Silver Diamine Flouride in Arresting Enamel Caries

NCT07125937 | Completed DMC

• 1 other identifier: Dr Kinza
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carious Lesion

Outcome Measures

Primary Outcomes (1)

• Proportion of enamel caries lesions arrested after SDF application

  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

  3 months post-intervention

Study Arms (1)

38% Silver Diamine Fluoride Application

EXPERIMENTAL

Participants will receive a single application of 38% Silver Diamine Fluoride (Advantage Arrest™, Elevate Oral Care LLC) on enamel caries lesions (ICDAS scores 1-3) in molars and premolars, following the UCSF protocol. Lesions will be evaluated clinically (ICDAS) and radiographically (ICCMS) at 3 weeks and 3 months post-treatment to assess caries arrest.

Drug: 38% Silver Diamine Fluoride

Interventions

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.

38% Silver Diamine Fluoride Application

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age group of subjects between 18 - 50 years
• Carious lesions with ICDAS score 1, 2 and 3 in molars and premolars

You may not qualify if:

• PDL widening with periapical radiolucency around molars and premolars
• Premolars and Molars with any white lesions other than caries
• Third molars

Sponsors & Collaborators

• HITEC-Institute of Medical Sciences: lead

Study Sites (1)

Hitec Ims

Rawalpindi, Punjab Province, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dr Kinza Iftikhar, BDS

  HITEC-Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kinza Iftikhar

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 15, 2025
• Study Start: May 7, 2024
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)