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Clinical Trials/NCT04491981
NCT04491981
Unknown
Not Applicable

Longevity of Restoration Repairs Using Composite Resin Versus High Viscosity Glass Ionomer in Primary Molars: Randomized Clinical Trial

University of Sao Paulo1 site in 1 country312 target enrollmentJuly 1, 2021

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
August 1, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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