Effect of Silver Diamine Fluoride on Oral Microbiome in Children
Effect of Silver Diamine Fluoride Application on Oral Microbiome of Saudi Children: Randomized Clinical Trial in Jeddah City
PHASE4 · King Abdulaziz University · NCT06699199
This study is testing whether silver diamine fluoride alone or with potassium iodide can help stop cavities in healthy children aged 4-10 and how these treatments affect the germs in their mouths.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | King Abdulaziz University (other) |
| Locations | 1 site (Jeddah, Mecca Region) |
| Trial ID | NCT06699199 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of silver diamine fluoride (SDF) and a combination of SDF with potassium iodide (SDF+KI) on dental caries in healthy children aged 4-10. The study aims to evaluate the effectiveness of these treatments in arresting caries and their effects on the oral microbiome. Participants will receive one of the two treatments and return for follow-up assessments to analyze changes in saliva composition and microbial inhabitants. The research is conducted at King Abdulaziz University with informed consent from parents.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 4-10 with at least one accessible carious deciduous tooth.
Not a fit: Patients with irreversible pulpitis, extensive restorations, or significant systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective non-invasive treatment option for managing dental caries in young children.
How similar studies have performed: Other studies have shown promising results with silver diamine fluoride in caries management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * 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 Criteria: * 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.
Where this trial is running
Jeddah, Mecca Region
- University Dental hospital of King Abdulaziz University — Jeddah, Mecca Region, Saudi Arabia (RECRUITING)
Study contacts
- Study coordinator: Dr.Doaa Y Jamal, BDS, MSc, SBPD
- Email: Djamal0004@stu.kau.edu.sa
- Phone: (+966)-558887632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Caries, Dental Management, Oral Microbiome, Caries Arrest, SDF, Silver diamine fluoride 38%, Potassium iodide