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Completed

NCT Number: NCT01724827

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

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.

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Key information

Conditions

Dental Caries Aortic Valve Disease Bicuspid Aortic Valve Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Inlays Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Charles Foix (APHP), Service d'odontologie, Ivry-sur-Seine, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ceramic (Empress CAD, Ivoclar Vivadent)

Device

Leucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)

composite (Lava Ultimate, 3M Espe)

Device

Nanohybrid composite resin (Lava Ultimate, 3M Espe)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CECOIA

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Nov 12, 2012
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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