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

Comparative Evaluation of SMART Hall Technique Versus Conventional SS Crown Restoration in Treatment of Carious Primary Molars - a Randomized Clinical 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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Plaque, Dental; Caries,Dental; Gingival Bleeding
• Intervention / Treatment: Procedure: SMART Hall Technique or procedure

Detailed Description

AIM OF THE STUDY The aim of this research study is to compare the treatment outcomes of the SMART Hall technique with conventional stainless steel crown (SSC) restoration for managing occluso-proximal carious lesions (ICDAS CODE 3/4/5) in primary molars of 3- to 9-year-old children.

OBJECTIVES OF THE STUDY

1. To evaluate and compare the clinical success rates of the SMART Hall technique and conventional SSC restoration in managing occluso-proximal carious lesions in primary molars over a follow-up period of 3 & 6 months.
2. To evaluate and compare the treatment time duration of the SMART Hall technique and conventional SSC restoration in managing occluso-proximal carious lesions in primary molars.
3. To assess and compare the survival rates of teeth restored using the SMART Hall technique and conventional SSC restoration over a follow-up period of 3 & 6 months.
4. To assess and compare the radiographical outcomes of teeth restored using the SMART Hall technique and conventional SSC restoration over a follow-up period of 3 & 6 months.
5. To analyze and compare patient-reported perceptions of treatment using a Visual Analogue Scale between the two treatment modalities.

INCLUSION CRITERIA

1. Children aged 3 to 9 years old.
2. Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars, confirmed through clinical examination and radiographic assessment.
3. Requirement for restorative treatment in the form of either the SMART Hall technique or conventional stainless steel crown (SSC) restoration, as determined by clinical assessment.
4. Willingness and ability of the parent/guardian to provide informed consent and ensure the child's attendance at follow-up appointments.
5. Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.

EXCLUSION CRITERIA

1. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders) that may compromise treatment outcomes or pose risks during dental procedures.
2. 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.
3. History of adverse reactions to dental materials or procedures that may contraindicate participation in the study.
4. Inability of the child to tolerate local anesthesia or undergo dental treatment due to psychological, behavioral, or developmental factors.
5. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.

METHODOLOGY Patients attending the Department Pedodontics & Preventive Dentistry department will be screened for identifying patients who fit into the inclusion & exclusion criteria. A total of 50 patients will be listed accordingly. Patients' parents / Guardian will be explained about the research study and treatments involved. Further, 25 patients will be randomly selected according to the determined sample size. Additional 5 patients will be recruited keeping in my the possibility of case attrition. A simple random selection method will be employed using Microsoft Excel program to generate patient pool to participate in this split mouth study.

Sampling method:

Probability sampling method, Simple Random sampling method using random number generators (RNGs)

Blinding:

Patients, Biostatistician and trained clinicians involved in evaluating clinical and radiographical outcomes will be kept blind about the type of treatment done in which primary tooth.

Training of examining clinicians:

To standardize the methods for training examiners in assessing clinical and radiographical outcomes, following steps will be followed:

1. Standardized protocol: These will outline the criteria and methods for assessing clinical and radiographical outcomes.
2. Training sessions: Conducting training sessions for the examiners to familiarize them with the standardized protocols.
3. Practice cases: Providing examiners with practice cases to assess using the standardized protocol.
4. Calibration exercises: Conducting calibration exercises to assess inter-examiner and intra-examiner variability. In these exercises, multiple examiners independently assess the same set of cases using the standardized protocol.

Assessing inter-examiner and intra-examiner variability: Intraclass Correlation Coefficient (ICC) statistical test will be employed to check for both inter-examiner and intra-examiner variability.

Blinding of biostatistician: Blinding the biostatistician to the type of treatment modality to minimize potential bias in data analysis. Providing data labeled as "treatment modality 1" and "treatment modality 2" in the Excel sheet effectively conceals the treatment assignment from the biostatistician.

Criteria for Clinical Assessment are as follows:

Successful

• Restoration appears satisfactory. No intervention required.
• No clinical sign or symptom of pulpal pathology
• No pulpal pathology visible on X-Ray.
• Tooth exfoliated

Minor failure

• Crown loss and tooth restorable
• Crown perforation
• Marginal caries
• Reversible pulpitis.

