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Efficacy of silver diamine fluoride compared to fluoride varnish for arresting non-cavitated lesions on approximal surfaces: a randomized controlled trial

Efficacy of silver diamine fluoride compared to fluoride varnish for arresting non-cavitated lesions on approximal surfaces: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200917001
Enrollment
60
Registered
2020-09-17
Start date
2020-09-26
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries is a chronic infectious disease caused by imbalance between demineralization and remineralization. The cariogenic bacteria&#44

Interventions

1.Soft tissues will be protected with petroleum jelly to avoid staining and mucosal irritation&#44
as recommended by the manufacturer. 2.Moisture will be controlled by using cotton rolls and saliva ejectors. 3.Fresh pressed of 38% SDF (Topamine®&#44
PharmaDesign Co.&#44
Australia) will be used to apply on lesions with a small disposable micro brush for 1 min&#44
removed excess with gauze. (Figure 4) 4.Patients are advised to avoid eating and drinking for 30 minutes. ,1.After cleaning teeth and evaluating caries status&#44
lesions will be controlled moisture by using a cotton rolls or gauze and high&#45
powered suction. 2.Apply fluoride varnish directly to the lesions with gingival brush. 3.Patients are advised to avoid eating hard food for 2 hours and brush their teeth in the next day.
Active Comparator Drug,Active Comparator Drug

Sponsors

Faculty of Dentistry, Chiang Mai University
Lead Sponsor
Faculty of Dentistry&#44
Collaborator
Chiang Mai University
Collaborator

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Children aged 3-12 years 2.Presence of at least one initial stage of approximal caries lesion (radiographic score RA1 or RA2 or RA3), detected by bitewing radiographs, on approximal surfaces in primary molars 3.Presence of at least one active initial caries lesion (ICDAS score 1 or 2 or 3) on approximal surfaces in primary molars, detected by visual and tactile examination. For this purpose, surfaces will be evaluated after tooth separation for at least 48 hours. After orthodontic rubber removal, approximal surfaces will be assessed directly using visual and tactile examination. All surfaces eligible for this study will be included. 4.Normal tooth alignment

Exclusion criteria

Exclusion criteria: 1.Children with systemic conditions 2.Allergic to silver or colophony base or any component of the test products 3.Children or adolescents who refuse to participate in the study or present negative behaviors. 4.Previously restorative teeth (on that lesion) 5.Molar-Incisor Hypomineralization teeth (MIH) 6.Enamel hypoplasia

Design outcomes

Primary

MeasureTime frame
Caries arresting rate 1 year Clinical examination and radiographic examination

Secondary

MeasureTime frame
Patient's and Parental acceptance 1 year questionaire

Countries

Thailand

Contacts

Public ContactOnnida Wattanarat

Faculty of Dentistry, Chiang Mai University

onni076@gmail.com66849857634

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026