Efficacy of Silver Diamine Fluoride Compared to Fluoride Varnish for Arresting Non-cavitated Lesions on Approximal Surfaces in Permanent Premolars and Molars: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210706004

Enrollment

Registered

2021-07-06

Start date

2021-07-12

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, coexist together in biofilm or plaque, is the key contributor silver diamine fluoride, fluoride varnish, noncavitated lesion, approximal surface, caries arresting rate

Interventions

1.Soft tissues will be protected with petroleum jelly to avoid staining and mucosal irritation, as recommended by the manufacturer. 2.Moisture will be controlled by using cotton rolls and saliva eject

Active Comparator Drug,Active Comparator Drug

Silver diamine fluoride,Sodium fluoride varnish

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Children aged 6-18 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 permanent premolars and molars 3.Presence of at least one active initial caries lesion (ICDAS score 1 or 2 or 3) on approximal surfaces in permanent premolars and 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

Measure	Time frame
Caries arresting rate 1 year Clinical examination and radiographic examination	—

Secondary

Measure	Time 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