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

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)

Conditions

• Dental Caries

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)

Sponsors & Collaborators

• King Fahd Medical Research Centre

  collaborator OTHER

• King Abdulaziz University

  lead OTHER

Principal Investigators

• Dr. Turki S Abujamel, BDS, MSc, PhD · Department of Medical Laboratory Science, King Abdulaziz University and KFMRC Deputy Director of Administrative and Financial Affairs.

• Prof. (Dr.) Abdullah S AlMushayt, BDS, MSc, PhD · Faculty of Dentistry, Department of Pediatric Dentistry, King Abdulaziz University Jeddah, Saudi Arabia

• Nada O Bamashmous, BDS, MSc, DDENT · Faculty of Dentistry, Department of Pediatric Dentistry, King Abdulaziz University Jeddah, Saudi Arabia

• Shatha O Bamashmous, BDS, MSc, PhD · Department of Periodontology, KAU Faculty of Dentistry, Jeddah, Saudi Arabia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-01

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• Saudi Arabia

Study Locations