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Clinical Trial 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%).


Clinical Trial Description

Failed restorations in primary teeth will be repaired using GIC or composite resin. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04491981
Study type Interventional
Source University of Sao Paulo
Contact Daniela P Raggio
Phone +5511976922202
Email danielar@usp.br
Status Not yet recruiting
Phase N/A
Start date July 1, 2021
Completion date August 1, 2023

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