Clinical trial NCT04127357: Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces
Official title: Progression of Active Microcavitated Carious Lesions on Primary Teeth Occlusal Surfaces: Randomize Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Pit and Fissure Sealant
Toothbrushing
Keywords: Pit and fissure sealants
Pediatric dentistry
Toothbrushing
Lead sponsor: Faculty Sao Leopoldo Mandic Campinas
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical evaluation of caries progression
timeFrame: 6 months
measure: Clinical evaluation of caries progression
timeFrame: 12 months
Secondary outcomes:
measure: Sealant retention
timeFrame: 6 months
measure: Sealant retention
timeFrame: 12 months
Other outcomes:
measure: Direct cost estimate
timeFrame: 6 months
measure: Direct cost estimate
timeFrame: 12 months
Locations:
Study officials:
affiliation: Sao Leopoldo Mandic
name: Jose Carlos P Imparato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer-Lueckel H, Paris S. When and How to Intervene in the Caries Process. Oper Dent. 2016 Sep;41(S7):S35-S47. doi: 10.2341/15-022-O.
citation: Bakhshandeh A, Qvist V, Ekstrand KR. Sealing occlusal caries lesions in adults referred for restorative treatment: 2-3 years of follow-up. Clin Oral Investig. 2012 Apr;16(2):521-9. doi: 10.1007/s00784-011-0549-4. Epub 2011 Apr 9.