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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07708883
Acronym
SDF
Enrollment
134
Registered
2026-07-16
Start date
2025-10-04
Completion date
2026-10-04
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

dental caries, SDF, Silver Diamine fluoride, caries arrest

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.

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.

Interventions

OTHERSDF, ToothMate®, Egypt

38% silver diamine fluoride manufactured in Egypt

OTHERSDF, Advantage Arrest USA

38% silver diamine fluoride , manufactured in USA

Sponsors

National Research Centre, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
number of tooth with arrested caries in each group12 monthsArrest of caries through: * tactile examination to assess hardness of treated lesions using gentle pressure with a probe, * color examination (yellow, brown or black)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026