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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-9
SponsorC K S Teja Institute Of Dental Sciences & Research

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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 through clinical examination and radiographic assessment.

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.

Willingness and ability of the parent/guardian to provide informed consent and ensure the child's attendance at follow-up appointments.

Disqualifiers

Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders) that may compromise treatment outcomes or pose risks during dental procedures.

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.

History of adverse reactions to dental materials or procedures that may contraindicate participation in the study.

Inability of the child to tolerate local anesthesia or undergo dental treatment due to psychological, behavioral, or developmental factors.

Trial design

Design model

Single group

Treatments tested in this trial

  • SMART Hall Technique or procedure

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single Arm Split-Mouth DesignExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful

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.

Time frame
Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.

Secondary outcomes

1

Minor failure

1. Crown Loss and Tooth Restorable: * Measurement Tool: Clinical examination * Description: Assessment of the presence or absence of crown loss where the tooth remains restorable. 2. Crown Perforation: * Measurement Tool: Clinical examination and radiographic evaluation * Description: Assessment of the integrity of the crown, specifically checking for any perforations. 3. Marginal Caries: * Measurement Tool: Clinical examination and radiographic evaluation * Description: Detection of caries at the margins of the crown. 4. Reversible Pulpitis: * Measurement Tool: Clinical examination, patient symptom reporting, and possibly radiographic evaluation * Description: Diagnosis of reversible pulpitis based on clinical signs and symptoms, such as pain that is not spontaneous and is relieved by analgesics or other treatment.

Time frame
Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.
2

Major failure

1. Irreversible Pulpitis: * Measurement Tool: Clinical examination, patient symptom reporting, and radiographic evaluation * Description: Diagnosis of irreversible pulpitis, characterized by persistent spontaneous pain not relieved by analgesics, confirmed through clinical and radiographic assessments. 2. Dental Abscess: * Measurement Tool: Clinical examination and radiographic evaluation * Description: Identification of a dental abscess, indicated by swelling, pus discharge, and radiographic evidence of infection. 3. Crown Loss and Tooth Unrestorable: * Measurement Tool: Clinical examination * Description: Assessment of crown loss where the tooth is deemed unrestorable, confirmed through clinical examination. 4. Periradicular Radiolucency: * Measurement Tool: Radiographic evaluation * Description: Detection of periradicular radiolucency, indicating potential periapical pathology, as observed in radiographic images.

Time frame
Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.

Other outcomes

Sponsors and contacts

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