Comparing two techniques for treating cavities in children's back teeth
Comparative Evaluation of SMART Hall Technique Versus Conventional SS Crown Restoration in Treatment of Carious Primary Molars - a Randomized Clinical Trial
This study is testing whether a new way to treat cavities in kids' back teeth works better than the traditional method to see which one is more effective and comfortable for children aged 3 to 9.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 9 Years |
| Sex | All |
| Sponsor | C K S Teja Institute Of Dental Sciences & Research Academic / other |
| Locations | 1 site (Tirupati, Andhrapradesh) |
| Trial ID | NCT06453005 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 9 years with occluso-proximal carious lesions in primary molars.
Not a fit: Patients with severe systemic medical conditions or those requiring medications that interfere with dental treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more effective treatment option for managing dental caries in young children.
How similar studies have performed: While the SMART Hall technique is a newer approach, previous studies on similar minimally invasive techniques have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tirupati, Andhrapradesh
- 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
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.