Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces
Primary Purpose
Dental Caries in Children, Pit and Fissure Sealant, Toothbrushing
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries in Children focused on measuring Pit and fissure sealants, Pediatric dentistry, Toothbrushing
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
A - Control
B - Test
Arm Description
Brushing with 1450 ppm fluoride toothpaste.
Resin sealing (FluroShield, Dentsply, Brazil).
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04127357
First Posted
August 12, 2019
Last Updated
October 11, 2019
Sponsor
Faculty Sao Leopoldo Mandic Campinas
1. Study Identification
Unique Protocol Identification Number
NCT04127357
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 5, 2015 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
August 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Sao Leopoldo Mandic Campinas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children, Pit and Fissure Sealant, Toothbrushing
Keywords
Pit and fissure sealants, Pediatric dentistry, Toothbrushing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A - Control
Arm Type
Other
Arm Description
Brushing with 1450 ppm fluoride toothpaste.
Arm Title
B - Test
Arm Type
Experimental
Arm Description
Resin sealing (FluroShield, Dentsply, Brazil).
Intervention Type
Procedure
Intervention Name(s)
1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical evaluation of caries progression
Description
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
Title
Clinical evaluation of caries progression
Description
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
Secondary Outcome Measure Information:
Title
Sealant retention
Description
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
Title
Sealant retention
Description
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
Other Pre-specified Outcome Measures:
Title
Direct cost estimate
Description
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
Title
Direct cost estimate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Carlos P Imparato, PhD
Organizational Affiliation
Sao Leopoldo Mandic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27689929
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.
Results Reference
result
PubMed Identifier
21479565
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.
Results Reference
result
Learn more about this trial
Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces
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