Ceramic Versus Composite in the Treatment of Posterior Teeth by Inlays or Onlays (CECOIA)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Caries Inlays |
Device: ceramic (Empress CAD, Ivoclar Vivadent) Device: composite (Lava Ultimate, 3M Espe) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- FDI criteria for dental restorations assessment [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]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.
- Restoration survival analysis [ Time Frame: at 2 years ] [ Designated as safety issue: No ]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.
- wear [ Time Frame: at 2 years ] [ Designated as safety issue: No ]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.
- overall quality of the restoration [ Time Frame: at 2 years ] [ Designated as safety issue: No ]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.
- FDI instrument validity data [ Time Frame: at 2 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 400 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: jean-pierre attal, DDS, PhD | 01 58 07 67 82 ext 33 | jean-pierre.attal@parisdescartes.fr |
| France | |
| Hôpital Charles Foix (APHP), Service d'odontologie | Recruiting |
| Ivry-sur-seine, France, 94200 | |
| Contact: Louis Maman, DDS, PhD 01 49 59 48 00 ext 33 louis.maman@cfx.aphp.fr | |
| Contact: florence chemla, DDS, PhD florence.chemla@cfx.aphp.fr | |
| Dental pratice | Recruiting |
| Lyon, France, 69003 | |
| Contact: caroline prot, DDS 04 78 76 08 45 ext 33 cprot@hotmail.fr | |
| Dental pratice | Recruiting |
| Paris, France, 75015 | |
| Contact: christian moussally, DDS 01 47 34 25 78 ext 33 docteur.moussally@wanadoo.fr | |
| Dental pratice | Recruiting |
| Paris, France, 75017 | |
| Contact: Cyril fonteneau, DDS 01 40 67 91 49 ext 33 cyril.fonteneau@free.fr | |
| Dental pratice | Recruiting |
| Paris, France, 75012 | |
| Contact: stephane cazier, DDS 01 43 43 49 10 ext 33 docteurcazier@wanadoo.fr | |
| Hôtel Dieu, Service d'odontologie | Recruiting |
| Toulouse, France, 31059 | |
| Contact: cathy nabet, DDS, PhD nabet@cict.fr | |
| Contact: olivier hamel, DDS, PhD 0561778376 ext 33 hamel.o@chu-toulouse.fr | |
| 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. |
More Information
Additional Information:
Publications:
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01724827 History of Changes |
| Other Study ID Numbers: | P110129 |
| Study First Received: | September 10, 2012 |
| Last Updated: | November 9, 2012 |
| Health Authority: | france : Assistance Publique-Hôpitaux de Paris |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Dental caries inlays composite resins |
IPS-Empress ceramic bicuspid FDI dental restorations evaluation criteria |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013