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

Not Applicable

• Conditions: Dental Caries; Dental Caries in Children
• Interventions: Procedure: Composite resin; Procedure: Encapsulated Glass Ionomer Cement

• Registration Number: NCT04491981
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-13
• Study Start: 2021-07-01
• Primary Completion: 2022-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Composite resin	Composite resin	Repair of restorations in primary molars using a composite resin (Filtek Bulk Fill- 3M ESPE)
Encapsulated Glass Ionomer Cement	Encapsulated Glass Ionomer Cement	Repair of restorations in primary molars using a high viscosity glass ionomer cement (RIVA Self Cure - SDI)

Primary Outcome Measures

Name	Time	Method
Clinical success of restorations after repair	24 months	Visual assessment using Frencken criteria for occlusal restoration and Roeleveld et al. criteria for occlusoproximal restorations

Secondary Outcome Measures

Name	Time	Method
Cost- effectiveness of restorations repairs	24 months	To assess this outcome measure we will consider the percentage of patients needing new operatory interventions and costs will be assessed in monetary units (US dollars)
Patient's discomfort	baseline	Wong-Baker facial scale - from 0 to 5 (immediately after treatment)

Trial Locations

Locations (1)

University of São Paulo - School of Dentistry; 🇧🇷 São Paulo, Brazil