Effect of Silver Diamine Fluoride Application on Oral Microbiome of Healthy Pediatric Patient
ConditionDental Caries
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4-12
SponsorKing Abdulaziz University
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Silver diamine Fluoride 38%
DrugIntervention 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%.
Silver diamine fluoride- potassium iodide
DrugIntervention 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)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Arresting Treatment 1Active comparator 1 intervention
Group B: Arresting Treatment 2Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and follow up (after 2-4 weeks)Secondary outcomes
1
Microbial status
Change in oral Microbial inhabits using sequencing techniques of the oral Microbiome. Microbial DNA will be extracted and sequenced using 16S rRNA gene amplicon-based and shotgun metagenomic sequences. Data will be presented as 1. Changes of microbial taxonomic profiles and microbial diversity within the same group (SDF group or SDF+KI group) 2. Difference in microbial taxonomic profiles and microbial diversity between interventions groups after assigned treatment application, differences between groups (SDF group and SDF+KI group)
Time frame
Baseline and follow up (after 2-4 weeks)Other outcomes
1
Adverse events
Any reported outcome by the child or parents of the following; (by answering a yes or no questions in a follow up visit short interview based questionnaire) * Pain/ sensitivity: (Yes or No) * Discoloration/stains other areas (Extra- Intra):(Yes or No) * Metallic taste: (Yes or No) * Gingival lesions: (Yes or No) * Pulp or abscess: (Yes or No)
Time frame
Baseline and follow up (after 2-4 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
King Abdulaziz University
Lead sponsor
King Fahd Medical Research Centre
Collaborator
Source ClinicalTrials.gov