Clinical trial NCT03005405: Cost-efficacy of Sealing Moderate Caries Lesions in Occlusal Surfaces of Primary Molars
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: Dental Caries
Primary tooth
Ionomer Sealants
Glass Ionomer Restoration
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 96
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Need of reintervention
timeFrame: 24 months
Secondary outcomes:
measure: Child's reported discomfort
timeFrame: 1st day
measure: Duration of treatments
timeFrame: 1st day
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Mariana M Braga, PhD
role: PRINCIPAL_INVESTIGATOR
References: