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

Study Overview
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Brief Summary
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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
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Failed restorations in primary teeth will be repaired using GIC or composite resin.

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

Conditions
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Dental Caries, Dental Caries in Children

Intervention / Treatment
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* Procedure: Encapsulated Glass Ionomer Cement
* Procedure: Composite resin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success of restorations after repair | 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 | 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 | Wong-Baker facial scale - from 0 to 5 (immediately after treatment) | baseline |