NCT05655286

Effectiveness of SDF With Different Post-treatment Protocols in Arresting Dental Caries

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 3 Years – 4 Years
• Healthy volunteers: Accepted

Summary

To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children

Detailed description

Methods: The randomized clinical trial will recruit 254 healthy kindergarten children aged 3-4 years old with caries and with parental consent. All the tooth surfaces with carious lesions will receive the semi-annual application of 38% SDF solution. After the treatment, children will be allocated to two groups by an independent research assistant. Two post-treatment protocols are as follows. 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

• Dental Caries

Interventions

Type	Name	Description
DRUG	38% SDF treatment	Children with active caries will receive 38% silver diamine fluoride treatment
BEHAVIORAL	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.
BEHAVIORAL	rinse mouth immediately after SDF treatment	After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-05-20
• Completion: 2024-05-20
• First posted: 2022-12-19
• Last updated: 2024-05-22

Locations

1 site across 1 country: China