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Not yet recruiting NCT07658690

Effectiveness of Single and Dual Silver Fluoride Application

Phase III Interventional Dentine Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 38% Silver Fluoride (Riva Star Aqua), Normal Saline (Placebo).
Who it may be relevant to
Registry conditions: Dentine Caries. Basic parameters: 4 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Primary outcome measures

  • Caries arrest at tooth surface level [Time frame: 6 months]
  • Proportion of arrested lesions [Time frame: 6 months]
Secondary outcome measures (2)
  • Change in OHRQoL (Malay-ECOHIS score) [Time frame: Baseline to 6 months]
  • To determine correlation between caries arrest rate and change in total Malay-ECOHIS score [Time frame: 0-6 months]

Eligibility criteria

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Malaysia · 1 center
  • Preschools in Perak — Tapah

Publications

  • Yan IG, Zheng FM, Gao SS, Duangthip D, Lo ECM, Chu CH. A Review of the Protocol of SDF Therapy for Arresting Caries. Int Dent J. 2022 Oct;72(5):579-588. doi: 10.1016/j.identj.2022.06.006. Epub 2022 Jul 14. PMID 35843730

Identifiers

NCT: NCT07658690 · DF CO2505/0018 (P)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