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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
Faculty Sao Leopoldo Mandic Campinas
About
Eligibility
Locations
Arms
Outcomes
Full info

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

4 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 12, 2019
    Last Updated
    October 11, 2019
    Sponsor
    Faculty Sao Leopoldo Mandic Campinas
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    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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