Evaluating a dental treatment for deep carious lesions in children's molars
Silver Modified Atraumatic Restorative Technique (SMART) With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.
This study is testing if a new way of treating deep cavities in kids' back teeth works better than the standard method to help improve their dental health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 4 Years to 9 Years |
| Sex | All |
| Sponsor | Çanakkale Onsekiz Mart University Academic / other |
| Locations | 1 site (Çanakkale, Kepez) |
| Trial ID | NCT06645860 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical success of the Silver Modified Atraumatic Restorative Technique (SMART) with various modifications for treating asymptomatic deep carious lesions in primary molars of children aged 4-9. The SMART technique combines Silver Diamine Fluoride (SDF) with atraumatic restorative methods to manage dental caries effectively. Participants will be randomly assigned to receive either the standard SMART treatment or an enhanced version using LED light to assess the effectiveness of these approaches in restoring dental health.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 4-9 with asymptomatic cavitated carious lesions in their primary molars.
Not a fit: Patients with allergies to silver compounds or those with serious systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a minimally invasive and effective solution for managing dental caries in young children.
How similar studies have performed: Similar approaches using SDF have shown promise in managing dental caries, indicating potential success for this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients and parents of the patients who accept to participate and sign the informed consent. 2. Children between the ages of 4-9 3. Healthy children without a history of serious systemic conditions necessitating chronic use of medications. 4. Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS II index: code 4,5,6) affecting primary molars. 5. Absence of former history of spontaneous pain from the offending tooth/teeth. 6. Patients with an appropriate level of cooperation to complete treatment under clinical conditions. 7. Teeth are in a restorable condition. 8. Natural exfoliation of primary teeth to be treated should not be expected within two years. Exclusion Criteria: 1. Patients and parents of the patients who does not accept to participate and sign the informed consent 2. Patients with proven allergy to silver compounds or any component of dental materials to be applied. 3. Patients with special health care needs or any medical conditions. 4. Primary molar teeth with excessive crown damage that cannot be restored. 5. Primary molar teeth in which bone loss exceeds 1/3 of the roots. 6. Primary molar teeth that have previously undergone root canal treatment or pulpotomy treatment. 7. Presence of internal/external and root resorption in primary teeth to be treated. 8. Root fracture, ankylosis or mobility in the primary teeth to be treated.
Where this trial is running
Çanakkale, Kepez
- Canakkale Onsekiz Mart University — Çanakkale, Kepez, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: HİLAL ÖZTÜRK Research Assistant
- Email: hilalozturk98@gmail.com
- Phone: 00905312591404
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.