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NCT06797882
Preventive Effects of Silver Diamine Fluoride on Early Enamel Caries
Phase 2 trial testing Silver diamine fluoride- potassium iodide in Demineralization, Tooth in 99 participants. Not yet recruiting.
31 August 2026
Quick facts
| Lead sponsor | National University of Malaysia |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 99 |
| Start date | 31 January 2025 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- Silver diamine fluoride- potassium iodide — full drug profile →
- Fluoride varnish
- 0.9 % saline
Conditions studied
- Demineralization, Tooth — all drugs for Demineralization, Tooth →
- White Spot Lesion of Tooth — all drugs for White Spot Lesion of Tooth →
- Fixed Appliances — all drugs for Fixed Appliances →
- Early Caries Lesions — all drugs for Early Caries Lesions →
Sponsor
National University of Malaysia
Who can join
18 and older, any sex, with Demineralization, Tooth or White Spot Lesion of Tooth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Fixed orthodontic patients are at risk of developing dental caries. Topical application of fluoride varnish (FV) around the orthodontic brackets and using fluoridated mouth rinses have been suggested to prevent the formation of white spot lesions (WSLs) on enamel. Recent studies have shown that silver diamine fluoride (SDF) demonstrated better outcomes in dental caries prevention as compared to FV. However, the caries preventive effects of SDF application around the orthodontic brackets have not been established yet. This study will be conducted to evaluate the effectiveness of SDF in preventing WSLs formation in patients undergoing fixed orthodontic treatment. This study will use a randomised-controlled double-blinded design with three parallel arms. Ninety-nine eligible participants will be recruited. Using their registration number, a random list of patients will be generated using computer software. Each patient will be assigned randomly to three groups: SDF, FV, or placebo. Digital photographs of upper anterior teeth (frontal view) will be taken as a baseline and repeated at every review appointment. The materials will be applied around the orthodontic bracket of upper incisors and canines every 6 months. The formation of WSLs around the bracket will be evaluated at 1, 3, 6, and 12 months using three parameters: the ICDAS scoring system, the laser fluorescence caries detector, and digital photographic analysis using the Gorelick score. The patients' perception of the colour changes of the enamel will be evaluated through patient-reported outcomes. The difference in ICDAS and Gorelick scores and the patients' perceptions will be reported through descriptive statistics. The Kruskal-Wallis or one-way ANOVA statistical test will be used to compare the changes in fluorescence intensity between treatment groups. The investigators believe that the results of this study will provide insight into the caries preventive protocol among fixed orthodontics patients and subsequently reduce the incidence of WSLs during orthodontic treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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Related trials
Other trials of Silver diamine fluoride- potassium iodide
Trials testing the same drug.
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- NCT05296213 — Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents · NA · completed
Other National University of Malaysia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06797882 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National University of Malaysia
- Last refreshed: 30 January 2025
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