NCT04491981

Restoration Repairs Using Composite Resin Versus Glass Ionomer in Primary Molars: a Randomized Clinical Trial

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Caries
• Dental Caries in Children

Interventions

Type	Name	Description
PROCEDURE	Encapsulated Glass Ionomer Cement	Repair of restorations in primary molars using Encapsulated High Viscosity Glass Ionomer (RIVA Self Cure - SDI). No local anesthesia will be used. A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with GIC (Glass Ionomer Cement).
PROCEDURE	Composite resin	Repair of restorations in primary molars using composite resin (Filtek Bulk Fill- 3M ESPE.) No local anesthesia will be used.A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with CR (composite resin).

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-08-01
• Completion: 2023-08-01
• First posted: 2020-07-30
• Last updated: 2021-04-13

Locations

1 site across 1 country: Brazil