Silver Diamine Flouride in Arresting Enamel Caries

This interventional study aims to evaluate the effectiveness of 38% Silver Diamine Fluoride (SDF) in arresting enamel caries in adults aged 18-50 years. Dental caries is a biofilm-mediated, multifactorial disease that can cause progressive tooth damage. Conventional treatments are invasive and costly, whereas SDF offers a non-invasive, low-cost alternative. A total of 250 patients meeting the inclusion criteria will be treated with SDF following the UCSF protocol. Lesions will be evaluated clinically using ICDAS and radiographically using ICCMS at 3 weeks and 3 months post-intervention. The primary outcome is the proportion of enamel caries lesions arrested after treatment. Data will be analyzed using the chi-square test.

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Key information

Conditions

Carious Lesion Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hitec Ims

Rawalpindi, Punjab Province, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age group of subjects between 18 - 50 years

Carious lesions with ICDAS score 1, 2 and 3 in molars and premolars

Exclusion criteria

PDL widening with periapical radiolucency around molars and premolars

Premolars and Molars with any white lesions other than caries

Third molars

Treatment and study plan

38% silver diamine fluoride

Drug

A topical ammonia solution containing silver and fluoride ions applied directly to enamel caries lesions. Application will follow the UCSF protocol: lesions will be cleaned, isolated, and treated with SDF for 2 minutes using a microbrush applicator.

Primary outcomes

Proportion of enamel caries lesions arrested after SDF application

Time frame: 3 months post-intervention

Lesions will be clinically evaluated using the International Caries Detection and Assessment System (ICDAS) and radiographically using the International Caries Classification and Management System (ICCMS). Arrest is defined as no progression in ICDAS score and no radiographic progression

Sponsors and collaborators

Lead sponsor

HITEC-Institute of Medical Sciences

Other

Registry information

Official study title

ROLE OF SILVER DIAMINE FLUORIDE (SDF) IN ARRESTING ENAMEL CARIES IN ADULTS REPORTING TO DENTAL COLLEGE HITEC-IMS TAXILA

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 15, 2025
Registry last updated: Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed