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NCT Number: NCT07708883

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre

Cairo, Cairo Governorate, 12572, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SDF, ToothMate®, Egypt

Other

38% silver diamine fluoride manufactured in Egypt

SDF, Advantage Arrest USA

Other

38% silver diamine fluoride , manufactured in USA

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Registry information

Official study title

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

Acronym: SDF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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