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

NCT06699199 | Recruiting Phase 4 DMC

• 2 other identifiers: 139-07-23Research center
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dental Management; Oral Microbiome; Caries Arrest; SDF; Silver diamine fluoride 38%; Potassium iodide

Outcome Measures

Primary Outcomes (1)

• Arresting Effect

  Arresting conditions (Arresting rate) will be assessed through clinical examination and intra-oral Photos evaluation of the cavities before and 2-4 weeks after SDF treatments * Caries activity status will be recorded as (active;1 or arrested;2) according to hardness and color (Caries activity status scored as 1: active or 2: arrested * Descriptive definition : * 1:Active lesion: tooth surface is deemed active if any softened area on the carious lesion is detected upon probing or no obvious changes in color, and the lesion is still soft. * 2:Arrested lesion: When the entire carious lesion is determined to be hard upon probing, or lesion is Darker in color and has hard surfaces (harder to excavate with a spoon excavator), it will be recorded as arrested caries.

  Baseline and follow up (after 2-4 weeks)

Secondary Outcomes (1)

• Microbial status

  Baseline and follow up (after 2-4 weeks)

Other Outcomes (1)

• Adverse events

  Baseline and follow up (after 2-4 weeks)

Study Arms (2)

Arresting Treatment 1

ACTIVE COMPARATOR

Management of dental caries in children between the ages of 4 and 10 by arresting the lesion using standard Treatment for caries arrest, which is silver diamine fluoride %38

Drug: Silver diamine Fluoride 38%

Arresting Treatment 2

EXPERIMENTAL

Management of dental caries n children between the ages of 4 and 10 by arresting the lesion using an alternative Treatment by using the combination of Silver diamine fluoride 38% + potassium iodide (SDF+KI), Both products reported as materials with an anti-microbial effect

Drug: Silver diamine fluoride- potassium iodide

Interventions

Silver diamine Fluoride 38% DRUG

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%.

Also known as: E-SDF, Silver diamine fluoride

Arresting Treatment 1

Silver diamine fluoride- potassium iodide DRUG

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)

Also known as: Silver diamine fluoride 38% + potassium iodide, Riva- star SDF

Arresting Treatment 2

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy patients.
• Patients within 4-10 years of age.
• The presence of at least one deciduous tooth with a caries lesion that is directly accessible (cavitates)

You may not qualify if:

• Presentation of irreversible pulpititis or necrosis• The extensive lesion was restored.
• The surface of the lesion was hard and smooth.
• Children with inherited or systemic conditions.
• Children with a substantial medication history or those who have taken antibiotics within the previous three months.
• Children who have undergone topical fluoride treatment within the previous 2 weeks.

Sponsors & Collaborators

• King Abdulaziz University: lead
• King Fahd Medical Research Centre: collaborator

Study Sites (1)

University Dental hospital of King Abdulaziz University

Jeddah, Mecca Region, 80209, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride; Potassium Iodide

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Iodides; Iodine Compounds; Inorganic Chemicals; Potassium Compounds

Study Officials

• Dr. Turki S Abujamel, BDS, MSc, PhD

  Department of Medical Laboratory Science, King Abdulaziz University and KFMRC Deputy Director of Administrative and Financial Affairs.

  STUDY DIRECTOR

• Prof. (Dr.) Abdullah S AlMushayt, BDS, MSc, PhD

  Faculty of Dentistry, Department of Pediatric Dentistry, King Abdulaziz University Jeddah, Saudi Arabia

  STUDY DIRECTOR

• Nada O Bamashmous, BDS, MSc, DDENT

  Faculty of Dentistry, Department of Pediatric Dentistry, King Abdulaziz University Jeddah, Saudi Arabia

  STUDY DIRECTOR

• Shatha O Bamashmous, BDS, MSc, PhD

  Department of Periodontology, KAU Faculty of Dentistry, Jeddah, Saudi Arabia

  STUDY DIRECTOR

Central Study Contacts

Dr.Doaa Y Jamal, BDS, MSc, SBPD

CONTACT

(+966)-558887632; Djamal0004@stu.kau.edu.sa

Prof. (Dr.) Abdullah S AlMushayt, BDS, MSc, PhD

CONTACT

(+966)-507733313; aalmushayt@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate - Pediatric dental specialist

Model Details: Children will receive one of two interventions 1. Silver diamine fluoride 38% (SDF only) or, 2. Silver diamine fluoride 38% + potassium iodide (SDF +KI) Both treatment are recommend and approved as an arresting treatment of Dental caries in children as an intermediate management

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 21, 2024
• Study Start: November 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 6, 2025

Record last verified: 2024-11

Locations

SA (1)