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

Not Applicable

Withdrawn

• Conditions: Failing Dental Composite Restorations

• Registration Number: NCT02046109
• Lead Sponsor: Dalhousie University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Study Start: 2014-09
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-06-22
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Success rate	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).

Secondary Outcome Measures

Name	Time	Method
Survival	12-month

Trial Locations

Locations (1)

Dalhousie University Faculty of Dentistry; 🇨🇦 Halifax, Nova Scotia, Canada