The Effectiveness of Single and Dual Silver Fluoride (SF) Applications on Dentine Caries Among Malaysian Preschool Children: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- University of Malaya
- 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
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
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
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
Nurfazlina binti Rosman
Principal Investigator
University of Malaya