Effectiveness of Single and Dual Silver Fluoride Application

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Dentine Caries

In brief

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.

Key facts

Study ID

NCT07658690

Run by

University of Malaya

People needed

138

Starts

2026-09-01

Expected to finish

2028-02-01

Last updated by the study team

2026-07-08

Who can join

Age: 4 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 4-6 years enrolled in selected preschools.
• Presence of at least one active dentinal caries lesion.
• Parental or guardian consent obtained.
• Asymptomatic cavitated dentine carious lesions in primary teeth.
• Parents/caregivers who understand the Malay language.

You may not qualify if…

• Clinical signs or symptoms of irreversible pulpitis or dental abscess/fistula.
• Systemic illness or medical contraindications for SF use.
• Developmental abnormalities of tooth structure, including amelogenesis imperfecta or dentinogenesis imperfecta.
• History of allergy or sensitivity to dental materials, including silver or fluoride contained in silver fluoride (SF).
• Children who have received professionally applied fluoride within the past six months at the time of recruitment.
• Arrested caries lesion.
• Children presenting with oral ulceration or mucositis.
• Uncooperative behaviour precluding oral examination.
• Children with pre-shedding tooth mobility

Where it is running

• Preschools in Perak — Tapah, Perak, Malaysia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.