Cost-efficacy of Sealing Moderate Caries Lesions in Occlusal Surfaces of Primary Molars

Study Overview
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Brief Summary
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This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. Initially, a non-inferiority study was designed in order to verify if sealing could be non-inferior than restoration. In this case, it could be preferable since it is less invasive. Therefore, cost will be put forward into the analysis considering even reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability could be another differential point between treatments.

Detailed Description
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This study aims to evaluate the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. 96 children aged 3-6 years will be selected. Children must have at least one occlusal surface classified as scores 3 or 4 of International Caries Detection and Assessment System (ICDAS). Children will be randomly allocated according to the treatment: glass ionomer sealant and restoration with glass ionomer. After treatment, teeth will be assessed clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the treatment received. The need of reintervention initially treated, either by failures that require repeating of the same procedure or for progression of caries lesions will be considered as primary outcomes. The secondary outcomes will be the chil's acceptability to the treatment.

Official Title
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Cost-efficacy and Applicability of the Treatment of Moderate Caries Using Sealants as an Alternative to the Restorations on Occlusal Surfaces of Deciduous Teeth: a Randomized Controlled Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Procedure: Ionomer Restoration (control)
* Procedure: Ionomer Sealant (test)
* Procedure: Oral hygiene orientation and professional fluoride application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They will be included in this study children: aged 3 years and 6 years and 11 months; With complete primary dentition; Who have at least one active caries lesion score 3 or 4 ICDAS, in the occlusal molars surfaces. Who have assented to participate and whose parents have consented to their participation by signing the Instrument of Consent. Exclusion Criteria: who have medical and / or behavioral conditions that require special considerations regarding handling / treatment; who are involved in other research that may impact on this study; whose parents that not agree in participate.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: restoration - control<br>Restoration | Procedure: Ionomer Restoration (control)<br>* Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements<br>* Other names: glass ionomer cement, restoration;Procedure: Oral hygiene orientation and professional fluoride application<br>* Oral hygiene orientation and professional fluoride application<br>|
| Experimental: sealant - test<br>Sealant | Procedure: Ionomer Sealant (test)<br>* Sealing of moderate caries lesions without any caries removal or cavity opening.<br>* Other names: glass ionomer cement, sealant;Procedure: Oral hygiene orientation and professional fluoride application<br>* Oral hygiene orientation and professional fluoride application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of reintervention | Need of reintervention will be considered as all failures after initial treatment that demand repair and/or caries progression associated to the treated lesion at baseline. After cleaning, It will be analyzed the clinical evaluation of restorations and sealants, will be assessed the presence of caries lesions in dentin and / or evolution of ICDAS scores and if will be necessary other types of treatment, such as endodontics and extraction of teeth included. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child's reported discomfort | The discomfort will be an outcome collected right after the end of treatment, using Wong baker scale | 1st day | 
| Duration of treatments | Time spent in interventions will be recorded. | 1st day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Caries, Primary tooth, Ionomer Sealants, Glass Ionomer Restoration