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

Replacement Versus Repair of Composite Restorations, a Randomized Controlled Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02046109
Acronym
RVR
Enrollment
0
Registered
2014-01-27
Start date
2014-09-30
Completion date
2017-12-31
Last updated
2016-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failing Dental Composite Restorations

Keywords

Repair, Replace, Composite, restoration, failing dental restoration, filling, dental, dentistry

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.

Interventions

PROCEDURERepair
PROCEDUREReplace

Sponsors

Dalhousie University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success rate12-monthThe 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

MeasureTime frame
Survival12-month

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026