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Comparative Evaluation of SMART Hall Technique Vs. Conventional SS Crown in Primary Molars: a Randomized Clinical Trial

Study acronym: RCT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Publications: details revised at 3 of 3 entriesv3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2024 to Jan 30, 2024
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06453005
Lead Sponsor C K S Teja Institute Of Dental Sciences & Research
Conditions
(from sponsor)
Caries,Dental, Pain, Plaque, Dental, Gingival Bleeding
Related terms Dental Caries, Dental Plaque, Gingival Hemorrhage, Pain
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov