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

April 12, 2021 updated by: Daniela Prócida Raggio, University of Sao Paulo

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

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%).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daniela P Raggio
  • Phone Number: +5511976922202
  • Email: danielar@usp.br

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-000
        • University of São Paulo - School of Dentistry
        • Contact:
          • Daniela P Raggio, Professor
          • Phone Number: + 55 11 976922202
          • Email: danielar@usp.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost- effectiveness of restorations repairs
Time Frame: 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)
24 months
Patient's discomfort
Time Frame: baseline
Wong-Baker facial scale - from 0 to 5 (immediately after treatment)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Daniela P Raggio, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REPAIRC3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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