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

NCT04491981 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2021-04-13

No results posted yet for this study

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%).

Conditions

  • Dental Caries
  • Dental Caries in Children

Interventions

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).

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Daniela P Raggio · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-08-01
Completion
2023-08-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04491981 on ClinicalTrials.gov