Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-02-28 @ 7:34 PM
Study NCT ID:
NCT06453005
Status:
RECRUITING
Last Update Posted:
2025-03-03
First Post:
2024-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of SMART Hall Technique Vs. Conventional SS Crown in Primary Molars: a Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D005884', 'term': 'Gingival Hemorrhage'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D006472', 'term': 'Oral Hemorrhage'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2024-05-25', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful', 'timeFrame': 'Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.', 'description': '1. Restoration Satisfactory: The restoration appears satisfactory upon clinical examination, with no visible defects or issues.\n\n \\- No Intervention Required: The tooth does not require any additional intervention post-restoration.\n2. Absence of Pulpal Pathology:\n\n * 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.\n * No Pulpal Pathology Visible on X-Ray: Radiographic evaluation shows no signs of pulpal pathology, such as radiolucency or periapical lesions.\n3. Tooth Exfoliation:\n\n * Natural Tooth Exfoliation: The tooth exfoliates naturally, without the need for extraction.'}], 'secondaryOutcomes': [{'measure': 'Minor failure', 'timeFrame': 'Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.', 'description': '1. Crown Loss and Tooth Restorable:\n\n * Measurement Tool: Clinical examination\n * Description: Assessment of the presence or absence of crown loss where the tooth remains restorable.\n2. Crown Perforation:\n\n * Measurement Tool: Clinical examination and radiographic evaluation\n * Description: Assessment of the integrity of the crown, specifically checking for any perforations.\n3. Marginal Caries:\n\n * Measurement Tool: Clinical examination and radiographic evaluation\n * Description: Detection of caries at the margins of the crown.\n4. Reversible Pulpitis:\n\n * Measurement Tool: Clinical examination, patient symptom reporting, and possibly radiographic evaluation\n * 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.'}, {'measure': 'Major failure', 'timeFrame': 'Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.', 'description': '1. Irreversible Pulpitis:\n\n * Measurement Tool: Clinical examination, patient symptom reporting, and radiographic evaluation\n * Description: Diagnosis of irreversible pulpitis, characterized by persistent spontaneous pain not relieved by analgesics, confirmed through clinical and radiographic assessments.\n2. Dental Abscess:\n\n * Measurement Tool: Clinical examination and radiographic evaluation\n * Description: Identification of a dental abscess, indicated by swelling, pus discharge, and radiographic evidence of infection.\n3. Crown Loss and Tooth Unrestorable:\n\n * Measurement Tool: Clinical examination\n * Description: Assessment of crown loss where the tooth is deemed unrestorable, confirmed through clinical examination.\n4. Periradicular Radiolucency:\n\n * Measurement Tool: Radiographic evaluation\n * Description: Detection of periradicular radiolucency, indicating potential periapical pathology, as observed in radiographic images.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized Clinical Trial', 'Dental caries', 'Primary molars', 'Stainless Steel Crowns', 'SMART Hall Technique', 'Conventional Technique', 'Silver Diamine Fluoride', 'Split Mouth Study'], 'conditions': ['Caries,Dental', 'Pain', 'Plaque, Dental', 'Gingival Bleeding']}, 'referencesModule': {'references': [{'pmid': '32476119', 'type': 'BACKGROUND', 'citation': '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': '33851682', 'type': 'BACKGROUND', 'citation': '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': '25429038', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nSilver 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.\n\nTo 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.\n\nThis 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.", 'detailedDescription': '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.\n\nOBJECTIVES OF THE STUDY\n\n1. 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.\n2. 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.\n3. 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.\n4. 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.\n5. To analyze and compare patient-reported perceptions of treatment using a Visual Analogue Scale between the two treatment modalities.\n\nINCLUSION CRITERIA\n\n1. Children aged 3 to 9 years old.\n2. Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars, confirmed through clinical examination and radiographic assessment.\n3. 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.\n4. Willingness and ability of the parent/guardian to provide informed consent and ensure the child\'s attendance at follow-up appointments.\n5. Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.\n\nEXCLUSION CRITERIA\n\n1. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders) that may compromise treatment outcomes or pose risks during dental procedures.\n2. 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.\n3. History of adverse reactions to dental materials or procedures that may contraindicate participation in the study.