Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces

Not Applicable

Completed

• Conditions: Dental Caries in Children; Toothbrushing; Pit and Fissure Sealant
• Interventions: Procedure: 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).

• Registration Number: NCT04127357
• Lead Sponsor: Faculty Sao Leopoldo Mandic Campinas

Brief Summary

Objective: To verify the progression of active microcavitated carious lesions on occlusal surfaces of primary molars after the orientation of the brushing technique associated with fluoride dentifrice compared to resin sealant, through a 12-month randomized clinical trial. Methodology: We selected 22 children from 4 to 9 years old from the public school system of the city of Juazeiro do Norte-Ceará, with at least one primary molar presenting an active caries lesion score 3 of the International Caries Detection and Assessment System (ICDAS). Randomization was performed en bloc and stratified by two conditions (age and caries experience). The selected teeth were divided into two groups: the first (G1) was submitted to brushing with fluoridated toothpaste; and the other group (G2) to the resin sealing technique, whose application of the material was performed under absolute or relative isolation, selected through a second randomization. The molars undergoing treatment were evaluated at 6- and 12-month returns. Caries progression was evaluated according to the type of treatment, dental group and sealant retention by the Chi-square test. For cost analysis, the variance test (ANOVA) was used.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-05
• Primary Completion: 2016-09-01
• Study Completion: 2019-08-12
• Study First Submitted: 2019-08-12
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-11
• Last Update Submitted: 2019-10-11
• Study First Posted: 2019-10-15
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• At least one primary molar with active caries lesions classified as ICDAS score 3.

Exclusion Criteria

• Children with differentiated management needs and/or systemic diseases with oral involvement.
• Primary molar with active caries lesions classified as ICDAS score 3 that had other caries lesions involving dentin, restorations, sealants, or other types of formation defects.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B - Test	1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).	Resin sealing (FluroShield, Dentsply, Brazil).
A - Control	1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).	Brushing with 1450 ppm fluoride toothpaste.

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of caries progression	12 months	With the radiographs in hand, the possible progression of the treated caries lesion was observed, which was coded as: a) Absent progression: no radiolucent area of the lesion; b) Present progression: with increase in the radiolucent area of the lesion.

Secondary Outcome Measures

Name	Time	Method
Sealant retention	12 months	Clinical evaluation of sealant retention was performed using the criteria used by Pardi: RT- total retention, PP1- presence of sealant on two thirds of the occlusal surface, PP2- presence of sealant on one third of the occlusal surface. PT-total loss of sealant on occlusal surface.