An interventional study of 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil). in Dental Caries in Children, Pit and Fissure Sealant and Toothbrushing, sponsored by Faculty Sao Leopoldo Mandic Campinas. Completed. Open to participants aged 4 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by Faculty Sao Leopoldo Mandic Campinas · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
Brushing with 1450 ppm fluoride toothpaste.
Procedure: 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).
Resin sealing (FluroShield, Dentsply, Brazil).
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.
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
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: 12 months
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
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: 12 months
Direct cost estimate
To estimate costs, the sessions were timed (initial and reevaluations) and for each consultation a table was filled in, which should contain the quantities of materials used per session. Prices of materials were considered by inferring the market value obtained by an average of 3 (three) different places that market the products in question, thus obtaining different costs for the proposed treatments.
Time frame: 6 months
Direct cost estimate
To estimate costs, the sessions were timed (initial and reevaluations) and for each consultation a table was filled in, which should contain the quantities of materials used per session. Prices of materials were considered by inferring the market value obtained by an average of 3 (three) different places that market the products in question, thus obtaining different costs for the proposed treatments.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Faculty Sao Leopoldo Mandic Campinas