Long-term Effect of Silver Diamine Fluoride on the Dentin-Pulp Complex in Primary Teeth

NCT07586631 | Recruiting

• 1 other identifier: SDF histological evaluation
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Children with primary teeth with dentin carious lesions without pulp involvement, who have previously been treated with either Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer or with Resin Modified Glass Ionomer alone, will be retrieved from the Pediatric Dentistry and Dental Public Health Department records. The aim of the study, a detailed description of the procedure, and how the tooth will be used, will be explained to the parents and their child, and written informed consent from the parents and assent from the child will be obtained.

Conditions

Silver Diamine Fluoride

Outcome Measures

Primary Outcomes (1)

• Histological evaluation of dental pulp under light microscope

  After teeth extraction, they will be fixed in a 10% formalin buffer for at least 48 hours, after which they will be decalcified in 10% nitric acid for 7 days. Then they will be embedded in paraffin, and mesiodistal histological sections approximately 8 μm thick will be cut. Sections will be stained with hematoxylin and Eosin, and a qualitative histological evaluation of dental pulp will be performed under light microscopy.

  7 days after extraction

Study Arms (2)

Arm 1

Children treated with Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer

Arm 2

Children treated with Resin Modified Glass Ionomer

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with primary teeth that have previously been treated with either Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer or Resin Modified Glass Ionomer alone.

You may qualify if:

• \- Primary teeth that have previously been treated with either Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer or Resin Modified Glass Ionomer alone.

You may not qualify if:

• Treated primary teeth with clinical or radiographic signs of infection

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Pediatric Dentistry and Dental Public Health

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 14, 2026
• Study Start: January 29, 2026
• Primary Completion: May 7, 2026
• Study Completion: May 15, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

EG (1)