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

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: Dental Caries
• Intervention / Treatment: Other: SDF, ToothMate®, Egypt; Other: SDF, Advantage Arrest USA

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Children who are apparently healthy with primary carious teeth aged from 4-7 years.

  2. Uncooperative children. 3. Children with financial barrier in accessing dental care 4. Clinically: absence of any pathology or pain except of sensitivity with eating.

  5. Parents and patients accepting the new treatment modality and parents assigned the informed consent.

Exclusion Criteria:

• 1. Known sensitivity to silver or other heavy-metal ions. 2. Children who will not comply to recall program. 3. Teeth with pulp involvement. 4. Tooth mobility (more than grade 1 (grade 1:1-2 mm tooth mobility). 5. History of pain for a long period of time that may indicate chronic pulp inflammation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SDF, ToothMate®, Egypt.; Egyptian manufactured SDF, 38% silver diamine fluoride is applied. Before application of toothmate 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	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. 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	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
o Arrest of caries	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

• Sponsor: National Research Centre, Egypt

Study record dates

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 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: caries arrest; dental caries; SDF; Silver Diamine fluoride
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• 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