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Effectiveness of Single and Dual Silver Fluoride Application

NCT07658690 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2026-08-31

No results posted yet for this study

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.

Conditions

  • Dentine Caries

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

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-08-31
Completion
2028-02-29

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658690 on ClinicalTrials.gov