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RECRUITING
NCT06699199
PHASE4

Effect of Silver Diamine Fluoride Application on Oral Microbiome of Healthy Pediatric Patient

Sponsor: King Abdulaziz University

View on ClinicalTrials.gov

Summary

This clinical trial aims to learn more about the working mechanism of an antimicrobial agent used to manage dental caries, especially in young, uncooperative children. It will also provide a deeper insight into different products of the same agent and its effectiveness in Arresting dental caries. The main questions it aims to answer are: What is the clinical impact of silver diamine fluoride application in caries-active children? What is the antimicrobial effect of silver diamine fluoride in oral microbial inhabitants? Researchers will compare silver diamine fluoride (SDF)only and silver diamine fluoride+ potassium iodide(SDF+KI) to see which materials substantially affect on dental caries and oral microbial inhabitants Participants/Parent will: The parent will fill out a comprehensive data sheet for the child (childhood and current dental and medical history) Visit the dental clinic to Receive one of 2 (SDF or SDF+KI) treatment applications once Visit the clinic a 2nd time for a 2-4 week Treatment Follow-up Go through the sample collection process twice( pre- and 2-4 weeks post- Treatment) Sample collection including (Saliva- Biofilm and caries tissue sample)

Official title: Effect of Silver Diamine Fluoride Application on Oral Microbiome of Saudi Children: Randomized Clinical Trial in Jeddah City

Key Details

Gender

All

Age Range

4 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-11-01

Completion Date

2025-06-30

Last Updated

2025-03-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

Silver diamine Fluoride 38%

Intervention is the application of Silver diamine fluoride 38% to children Group in arm 1 (Arm 1): children will receive Silver diamine fluoride 38% application for 1 min to arrest primary teeth SDF: (Silver diamine fluoride 38% is a material used for arresting caries lesions in primary and permanent teeth) \- SDF Product generic name and information (E-SDF: it is a 1-step Technique) - The 38% SDF solution comprised a blend of silver, fluoride, and ammonia at a total concentration of 38%.

DRUG

Silver diamine fluoride- potassium iodide

Intervention is the application of Silver diamine fluoride 38% + potassium iodide to children Group in arm 2 (Arm 2): children will receive Silver diamine fluoride 38% application for 1 min to arrest primary teeth, Followed by an second minute of potassium iodide solution application \- SDF Product generic name and information (Riva-star: it is a 2-step Technique) 30-35% SDF solution (1st step) comprised a blend of silver, fluoride, and ammonia applied in combination with a second application of potassium iodide solution (2nd step)

Locations (1)

University Dental hospital of King Abdulaziz University

Jeddah, Mecca Region, Saudi Arabia