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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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