restoration
Time Frame: at 2 years
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
FDI instrument validity data
Time Frame: at 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France
Hôpital Charles Foix
Hôtel Dieu - Service d'odontologie (Toulouse)
Dental practitionners

Investigators

  • 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (Estimate)

November 12, 2012

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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