NCT04127357

Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces

Progression of Active Microcavitated Carious Lesions on Primary Teeth Occlusal Surfaces: Randomize Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Faculty Sao Leopoldo Mandic Campinas · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries in Children
• Pit and Fissure Sealant
• Toothbrushing

Interventions

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

Timeline

• Start date: 2015-03-05
• Primary completion: 2016-09-01
• Completion: 2019-08-12
• First posted: 2019-10-15
• Last updated: 2019-10-15