Clinical trial

Arrest of Interproximal Caries Lesion in Primary Molars With 38% Silver Diamine Fluoride Solution and 5% Sodium Fluoride Varnish: A Randomized Clinical Trial

Name
PGIDS/BHRC/21/13
Description
This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest. Interproximal caries included in this study, according to ICCMS criteria, were at stages- RA - caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3 - caries limited to outer third of dentine RA4 - caries limited to middle third of dentine
Trial arms
Trial start
2021-08-01
Estimated PCD
2022-08-02
Trial end
2022-11-08
Status
Completed
Phase
Early phase I
Treatment
Silver diamine fluoride
Silver diamine fluoride is a topical medication composed of 25% silver, 5% fluoride, 8% ammonia, and 62% Deionized water, used to treat and prevent dental caries and relieve dentinal hypersensitivity.
Arms:
38% silver diamine fluoride
Other names:
FAgamin SDF38%
Sodium fluoride varnish
It is a topical application with an active ingredient of 5% sodium fluoride(22,600ppm fluoride).it prolongs the contact time between the fluoride and tooth surface and promotes remineralization and inhibits demineralization.
Arms:
5% sodium fluoride varnish
Other names:
VOCO profluorid varnish
Size
45
Primary endpoint
Caries arrest
12 months
Eligibility criteria
Inclusion Criteria: 1. Children aged 5 to 9 years. 2. Presence of at least 2 primary molars with interproximal caries. 3. Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4). Exclusion Criteria: 1. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6). 3. Children or adolescents that refuse to participate in the study or present negative behaviours. 4. Teeth with premature hypermobility 5. Both physically and mentally disabled children
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}
Updated at
2023-03-30

1 organization

2 products

1 indication

Indication
Dental Caries