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

Condition(s) studied

Investigational drug(s) / intervention(s)

SMART Hall Technique or procedure: The SMART Hall technique, a minimally invasive approach in pediatric dentistry for managing caries in primary teeth, involves gentle cavity preparation using hand instruments and minimal local anesthesia. A glass ionomer cement is used for restoration, followed by crown adaptation and cementation. Postoperative care and follow-up assessments at 3 and 6 months are included. The Stainless Steel Crown (SSC) technique for restoring extensively decayed primary molars involves tooth preparation, crown selection, adaptation, and cementation. Postoperative care and follow-up assessments at 3 and 6 months are also part of the procedure.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Successful — Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.
  1. Restoration Satisfactory: The restoration appears satisfactory upon clinical examination, with no visible defects or issues. \- No Intervention Required: The tooth does not require any additional intervention post-restoration. 2. Absence of Pulpal Pathology: * No Clinical Signs or Symptoms of Pulpal Pathology: The patient exhibits no clinical signs or symptoms indicative of pulpal pathology, such as pain, swelling, or sensitivity. * No Pulpal Pathology Visible on X-Ray: Radiographic evaluation shows no signs of pulpal pathology, such as radiolucency or periapical lesions. 3. Tooth Exfoliation: * Natural Tooth Exfoliation: The tooth exfoliates naturally, without the need for extraction.

Trial sites (1)