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NCT06316323
The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish
Phase 1 trial testing Silver diamine fluoride in Early Childhood Caries in 49 participants. Completed in 26 January 2024.
29 September 2023
Quick facts
| Lead sponsor | Universiti Teknologi Mara |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 1 February 2023 |
| Primary completion | 29 September 2023 |
| Estimated completion | 26 January 2024 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- Silver diamine fluoride — full drug profile →
- Sodium fluoride — full drug profile →
Conditions studied
- Early Childhood Caries — all drugs for Early Childhood Caries →
Sponsor
Universiti Teknologi Mara
Who can join
Adults 4 to 6, any sex, with Early Childhood Caries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Sodium Fluoride (NAF) varnish was considered as the treatment of Early Childhood Caries (ECC). However, the emergence of Silver Diamine Fluoride (SDF) has become more popular to tackle dental caries among children. SDF has silver ions that harbor antibacterial properties that play a crucial role in arresting active, cavitated carious lesions and has fluoride ions that are important in remineralizing enamel and dentin. This randomized control trial aims to compare the effect of SDF and NaF varnish on the salivary pH and density of Streptococcus mutans and Lactobacillus. 49 subjects below 6 years old, attending dental treatment at the Faculty of Dentistry, Universiti Teknologi MARA (UiTM) were recruited and were divided into two groups of treatment: 38% SDF or 5% SDF. Saliva samples of each subject were collected to test for salivary pH and density of S. mutans and Lactobacillus before the treatment and after 3 months of treatment. The salivary pH were tested using a calibrated pH meter. Saliva samples were subjected to microbiological analysis using Colony Forming Unit (CFU) and quantitative Polymerase Chain Reaction (qPCR) technique. The findings of this study will be used to support the use of SDF as an alternative to NaF varnish and to develop a recommendation guideline on the clinical use of SDF in ECC management.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06316323
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Related trials
Other trials of Silver diamine fluoride
Trials testing the same drug.
- NCT07431463 — Effects of Different Remineralization Agents on the Progression of Non-Cavitated Approximal Carious Lesions in Primary T · NA · active not recruiting
- NCT06092151 — SDF for the Management of Dental Caries in Children in Primary Dental Care: Protocol for a Feasibility Study · NA · unknown
- NCT05255913 — Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries · NA · completed
- NCT05221749 — The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth · Phase 3 · terminated
- NCT04889196 — The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars · Phase 3 · unknown
Other recruiting trials for Early Childhood Caries
Currently open trials in the same condition.
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- NCT06441500 — Oral Health and Dental Caries Prevention Intervention for Children in Romania · NA · recruiting
- NCT06241261 — Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel · Phase 2 · active not recruiting
- NCT05716867 — Salivary Cystatin S Levels in a Group of Egyptian Children · active not recruiting
Other Universiti Teknologi Mara trials
Trials by the same sponsor.
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- NCT07134010 — The Impact of Perineural Injection Therapy for Adhesive Capsulitis. · NA · recruiting
- NCT07402967 — Perceptions of Parents and Children on Posterior Restorations in Primary Molars · completed
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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 NCT06316323 (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 Universiti Teknologi Mara
- Last refreshed: 18 March 2024
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