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

Sponsor
University of Sao Paulo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04491981
Collaborator
(none)
312
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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%).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Encapsulated Glass Ionomer Cement
  • Procedure: Composite resin
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
312 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Longevity of Restoration Repairs Using Composite Resin Versus High Viscosity Glass Ionomer in Primary Molars: Randomized Clinical Trial
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. Patient's discomfort [baseline]

    Wong-Baker facial scale - from 0 to 5 (immediately after treatment)

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of São Paulo - School of Dentistry São Paulo Brazil 05508-000

Sponsors and Collaborators

  • University of Sao Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Daniela Prócida Raggio, Professor Doctor, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT04491981
Other Study ID Numbers:
  • REPAIRC3
First Posted:
Jul 30, 2020
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dental Caries

Study Results

No Results Posted as of Apr 13, 2021