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Effectiveness of Single and Dual Silver Fluoride Application

StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment target: 138 to 148
    • Primary completion date: Sep 2027 to Aug 2027
    • Start date: Sep 2026 to Oct 2026
    v4
  2. Eligibility criteria revisedv3
  3. Interventions: 38% Silver Fluoride (Riva Star Aqua) (Drug), Normal saline (palcebo) (Other) to 38% Silver Fluoride (Riva Star Aqua) (Drug), Normal Saline (Placebo) (Other)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07658690
Lead Sponsor University of Malaya
Conditions
(from sponsor)		 Dentine Caries
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov