Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Silver Diamine Fluoride Control treatment |
Other: Silver diamine fluoride
Treatment of initial dental caries lesion in occlusal surface using the silver diamine fluoride.
Other Names:
|
| Active Comparator: Fluoride Varnish Test treatment |
Other: Fluoride Varnish
Treatment of initial dental caries lesion in occlusal surface using the fluoride varnish
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of caries lesions which progressed to dentine [24 months]
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 [12 months]
Parents will be asked to report their satisfaction with the treatment using a VAS scale
Other Outcome Measures
- Direct and Indirect Costs of initial procedures and consequent interventions during 24 months [24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Babies 1 to 3 years;
-
Babies with initial dental caries lesion.
Exclusion Criteria:
- Parents who do not consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of São Paulo | São Paulo | Brazil | 05508000 |
Sponsors and Collaborators
- University of Sao Paulo
- Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
- Principal Investigator: Mariana Minatel Braga, PhD, University of Sao Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SDFtrials-03