Using silver diamine fluoride to treat dental caries in children
Clinical Effectiveness of Silver Diamine Fluoride on Arresting Caries Lesions in Children
This study tests if using silver diamine fluoride can help treat cavities in preschool children without the need for more invasive dental work.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 7 Years |
| Sex | All |
| Sponsor | Umm Al-Qura University Academic / other |
| Locations | 1 site (Mecca) |
| Trial ID | NCT05872542 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of silver diamine fluoride (SDF) in controlling asymptomatic cavitated carious lesions in preschool children compared to traditional glass ionomer restoration. The research aims to minimize invasive procedures and reduce stress for young patients by utilizing a non-invasive treatment approach. SDF works through chemical reactions that promote the arrest of carious lesions, leveraging the bactericidal properties of silver ions and the remineralizing effects of fluoride. The study will assess the clinical outcomes of SDF application in a pediatric dental setting.
Who should consider this trial
Good fit: Ideal candidates are healthy preschool children with at least one untreated asymptomatic cavitated carious lesion affecting primary molars.
Not a fit: Patients with allergies to silver compounds or those who refuse SDF treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive and more effective option for managing dental caries in children.
How similar studies have performed: Previous studies have shown promising results with SDF in arresting dental caries, indicating that this approach is gaining acceptance in pediatric dentistry.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy children without a history of serious systemic conditions necessitating chronic use of medications. * Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS index: code 3-5) affecting primary molars. * Absence of former history of spontaneous pain from the offending tooth/teeth. * Teeth with normal vital pulp response when assessed using sensibility test and absence of any signs of irreversible pulpitis or necrotic pulp degeneration. * Absence of abnormal grade of tooth mobility, swelling, or tenderness on palpation or percussion. * Absence of any evidence of peri-radicular pathosis, or internal- or external resorption on radiographic examination. Exclusion Criteria: * Patients with proven allergy to silver compounds or any component of dental materials to be applied. * Patients or guardians who refuse to participate in the study or had poor acceptance of SDF treatment. * Patients with ulcerative gingivitis or stomatitis.
Where this trial is running
Mecca
- UmmAlQuraUniversity — Mecca, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Abla Arafa — Assistant Professor
- Study coordinator: Abla Arafa
- Email: ablaarafa@hotmail.com
- Phone: +966543869336
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.