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

Failing Dental Composite Restorations Clinical Trial

— RVR  

Official title:

Replacement Versus Repair of Composite Restorations, a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02046109
• Other study ID #: DalDent-2014-01
• Status: Withdrawn
• Phase: N/A
• First received: January 23, 2014
• Last updated: June 21, 2016
• Start date: September 2014
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Dalhousie University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failing Dental Composite Restorations

Intervention

Procedure:
• Repair

• Replace

Locations

Country	Name	City	State
Canada	Dalhousie University Faculty of Dentistry	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Dalhousie University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	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	No
Secondary	Survival		12-month	No

External Links

•   Dalhousie University Faculty of Dentistry Web Site