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

NCT07708883 | Active Not Recruiting

• 1 other identifier: 0341
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

dental caries; SDF; Silver Diamine fluoride; caries arrest

Outcome Measures

Primary Outcomes (1)

• number of tooth with arrested caries in each group

  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

Study Arms (2)

SDF, ToothMate®, Egypt.

EXPERIMENTAL

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; Other: SDF, Advantage Arrest USA

SDF, Advantage arrest®, USA

ACTIVE COMPARATOR

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; Other: SDF, Advantage Arrest USA

Interventions

SDF, ToothMate®, Egypt OTHER

38% silver diamine fluoride manufactured in Egypt

SDF, Advantage arrest®, USA; SDF, ToothMate®, Egypt.

SDF, Advantage Arrest USA OTHER

38% silver diamine fluoride , manufactured in USA

SDF, Advantage arrest®, USA; SDF, ToothMate®, Egypt.

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Cairo, Cairo Governorate, 12572, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher of Pediatric Dentistry

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: October 4, 2025
• Primary Completion (Estimated): October 4, 2026
• Study Completion (Estimated): October 4, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)