Back to resultsDiammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Silver diamine fluoride
Fluoride Varnish
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring dental caries, deciduous tooth
Eligibility Criteria
Inclusion Criteria:
- Babies 1 to 3 years;
- Babies with initial dental caries lesion.
Exclusion Criteria:
- Parents who do not consent.
Sites / Locations
- University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Silver Diamine Fluoride
Fluoride Varnish
Arm Description
Control treatment
Test treatment
Outcomes
Primary Outcome Measures
Number of caries lesions which progressed to dentine
Assessment of caries lesions severity in order to identify those which progressed to dentine (ICDAS scores 4 to 6)
Secondary Outcome Measures
Parental acceptability to the treatment using a VAS scale
Parents will be asked to report their satisfaction with the treatment using a VAS scale
Full Information
NCT ID
NCT02789202
First Posted
May 25, 2016
Last Updated
March 20, 2018
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02789202
Brief Title
Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces
Official Title
Efficacy, Cost-efficacy and Parental Acceptability of Using Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides, the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this, 100 babies 1-3 years will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis will be conducted using the International Caries Detection and Assessment System (ICDAS). Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6, 12, 18 and 24 months. As primary outcome, caries progression into dentine will be considered. Acceptability reported by parents after treatments, the time and estimated money spent for treating will also be collected. Social and biological data that could be related to efficacy of techniques will be also collected. Multilevel analyses will be performed to check which technique will be most effective and possible factors associated to its efficacy. Discomfort, acceptability and costs will be compared between/among the approaches used to arrest enamel caries lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, deciduous tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Silver Diamine Fluoride
Arm Type
Experimental
Arm Description
Control treatment
Arm Title
Fluoride Varnish
Arm Type
Active Comparator
Arm Description
Test treatment
Intervention Type
Other
Intervention Name(s)
Silver diamine fluoride
Other Intervention Name(s)
SDF
Intervention Description
Treatment of initial dental caries lesion in occlusal surface using the silver diamine fluoride.
Intervention Type
Other
Intervention Name(s)
Fluoride Varnish
Other Intervention Name(s)
sodium fluoride
Intervention Description
Treatment of initial dental caries lesion in occlusal surface using the fluoride varnish
Primary Outcome Measure Information:
Title
Number of caries lesions which progressed to dentine
Description
Assessment of caries lesions severity in order to identify those which progressed to dentine (ICDAS scores 4 to 6)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Parental acceptability to the treatment using a VAS scale
Description
Parents will be asked to report their satisfaction with the treatment using a VAS scale
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Direct and Indirect Costs of initial procedures and consequent interventions during 24 months
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Babies 1 to 3 years;
Babies with initial dental caries lesion.
Exclusion Criteria:
Parents who do not consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana Minatel Braga, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
ZIP/Postal Code
05508000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces
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