Study of the Success and Survival of Dental Composite Restorations Being Repaired Instead of Being Replaced (RVR)

June 21, 2016 updated by: Pierre-Luc Michaud, Dalhousie University

Replacement Versus Repair of Composite Restorations, a Randomized Controlled Trial

The objective of this trial is to compare the success (as assessed by a pre-defined set of outcome) of failing composite resin restorations that are repaired using diamond bur induced surface abrasion, to those that are completely replaced.

It is hypothesized that both treatment will have comparable success rate.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study is a single-blind randomized non-inferiority trial using parallel groups.

Patients recruited into the study will be randomly assigned to one of two treatment groups. Subjects allocated to Group 1 will have their defective restoration completely replaced while subjects allocated to Group 2 will have their defective restoration repaired.

The success of the treatments will be assessed immediately following the intervention (baseline) and 12 months later.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4R2
        • Dalhousie University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of the Dalhousie University Dental Clinic who are:
  • Age 18 and over
  • Capable of providing informed consent
  • Asymptomatic permanent teeth with class III, IV, V or veneer composite restorations on the facial/buccal surface, requiring treatment (e.g. stain, chipping or color discrepancy).
  • Restoration must present with a portion (mesial, distal, gingival or occlusal) that can be completely retained to allow repair.

Exclusion Criteria:

  • Patients with contra-indications for regular dental treatment based on their medical history
  • Teeth with active caries
  • Teeth with multiple overlapping composite restorations
  • Patients with uncontrolled periodontal disease
  • Restorations smaller than 3mm diameter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repair
Subjects in the Repair group will be given a local anesthetic only if required (i.e. for restorations extending gingivally or on exposed dentin surface) as per usual clinical protocol. The existing restoration will not be removed. The surface of the existing restoration will be roughened with a Brasseler 8856 bur without extending to the surrounding enamel (except is the defect being repaired is adjacent to enamel). No accessory groves/pits for retention will be prepared. To repair the restoration, the surface will be etched using 35% phosphoric acid, and then 3M ESPE Scotchbond Universal Adhesive System followed by 3M ESPE Filtek Supreme Ultra Universal Restorative composite will be used as per the manufacturer's instructions.
Procedure: Repair
Other Names:
  • Scotchbond Universal
  • Filtek Supreme
Active Comparator: Replace
Subjects in the Replace group will be given local anesthetic (an injection of 2% lidocaine with 1:100 000 epinephrine). The type of injection and dosage of anesthetics will be dependent on the tooth being treated, and will follow the usual protocol used in the Dalhousie Dentistry undergraduate clinics. The existing composite restoration will then be removed and the peripheral enamel beveled if not already beveled. To restore the tooth, the surface will be etched using 35% phosphoric acid, and then 3M ESPE Scotchbond Universal Adhesive System followed by 3M ESPE Filtek Supreme Ultra Universal Restorative composite will be used as per the manufacturer's instructions.
Procedure: Replace
Other Names:
  • Scotchbond Universal
  • Filtek Supreme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 12-month
The primary outcome will be the success of the restoration. This will be assessed using the modified U.S. Public Health Service (USPHS) criteria as first described by Cvar and Ryge (1971) and adapted by Wilson et al (2002).
12-month

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 12-month
12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DalDent-2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Failing Dental Composite Restorations

Clinical Trials on Repair

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe