Effectiveness of SDF With Different Post-treatment Protocols in Arresting Dental Caries
NCT ID: NCT05655286
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
254 participants
INTERVENTIONAL
2023-01-01
2024-05-20
Brief Summary
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Detailed Description
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Group A - Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.
Group B - Children are instructed not to eat and drink for at least 30 minutes. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 12-months follow-up. The analysis will determine the significance of differences between the percentage of arrested caries at the various follow-ups.
Significance: This study will help determine the optimal post-op treatment in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A- immediately rinse mouth
Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.
38% SDF treatment
Children with active caries will receive 38% silver diamine fluoride treatment
rinse mouth immediately after SDF treatment
After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.
Group B- not to rinse for at least 30 minutes
Children are instructed not to eat and drink for at least 30 minutes.
38% SDF treatment
Children with active caries will receive 38% silver diamine fluoride treatment
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.
Interventions
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38% SDF treatment
Children with active caries will receive 38% silver diamine fluoride treatment
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.
rinse mouth immediately after SDF treatment
After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Years
4 Years
ALL
Yes
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Chun Hung Chu
Professor
Locations
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The university of Hong Kong
Hong Kong, , China
Countries
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References
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Sun IG, Duangthip D, Lo ECM, Chu CH. The Caries-Arrest Effectiveness of Silver Diamine Fluoride Treatment with Different Post-Treatment Instructions in Preschool Children: A Study Protocol for a Randomized Controlled Trial. Dent J (Basel). 2023 Jun 5;11(6):145. doi: 10.3390/dj11060145.
Other Identifiers
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HKU20221001
Identifier Type: -
Identifier Source: org_study_id
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