Comparing two techniques for treating cavities in children's back teeth

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 clinical trial aims to compare the treatment outcomes of the SMART Hall technique and conventional stainless steel crown (SSC) restoration for managing carious lesions in primary molars of children aged 3 to 9 years. The study will evaluate clinical success rates, treatment duration, survival rates, radiographical outcomes, and patient-reported perceptions over a follow-up period of 3 and 6 months. The SMART Hall technique emphasizes minimal tooth reduction and aims to improve patient comfort and cooperation compared to traditional SSCs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Children aged 3 to 9 years old.
2. Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars, confirmed through clinical examination and radiographic assessment.
3. Requirement for restorative treatment in the form of either the SMART Hall technique or standard stainless steel crown (SSC) restoration, as determined by clinical assessment.
4. Willingness and ability of the parent/guardian to provide informed consent and ensure the child's attendance at follow-up appointments.
5. Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.

Exclusion Criteria:

1. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders) that may compromise treatment outcomes or pose risks during dental procedures.
2. Use of medications known to interfere with dental treatment or healing, such as anticoagulants or immunosuppressants, unless medically managed and deemed safe by the treating healthcare provider.
3. History of adverse reactions to dental materials or procedures that may contraindicate participation in the study.
4. Inability of the child to tolerate local anesthesia or undergo dental treatment due to psychological, behavioral, or developmental factors.
5. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.

Where it's running

• Dr Pakkirawadi Katika Saraswathi Bai
  Tirupati, Andhrapradesh, India Recruiting

Study contacts

• Principal investigator: Saraswathi Bai Pakkirawadi Katika, M.D.S — Post Graduate Student in Department of Pediatric Dentistry & Preventive Dentistry
• Study coordinator: Saraswathi Bai Pakkirawadi Katika, M.D.S
• Email: periopop@gmail.com
• Phone: +91 7032033850

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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.