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Dental CariesPhase 3CECOIANCT01724827

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

A Phase 3 study testing ceramic (Empress CAD, Ivoclar Vivadent) and composite (Lava Ultimate, 3M Espe) in people with Dental Caries and Inlays, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Dental Caries, Inlays
What is being tested?
ceramic (Empress CAD, Ivoclar Vivadent) and composite (Lava Ultimate, 3M Espe)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
355 participants
Where
6 sitesFrance
Study dates
13 Sep 2012to Mar 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
  • subgingival margin after cavity preparation, rubber dam cannot be placed, all tooth cuspids need to be covered by the restoration.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Hôpital Charles Foix (APHP), Service d'odontologie

    Ivry-sur-Seine, 94200

  • Dental pratice

    Lyon, 69003

  • Dental pratice

    Paris, 75012

  • Dental pratice

    Paris, 75015

  • Dental pratice

    Paris, 75017

  • Hôtel Dieu, Service d'odontologie

    Toulouse, 31059

Other trials in France

About this study

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

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.

Read the 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.

Being tested
ceramic (Empress CAD, Ivoclar Vivadent), composite (Lava Ultimate, 3M Espe)
Keywords
Dental caries, inlays, composite resins, IPS-Empress ceramic, bicuspid, FDI dental restorations evaluation criteria
Medical subject headings
Dental Caries, Bicuspid Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT01724827
Study groupRoleWhat they receive
ceramicActive comparatorLeucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)
Receives: Device: ceramic (Empress CAD, Ivoclar Vivadent)
compositeActive comparatorNanohybrid composite resin (Lava Ultimate, 3M Espe)
Receives: Device: composite (Lava Ultimate, 3M Espe)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FDI criteria for dental restorations assessment

    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.

    Measured: at 2 years

Secondary outcomes (4)

  1. Restoration survival analysis

    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.

    Measured: at 2 years

  2. wear

    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.

    Measured: at 2 years

  3. overall quality of the restoration

    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.

    Measured: at 2 years

  4. FDI instrument validity data

    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.

    Measured: at 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2012 (estimated)
  2. Study start13 Sep 2012
  3. Primary completionSep 2016
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
355 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01724827
Sponsor's protocol ID
P110129
Acronym
CECOIA
Status last verified
Mar 2018
First submitted
10 Sep 2012
Last updated
13 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47.

    PubMed 18341239

  • Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.

    PubMed 20628774

  • Fron Chabouis H, Prot C, Fonteneau C, Nasr K, Chabreron O, Cazier S, Moussally C, Gaucher A, Khabthani Ben Jaballah I, Boyer R, Leforestier JF, Caumont-Prim A, Chemla F, Maman L, Nabet C, Attal JP. Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial. Trials. 2013 Sep 3;14:278. doi: 10.1186/1745-6215-14-278.

    PubMed 24004961

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ceramic (Empress CAD, Ivoclar Vivadent) and composite (Lava Ultimate, 3M Espe) in people with Dental Caries and Inlays, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FDI criteria for dental restorations assessment (time frame: at 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01724827, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018; AzTrials last refreshed its copy on 26 Oct 2026.

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