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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-13

Study Completion Date

2017-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dental Caries Inlays

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ceramic

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

Group Type ACTIVE_COMPARATOR

ceramic (Empress CAD, Ivoclar Vivadent)

Intervention Type DEVICE

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

composite

Nanohybrid composite resin (Lava Ultimate, 3M Espe)

Group Type ACTIVE_COMPARATOR

composite (Lava Ultimate, 3M Espe)

Intervention Type DEVICE

Nanohybrid composite resin (Lava Ultimate, 3M Espe)

Interventions

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ceramic (Empress CAD, Ivoclar Vivadent)

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

Intervention Type DEVICE

composite (Lava Ultimate, 3M Espe)

Nanohybrid composite resin (Lava Ultimate, 3M Espe)

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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hélène fron chabouis, DDS, MSc

Role: STUDY_DIRECTOR

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.