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

May 7, 2026 updated by: Mariam Mohsen Aly, Cairo University

Evaluation of the Long-term Effect of Silver Diamine Fluoride on the Dentin-Pulp Complex in Primary Teeth: A Histological Study

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Dentistry, Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • Treated primary teeth with clinical or radiographic signs of infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Arm 1
Children treated with Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer
Arm 2
Children treated with Resin Modified Glass Ionomer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological evaluation of dental pulp under light microscope
Time Frame: 7 days after extraction
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

May 7, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SDF histological evaluation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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