Evaluating a dental treatment for deep carious lesions in children's molars

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Canakkale Onsekiz Mart University
  Çanakkale, Kepez, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: HİLAL ÖZTÜRK Research Assistant
• Email: hilalozturk98@gmail.com
• Phone: 00905312591404

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.