Silver Diamine Flouride in Arresting Enamel Caries

NCT ID: NCT07125937

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-07

Study Completion Date

2025-05-07

Brief Summary

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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.

Detailed Description

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Conditions

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Carious Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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38% Silver Diamine Fluoride Application

Participants will receive a single application of 38% Silver Diamine Fluoride (Advantage Arrestâ„¢, 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.

Group Type EXPERIMENTAL

38% Silver Diamine Fluoride

Intervention Type 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.

Interventions

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38% Silver Diamine Fluoride

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HITEC-Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr Kinza Iftikhar

Kinza Iftikhar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Kinza Iftikhar, BDS

Role: PRINCIPAL_INVESTIGATOR

HITEC-Institute of Medical Sciences

Locations

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Hitec Ims

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Related Links

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Other Identifiers

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Dr Kinza

Identifier Type: -

Identifier Source: org_study_id

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