Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces

Faculty Sao Leopoldo Mandic Campinas22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Caries in Children Pit and Fissure Sealant

Interventions

1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).PROCEDURE

After randomization of the children, the selected molars were allocated through a randomized sequence list in 2 groups: A. Brushing with 1450 ppm fluoride toothpaste, donated by the researcher; B. Resin Sealing (FluroShield, Dentsply, Brazil). The teeth included in the second group (group B) underwent a second randomization: B1. With absolute isolation; B2. With relative isolation. For the group with absolute isolation, topical anesthesia and local papillary infiltration were performed for subsequent staple placement. Relative isolation was performed with cotton rollers and moisture control suction. The sealant selected was the opaque fluroshield to facilitate visualization upon visual examination during reevaluations and was applied following the manufacturer's standards. The teeth were clinically and radiographically followed at 6 and 12 months and two sessions of motivation reinforcement were performed through video and brush change at 3 and 9 months.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinical evaluation of caries progression

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.

Time frame: 6 months

Clinical evaluation of caries progression

Time frame: 12 months

Secondary Outcomes

Sealant retention

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.

Time frame: 6 months

Sealant retention

Time frame: 12 months