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

NCT06453005 | Recruiting

• 1 other identifier: CKSTeja
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caries,Dental; Pain; Plaque, Dental; Gingival Bleeding

Keywords

Randomized Clinical Trial; Dental caries; Primary molars; Stainless Steel Crowns; SMART Hall Technique; Conventional Technique; Silver Diamine Fluoride; Split Mouth Study

Outcome Measures

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.

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

Secondary Outcomes (2)

• Minor failure

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

• Major failure

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

Study Arms (1)

Single Arm Split-Mouth Design

EXPERIMENTAL

Our study involves comparing two different dental treatment modalities, the SMART Hall technique and standard Stainless Steel Crown (SSC) restoration, in a split-mouth design. In this design, each participant serves as their own control, receiving both interventions sequentially. The 'Single Arm' model aligns with our study structure, indicating that all participants receive both treatment modalities. This approach is consistent with our split-mouth study design, where each participant acts as their own control.

Procedure: SMART Hall Technique or procedure

Interventions

SMART Hall Technique or procedure 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.

Also known as: Conventional Stainless Steel Crown restoration

Single Arm Split-Mouth Design

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.

You may not qualify if:

• 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.
• Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.

Sponsors & Collaborators

• C K S Teja Institute Of Dental Sciences & Research: lead

Study Sites (1)

Dr Pakkirawadi Katika Saraswathi Bai

Tirupati, Andhrapradesh, 517501, India

RECRUITING

Related Publications (3)

• Ayedun OS, Oredugba FA, Sote EO. Comparison of the Treatment Assessments of the Conventional Stainless-Steel Crown Restorations and the Hall Technique. West Afr J Med. 2020 Jul-Aug;37(3):253-259.

  PMID: 32476119 BACKGROUND

• Ayedun OS, Oredugba FA, Sote EO. Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the hall technique in the treatment of carious primary molars. Niger J Clin Pract. 2021 Apr;24(4):584-594. doi: 10.4103/njcp.njcp_460_20.

  PMID: 33851682 BACKGROUND

• Ludwig KH, Fontana M, Vinson LA, Platt JA, Dean JA. The success of stainless steel crowns placed with the Hall technique: a retrospective study. J Am Dent Assoc. 2014 Dec;145(12):1248-53. doi: 10.14219/jada.2014.89.

  PMID: 25429038 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Pain; Dental Plaque; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dental Deposits; Oral Hemorrhage; Mouth Diseases; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes

Study Officials

• Saraswathi Bai Pakkirawadi Katika, M.D.S

  Post Graduate Student in Department of Pediatric Dentistry & Preventive Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saraswathi Bai Pakkirawadi Katika, M.D.S

CONTACT

+91 7032033850; periopop@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are masked to treatment allocation, while care providers and investigators are not. Outcomes assessors remain masked to minimize bias. The biostatistician is blinded to treatment modality to avoid bias in data analysis, with data labeled as "treatment modality 1" and "treatment modality 2" in the Excel sheet.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Student

Model Details: Our study involves comparing two different dental treatment modalities (SMART Hall technique and standard SSC restoration) in a split-mouth design, where each participant serves as their control, the Single group model aligns with the structure of your study. This model indicates that all participants receive the intervention(s) being studied, which is consistent with our split-mouth study design.

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: June 11, 2024
• Study Start: January 30, 2024
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available from November 2025 until March 2026.
• Access Criteria: Access on request to only researchers.

Locations

IN (1)