Actively Recruiting
Comparative Evaluation of SMART Hall Technique Vs. Conventional SS Crown in Primary Molars: a Randomized Clinical Trial
Led by C K S Teja Institute Of Dental Sciences & Research · Updated on 2025-03-03
30
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dental caries, particularly in primary molars, significantly affects children's oral health and overall well-being. Traditional management with stainless steel crowns (SSCs) involves significant tooth reduction and advanced dental skills. Introduced in the 1970s, the Hall technique offers a less invasive alternative, minimizing tooth reduction compared to SSCs. The SMART Hall technique represents a further evolution, emphasizing atraumatic cavity preparation using hand instruments. It offers advantages like minimal or no tooth reduction, minimized discomfort, improved patient cooperation, shorter treatment times, and cost-effectiveness. Silver Diamine Fluoride (SDF) emerges as a promising non-invasive approach for managing dental caries in primary teeth, though it may cause temporary tooth discoloration. However, comparative evaluation with traditional SSC restorations remains limited. To address this gap, a randomized clinical trial will evaluate the treatment outcomes of the SMART Hall technique versus conventional SSC restoration for managing occluso-proximal carious lesions (ICDAS CODE 3/4/5) in primary molars of young patients. Children aged 3 to 9 years requiring restorations will be included, assessing clinical outcomes, treatment time duration, and radiographical outcomes of both techniques at specific follow-up intervals of 3 months \& 6 months. This split mouth study will explore Clinical outcomes, radiographical outcomes, treatment time duration, and patient's pain perception with the chosen treatment modality. The findings will provide insights into the effectiveness and feasibility of the SMART Hall technique compared to the traditional SSC approach, informing evidence-based decision-making in pediatric dentistry and influencing treatment recommendations for preserving the health and function of primary molars in young children.
CONDITIONS
Official Title
Comparative Evaluation of SMART Hall Technique Vs. Conventional SS Crown in Primary Molars: a Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 9 years old
- Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars confirmed by clinical and radiographic exam
- Need for restorative treatment using either the SMART Hall technique or conventional stainless steel crown restoration
- Parent or guardian willing and able to provide consent and ensure follow-up attendance
- Child able to cooperate during dental treatment and evaluation as judged by the clinician
You will not qualify if you...
- Severe systemic medical conditions such as uncontrolled diabetes or immunodeficiency disorders that may affect treatment or pose risks
- Use of medications interfering with dental treatment or healing unless medically managed and considered safe
- History of adverse reactions to dental materials or procedures contraindicating study participation
- Child unable to tolerate local anesthesia or dental treatment due to psychological, behavioral, or developmental reasons
- Extensive dental caries or other oral diseases needing urgent or specialized dental care beyond this study's scope
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dr Pakkirawadi Katika Saraswathi Bai
Tirupati, Andhrapradesh, India, 517501
Actively Recruiting
Research Team
S
Saraswathi Bai Pakkirawadi Katika, M.D.S
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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