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NOT YET RECRUITING
NCT07658690
PHASE3

Effectiveness of Single and Dual Silver Fluoride Application

Sponsor: University of Malaya

View on ClinicalTrials.gov

Summary

This is a community-based, parallel-group, double-blinded randomised controlled trial aimed at evaluating the effectiveness of single and dual applications of 38% Silver Fluoride (SF) in arresting dentinal caries among Malaysian preschool children aged 4 to 6 years. The main questions this study aims to answer are: i) Does dual application of 38% Silver Fluoride differ from single application in arresting dentinal caries lesions after 6 months? ii) How does SF application influence oral health-related quality of life (OHRQoL) among preschool children, as measured by the Malay-ECOHIS questionnaire? iii) Is there a correlation between caries arrest and changes in Oral Health-Related Quality of Life (OHRQoL) measured using the Malay-ECOHIS questionnaire? Researchers will compare children receiving a single application of 38% Silver Fluoride with those receiving dual applications to determine whether more frequent application improves caries arrest outcomes. Participants will: i) Undergo oral examination for assessment of dentinal caries using ICDAS criteria. ii) Receive 38% Silver Fluoride application at baseline, with the dual-application group receiving an additional application at 3 months. iii) Attend follow-up assessments at 3 and 6 months to evaluate caries arrest status. iv) Have parents or guardians complete the Malay-ECOHIS questionnaire to assess changes in OHRQoL.

Official title: The Effectiveness of Single and Dual Silver Fluoride (SF) Applications on Dentine Caries Among Malaysian Preschool Children: A Randomised Controlled Trial

Key Details

Gender

All

Age Range

4 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2026-10

Completion Date

2028-02

Last Updated

2026-08-31

Healthy Volunteers

No

Conditions

Interventions

DRUG

38% Silver Fluoride (Riva Star Aqua)

Topical application of 38% silver fluoride will be apply onto dentinal caries lesions using a micro-brush at baseline and 3 months follow up. One drop (0.05 mL) treats up to five surfaces. Maximum dose per visit does not exceed 260 µL.

OTHER

Normal Saline (Placebo)

Participants receive a single application of 38% silver fluoride at dentinal carious lesion at baseline and followed by placebo (normal saline) at 3 months

Locations (1)

Preschools in Perak

Tapah, Perak, Malaysia