Major failure

• Irreversible pulpitis
• Dental abscess
• Crown loss and tooth is unrestorable
• Periradicular radiolucency

Clinical Parameters used in assessment are as follows:

• Pain - Present / Absent
• Mobility - Present / Absent
• Tender on percussion - Present / Absent
• Abscess or Sinus - Present / Absent

Radiographical Parameters used in assessment are as follows:

• No abnormal findings - Present / Absent
• Root resorption - Present / Absent
• Periapical pathology - Present / Absent
• Internal resorption - Present / Absent
• Furcation involvement - Present / Absent

The Visual Analogue Scale (VAS) will be utilized to evaluate patients' treatment experience.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saraswathi bai Pakkirawadi Katika, M.D.S; Phone Number: +91 7032033850; Email: periopop@gmail.com

Study Locations

• India
  • Andhrapradesh
    • Tirupati, Andhrapradesh, India, 517501
      • Recruiting
      • Dr Pakkirawadi Katika Saraswathi Bai
      • Contact: Saraswathi bai Pakkirawadi Katika, M.D.S; Phone Number: +91 7032033850; Email: periopop@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Children aged 3 to 9 years old.
2. Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars, confirmed through clinical examination and radiographic assessment.
3. 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.
4. Willingness and ability of the parent/guardian to provide informed consent and ensure the child's attendance at follow-up appointments.
5. Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.

Exclusion Criteria:

1. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders) that may compromise treatment outcomes or pose risks during dental procedures.
2. 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.
3. History of adverse reactions to dental materials or procedures that may contraindicate participation in the study.
4. Inability of the child to tolerate local anesthesia or undergo dental treatment due to psychological, behavioral, or developmental factors.
5. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm Split-Mouth Design; 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; 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.; Other Names: Conventional Stainless Steel Crown restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful	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.; 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.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor failure	Crown Loss and Tooth Restorable:Measurement Tool: Clinical examinationDescription: Assessment of the presence or absence of crown loss where the tooth remains restorable.; Crown Perforation:Measurement Tool: Clinical examination and radiographic evaluationDescription: Assessment of the integrity of the crown, specifically checking for any perforations.; Marginal Caries:Measurement Tool: Clinical examination and radiographic evaluationDescription: Detection of caries at the margins of the crown.; Reversible Pulpitis:Measurement Tool: Clinical examination, patient symptom reporting, and possibly radiographic evaluationDescription: 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.	Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.
Major failure	Irreversible Pulpitis:Measurement Tool: Clinical examination, patient symptom reporting, and radiographic evaluationDescription: Diagnosis of irreversible pulpitis, characterized by persistent spontaneous pain not relieved by analgesics, confirmed through clinical and radiographic assessments.; Dental Abscess:Measurement Tool: Clinical examination and radiographic evaluationDescription: Identification of a dental abscess, indicated by swelling, pus discharge, and radiographic evidence of infection.; Crown Loss and Tooth Unrestorable:Measurement Tool: Clinical examinationDescription: Assessment of crown loss where the tooth is deemed unrestorable, confirmed through clinical examination.; Periradicular Radiolucency:Measurement Tool: Radiographic evaluationDescription: Detection of periradicular radiolucency, indicating potential periapical pathology, as observed in radiographic images.	Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.

Collaborators and Investigators

• Sponsor: C K S Teja Institute Of Dental Sciences & Research
• Investigators: Principal Investigator: Saraswathi Bai Pakkirawadi Katika, M.D.S, Post Graduate Student in Department of Pediatric Dentistry & Preventive Dentistry

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: May 25, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Silver Diamine Fluoride; Dental caries; Randomized Clinical Trial; Primary molars; Stainless Steel Crowns; Conventional Technique; SMART Hall Technique; Split Mouth Study
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Tooth Diseases; Hemorrhage; Gingival Diseases; Dental Deposits; Tooth Demineralization; Oral Hemorrhage; Dental Plaque; Dental Caries; Gingival Hemorrhage
• Other Study ID Numbers: CKSTeja

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Relevant masked IPD that underlie results in a publication will be shared.
• IPD Sharing Time Frame: Data will be available from November 2025 until March 2026.
• IPD Sharing Access Criteria: Access on request to only researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No