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

University of Sao Paulo96 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Caries

Interventions

Ionomer Restoration (control)PROCEDURE

Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements

Ionomer Sealant (test)PROCEDURE

Sealing of moderate caries lesions without any caries removal or cavity opening.

Oral hygiene orientation and professional fluoride applicationPROCEDURE

Oral hygiene orientation and professional fluoride application

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of São Paulo

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

Child's reported discomfort

The discomfort will be an outcome collected right after the end of treatment, using Wong baker scale

Time frame: 1st day

Duration of treatments

Time spent in interventions will be recorded.

Time frame: 1st day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.