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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Ministry of Health, France
Hôpital Charles Foix - Service d'odontologie (APHP)
Hôtel Dieu - Service d'odontologie (Toulouse)
Dental practitionners
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01724827
First received: September 10, 2012
Last updated: September 17, 2013
Last verified: May 2012
  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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: September 2016
Estimated Primary Completion Date: September 2016 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724827

Contacts
Contact: jean-pierre attal, DDS, PhD 01 58 07 67 82 ext 33 jean-pierre.attal@parisdescartes.fr

Locations
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   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Hôpital Charles Foix - Service d'odontologie (APHP)
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.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 17, 2013
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 July 09, 2014