NCT04127357

Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces

Completed NA Last updated 15 October 2019

What this trial tests

NA trial testing 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil). in Dental Caries in Children in 22 participants. Completed in 12 August 2019.

Timeline

5 March 2015

Primary endpoint
1 September 2016

12 August 2019

Quick facts

Lead sponsor	Faculty Sao Leopoldo Mandic Campinas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	22
Start date	5 March 2015
Primary completion	1 September 2016
Estimated completion	12 August 2019

Drugs / interventions tested

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

Conditions studied

• Dental Caries in Children — all drugs for Dental Caries in Children →
• Pit and Fissure Sealant — all drugs for Pit and Fissure Sealant →
• Toothbrushing — all drugs for Toothbrushing →

Sponsor

Faculty Sao Leopoldo Mandic Campinas

Who can join

Adults 4 to 9, any sex, with Dental Caries in Children or Pit and Fissure Sealant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.