Comparing Two Brands of Silver Diamine Fluoride for Stopping Cavities in Children (SDF)

July 26, 2026 updated by: Rabab Mahmoud Abd Elhakam, National Research Centre, Egypt

Comparative Study of Two Different Marketed Brands of Silver Diamine Fluoride SDF in Arresting Dental Caries in Children (Randomized Control Trial)

this study aims to evaluate two different materials used to stop dental caries in children. both materials are available at the market. both materials leave black stain after application. we follow up the patients for 1 year to evaluate which one is more effective in stopping dental caries.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Before application of SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. SDF in both groups will be applied directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.

All children will be recalled after 6 and 12 months for follow up.

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 12572
        • National Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children who are apparently healthy with primary carious teeth aged from 4-7 years.
  • Uncooperative children.
  • Children with financial barrier in accessing dental care
  • Clinically: absence of any pathology or pain except of sensitivity with eating.
  • Parents and patients accepting the new treatment modality and parents assigned the informed consent.

Exclusion Criteria:

  • Known sensitivity to silver or other heavy-metal ions.
  • Children who will not comply to recall program.
  • Teeth with pulp involvement.
  • Tooth mobility (more than grade 1 (grade 1:1-2 mm tooth mobility).
  • History of pain for a long period of time that may indicate chronic pulp inflammation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SDF, ToothMate®, Egypt.

Egyptian manufactured SDF, 38% silver diamine fluoride is applied. Before application of tooth mate SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Tooth mate SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.

All children will be recalled after 6 and 12 months for follow up
Other: SDF, ToothMate®, Egypt
38% silver diamine fluoride manufactured in Egypt
Other: SDF, Advantage Arrest USA
38% silver diamine fluoride , manufactured in USA
Active Comparator: SDF, Advantage arrest®, USA

USA manufactured SDF, 38% silver diamine fluoride. Before application of Advantage arrest SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Advantage arrest SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.

All children will be recalled after 6 and 12 months for follow up
Other: SDF, ToothMate®, Egypt
38% silver diamine fluoride manufactured in Egypt
Other: SDF, Advantage Arrest USA
38% silver diamine fluoride , manufactured in USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of tooth with arrested caries in each group
Time Frame: 12 months

Arrest of caries through:

  • tactile examination to assess hardness of treated lesions using gentle pressure with a probe,
  • color examination (yellow, brown or black)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Centre, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2025

Primary Completion (Estimated)

October 4, 2026

Study Completion (Estimated)

October 4, 2026

Study Registration Dates

First Submitted

July 12, 2026

First Submitted That Met QC Criteria

July 12, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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