A Phase 3 interventional study of 38% Silver Fluoride (Riva Star Aqua) and Normal Saline (Placebo) in Dentine Caries, sponsored by University of Malaya. Not yet recruiting at 1 site in Malaysia. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University of Malaya · Phase 3, Interventional, and Treatment
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.
University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Single applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and followed by placebo (normal saline) at 3 months
Drug: 38% Silver Fluoride (Riva Star Aqua) · Other: Normal Saline (Placebo)
Two applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and 3 months.
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.
Participants receive a single application of 38% silver fluoride at dentinal carious lesion at baseline and followed by placebo (normal saline) at 3 months
Caries arrest at tooth surface level
Lesions are considered arrested if they are hard upon probing using WHO probe and have turned black in colour. Each tooth may contribute up to five surfaces, with analysis conducted at the lesion level.
Time frame: 6 months
Proportion of arrested lesions
Caries arrest will be assessed at the tooth surface level. The outcome is defined as the proportion of lesions classified as arrested out of the total treated lesions in each group. Comparisons will be made between single and dual application groups. Analyses will be conducted at both surface (lesion) level and participant level, accounting for clustering of lesions within individuals.
Time frame: 6 months
Change in OHRQoL (Malay-ECOHIS score)
Change in total Malay-ECOHIS score from baseline to 6 months will be assessed. The Malay-ECOHIS is a validated parent-reported questionnaire measuring the impact of oral health on children and their families. Scores range from 0 to 52, with higher scores indicating worse oral health-related quality of life. A reduction in score reflects improvement in OHRQoL.
Time frame: Baseline to 6 months
To determine correlation between caries arrest rate and change in total Malay-ECOHIS score
This outcome will assess the correlation between caries arrest rate at 6 months and change in total Malay-ECOHIS score from baseline to 6 months. Caries arrest rate (%) will be assessed by clinical examination and calculated as the number of arrested treated dentinal caries lesions divided by the total number of treated dentinal caries lesions per participant, multiplied by 100. The unit of measure is percentage (%) of arrested treated dentinal caries lesions. Change in total Malay-ECOHIS score will be assessed using the Malay-ECOHIS questionnaire. The change score will be calculated as the total score at 6 months minus the baseline total score. The unit of measure is change in total Malay-ECOHIS score. Pearson correlation will be used if normality assumptions are met; otherwise, Spearman rank correlation will be used.
Time frame: 0-6 months
Plan to share: No — Individual participant data will not be publicly shared due to participant confidentiality and ethical considerations
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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