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Clinical Trials/NCT07658690
NCT07658690Not yet recruitingPhase 3

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

University of Malaya1 site in 1 country148 target enrollmentStarted: October 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
148
Locations
1

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

This is a double-blinded study. Participants and outcome assessors will be blinded to group allocation. A placebo, normal saline in a foil-wrapped bottle, will be used at the 3-month visit in the single-application group to maintain blinding

Eligibility Criteria

Ages
4 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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 three 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

Arms & Interventions

Single Application of Silver Fluoride

Placebo Comparator

Single applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and followed by placebo (normal saline) at 3 months

Intervention: Normal Saline (Placebo) (Other)

Dual Application of Silver Fluoride

Experimental

Two applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and 3 months.

Intervention: 38% Silver Fluoride (Riva Star Aqua) (Drug)

Single Application of Silver Fluoride

Placebo Comparator

Single applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and followed by placebo (normal saline) at 3 months

Intervention: 38% Silver Fluoride (Riva Star Aqua) (Drug)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nurfazlina binti Rosman

Principal Investigator

University of Malaya

Study Sites (1)

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