Effect of Silver Diamine Fluoride Application on Oral Microbiome of Healthy Pediatric Patient
Effect of Silver Diamine Fluoride Application on Oral Microbiome of Saudi Children: Randomized Clinical Trial in Jeddah City
King Abdulaziz University
50 participants
Nov 1, 2023
INTERVENTIONAL
Conditions
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)
Eligibility
Inclusion Criteria3
- 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)
Exclusion Criteria5
- 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.
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Interventions
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%.
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)
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NCT06699199