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Clinical trial

The Effectiveness of Silver Diamine Fluoride Treatment With Different Post-treatment Protocols in Arresting Dental Caries in Primary Teeth of Preschool Children

ID
Name
HKU20221001
Description
To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-05-20
Trial end
2024-05-20
Status
Completed
Treatment
38% SDF treatment
Children with active caries will receive 38% silver diamine fluoride treatment
Arms:
Group A- immediately rinse mouth, Group B- not to rinse for at least 30 minutes
not to rinse for at least 30 minutes after SDF treatment
After receiving 38% silver diamine fluoride treatment, Children will be asked not to rinse their mouths for at least 30 minutes.
Arms:
Group B- not to rinse for at least 30 minutes
rinse mouth immediately after SDF treatment
After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.
Arms:
Group A- immediately rinse mouth
Size
254
Primary endpoint
Caries status
at 12-month follow-up
Eligibility criteria
Inclusion Criteria: 1. 3-5 year old children attending the first to the third year of kindergarten; 2. free from any systemic conditions and generally healthy; 3. parents sign informed consent; 4. having at least 1 tooth with cavitated dentine carious lesion Exclusion Criteria: 1. are uncooperative to accept oral examination or treatment; 2. have a significant systematic disease or long-term medications; 3. have abnormal dentition. 4. Teeth having signs or symptoms of irreversible pulpitis and non-vitality will be excluded.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 254, 'type': 'ACTUAL'}}
Updated at
2024-05-22

1 organization

1 product

1 indication

Organization
The University of Hong Kong
Product
SDF treatment
Indication
Tooth Decay