CClinicalTrials.gg
Active, not recruitingNCT07708883SDFUpdated Jul 28, 2026

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

An interventional study of SDF, ToothMate®, Egypt and SDF, Advantage Arrest USA in Dental Caries, sponsored by National Research Centre, Egypt. Active, not recruiting at 1 site in Egypt. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by National Research Centre, Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Oct 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Caries

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Keywords

  • dental caries
  • SDF
  • Silver Diamine fluoride
  • caries arrest
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 134 is above the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

National Research Centre, Egypt is the lead sponsor of 49 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
134 participants (actual)

Study arms

  • 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 · Other: SDF, Advantage Arrest 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 · Other: SDF, Advantage Arrest USA

Interventions

  • OtherSDF, ToothMate®, Egypt

    38% silver diamine fluoride manufactured in Egypt

  • OtherSDF, Advantage Arrest USA

    38% silver diamine fluoride , manufactured in USA

06

What researchers measure

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)

    Time frame: 12 months

07

Study locations

1 site
  • National Research Centre
    Cairo, Cairo Governorate 12572, Egypt
08

References and documents

Study documents

  • Study protocol · Oct 4, 2025
  • Informed consent form · Oct 4, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07708883
Lead sponsor
National Research Centre, Egypt
Responsible party
Rabab Mahmoud Abd Elhakam (Researcher of Pediatric Dentistry, National Research Centre, Egypt) — Principal investigator
First posted
Jul 16, 2026
Start date
Oct 4, 2025
Primary completion
Oct 4, 2026 (estimated)
Completion
Oct 4, 2026 (estimated)
Last update
Jul 28, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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