Clinical and Cost-Effectiveness of Silver Diamine Fluoride and Silver Fluoride, With or Without Application of LED, in Arresting Incipient Permament Molar Caries (SDF and AgF)

January 16, 2026 updated by: Alaa Amr Khodair, Cairo University

Clinical Efficacy and Cost-Effectiveness of Silver Diamine Fluoride and Silver Fluoride to Arrest Incipient Carious Lesions in Permanent Molar Teeth With or Without Application of LED Light: A Randomized Clinical Trial

The study aims to compare the effect of international brand ammonia based 38% SDF, water based silver fluoride solution (AgF), an aqueous silver fluoride solution, and local brand ammonia based SDF with and without LED light application on caries arrest of initial enamel pits and fissure caries for permanent teeth of young adults

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

366

Phase

  • Not Applicable

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • high caries risk dental students
  • Males or females
  • Medically free
  • Not taking medication
  • At least had one active carious tooth
  • Posterior permanent teeth
  • ICDAS 2

Exclusion Criteria:

  • non-Egyptian students
  • Lack of compliance
  • Allergic reaction to the materials used
  • Pregnancy
  • Dental students cannot give consent
  • Teeth that will be extracted for orthodontic reasons
  • Dental fluorosis
  • Hypo calcified teeth
  • Systemic diseases affecting teeth, such as amelogenesis imperfecta
  • Severe periodontal affection

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pits and fissures receive International Silver Diamine Fluoride for caries arrest
Remineralization and prevention of incipient pits and fissure caries of permanent molars by International Silver Diamine Fluoride application for 60 seconds
Other: International Sliver Diamine Fluoride
It is the gold standard; it is an international brand, it is ammonia-based, and it is a remineralizing agent with an application time of 60 seconds.
Experimental: Pits and fissures receive Local brand Egyptian Sliver Diamine Fluoride for caries arrest
Remineralization and prevention of incipient pits and fissure caries of permanent molars by local brand Egyptian Silver Diamine Fluoride application for 60 seconds
Other: Local brand Egyptian Silver Diamine Fluoride
It is a new Egyptian brand of SDF; it is ammonia-based, and it is a remineralizing agent with an application time of 60 seconds.
Experimental: Pits and fissures receive Sliver Fluoride for caries arrest
Remineralization and prevention of incipient pits and fissure caries of permanent molars by Silver Fluoride application for 60 seconds
Other: Silver Fluoride
It is a water-based remineralizing agent with an application time of 60 seconds.
Experimental: Pits and fissures receive International Silver Diamine Fluoride with LED for caries arrest
Remineralization and prevention of incipient pits and fissure caries of permanent molars by Silver Diamine Fluoride application for 10 seconds, followed by the application LED light for 20 seconds
Other: International Sliver Diamine Fluoride with LED light
It is an international brand, it is ammonia-based, and it is a remineralizing agent with an application time of 10 seconds, followed by LED light application for 20 seconds.
Experimental: Pits and fissures receive local brand Egyptian Silver Diamine Fluoride with LED for caries arrest
Remineralization and prevention of incipient pits and fissure caries of permanent molars by local brand Egyptian Silver Diamine Fluoride application for 10 seconds, followed by LED light for 20 seconds
Other: Local brand Egyptian Silver Diamine Fluoride with LED light
It is a new Egyptian brand of SDF; it is ammonia-based, and it is a remineralizing agent with an application time of 10 seconds, followed by LED application for 20 seconds.
Experimental: Pits and fissures receive Sliver Fluoride with LED for caries arrest
Remineralization and prevention of incipient pits and fissure caries of permanent molars by Silver Fluoride application for 10 seconds, followed by application of LED light for 20 seconds
Other: Silver Fluoride with LED light
It is a water-based remineralizing agent with an application time of 10 seconds, followed by LED light application for 20 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries arrest
Time Frame: After 3, 6, and 12 months.
Lesion activity will be assessed by caries status (active/inactive) using visual and tactile inspection for surface discontinuities and texture. The participants will be examined under unit light using a 0.5 mm ball-ended (CPI) probe and a dental mirror. The teeth will be cleaned and dried by a water-air spray syringe before the examination.
After 3, 6, and 12 months.

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 (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3344515

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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