Longevity of Restoration Repairs Using Composite Resin Versus High Viscosity Glass Ionomer in Primary Molars: Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Caries
- Sponsor
- University of Sao Paulo
- Enrollment
- 312
- Locations
- 1
- Primary Endpoint
- Clinical success of restorations after repair
- Last Updated
- 5 years ago
Overview
Brief Summary
The objective of this randomized clinical study is to evaluate the survival of repairs in restorations using composite resin (CR) or high viscosity glass ionomer cement (GIC) in primary molars. This trial is nested to another study (NCT03520309), so patients will be enrolled from CARDEC 3. 312 restorations will be included and randomized into two groups: glass ionomer cement (Riva Self Cure, SDI, Australia) and composite resin (Filtek Bulk Fill and Filtek Bulk Fill Flow, 3M ESPE, USA). After the end of treatments, patients will be followed for 24 months to assess the success of the restorations, which will be considered as the absence of the need for reintervention. The Kaplan-Meier survival curves and the log-rank tests will be performed to assess survival between groups and Cox regression analysis will be used to compare the outcome with the variables (α = 5%).
Detailed Description
Failed restorations in primary teeth will be repaired using GIC or composite resin.
Investigators
Daniela Prócida Raggio
Professor Doctor
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Children who have sought treatment in the School of Dentistry, University of Sao Paulo
- •Children between 3 and 10 years old
- •Children presenting at least one restoration (of any material, any surface and any integrity status) in primary teeth
Exclusion Criteria
- •Children whose parents did not agree to participate in the study
- •Children with behavioural issues at the initial exam or who did not assent to participate in the study
Outcomes
Primary Outcomes
Clinical success of restorations after repair
Time Frame: 24 months
Visual assessment using Frencken criteria for occlusal restoration and Roeleveld et al. criteria for occlusoproximal restorations
Secondary Outcomes
- Cost- effectiveness of restorations repairs(24 months)
- Patient's discomfort(baseline)