\n4. Inability of the child to tolerate local anesthesia or undergo dental treatment due to psychological, behavioral, or developmental factors.\n5. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.\n\nMETHODOLOGY 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.\n\nSampling method:\n\nProbability sampling method, Simple Random sampling method using random number generators (RNGs)\n\nBlinding:\n\nPatients, 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.\n\nTraining of examining clinicians:\n\nTo standardize the methods for training examiners in assessing clinical and radiographical outcomes, following steps will be followed:\n\n1. Standardized protocol: These will outline the criteria and methods for assessing clinical and radiographical outcomes.\n2. Training sessions: Conducting training sessions for the examiners to familiarize them with the standardized protocols.\n3. Practice cases: Providing examiners with practice cases to assess using the standardized protocol.\n4. 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.\n\nAssessing 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.\n\nBlinding 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.\n\nCriteria for Clinical Assessment are as follows:\n\nSuccessful\n\n* Restoration appears satisfactory. No intervention required.\n* No clinical sign or symptom of pulpal pathology\n* No pulpal pathology visible on X-Ray.\n* Tooth exfoliated\n\nMinor failure\n\n* Crown loss and tooth restorable\n* Crown perforation\n* Marginal caries\n* Reversible pulpitis.\n\nMajor failure\n\n* Irreversible pulpitis\n* Dental abscess\n* Crown loss and tooth is unrestorable\n* Periradicular radiolucency\n\nClinical Parameters used in assessment are as follows:\n\n* Pain - Present / Absent\n* Mobility - Present / Absent\n* Tender on percussion - Present / Absent\n* Abscess or Sinus - Present / Absent\n\nRadiographical Parameters used in assessment are as follows:\n\n* No abnormal findings - Present / Absent\n* Root resorption - Present / Absent\n* Periapical pathology - Present / Absent\n* Internal resorption - Present / Absent\n* Furcation involvement - Present / Absent\n\nThe Visual Analogue Scale (VAS) will be utilized to evaluate patients\' treatment experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Children aged 3 to 9 years old.\n2. Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars, confirmed through clinical examination and radiographic assessment.\n3. 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.\n4. Willingness and ability of the parent/guardian to provide informed consent and ensure the child's attendance at follow-up appointments.\n5. Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.\n\nExclusion Criteria:\n\n1. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders) that may compromise treatment outcomes or pose risks during dental procedures.\n2. 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.\n3. History of adverse reactions to dental materials or procedures that may contraindicate participation in the study.\n4. Inability of the child to tolerate local anesthesia or undergo dental treatment due to psychological, behavioral, or developmental factors.\n5. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study."}, 'identificationModule': {'nctId': 'NCT06453005', 'acronym': 'RCT', 'briefTitle': 'Comparative Evaluation of SMART Hall Technique Vs. Conventional SS Crown in Primary Molars: a Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'C K S Teja Institute Of Dental Sciences & Research'}, 'officialTitle': 'Comparative Evaluation of SMART Hall Technique Versus Conventional SS Crown Restoration in Treatment of Carious Primary Molars - a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CKSTeja'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm Split-Mouth Design', 'description': "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.", 'interventionNames': ['Procedure: SMART Hall Technique or procedure']}], 'interventions': [{'name': 'SMART Hall Technique or procedure', 'type': 'PROCEDURE', 'otherNames': ['Conventional Stainless Steel Crown restoration'], 'description': '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.\n\nThe 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.', 'armGroupLabels': ['Single Arm Split-Mouth Design']}]}, 'contactsLocationsModule': {'locations': [{'zip': '517501', 'city': 'Tirupati', 'state': 'Andhrapradesh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Saraswathi bai Pakkirawadi Katika, M.D.S', 'role': 'CONTACT', 'email': 'periopop@gmail.com', 'phone': '+91 7032033850'}], 'facility': 'Dr Pakkirawadi Katika Saraswathi Bai', 'geoPoint': {'lat': 13.63551, 'lon': 79.41989}}], 'centralContacts': [{'name': 'Saraswathi Bai Pakkirawadi Katika, M.D.S', 'role': 'CONTACT', 'email': 'periopop@gmail.com', 'phone': '+91 7032033850'}], 'overallOfficials': [{'name': 'Saraswathi Bai Pakkirawadi Katika, M.D.S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate Student in Department of Pediatric Dentistry & Preventive Dentistry'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available from November 2025 until March 2026.', 'ipdSharing': 'YES', 'description': 'Relevant masked IPD that underlie results in a publication will be shared.', 'accessCriteria': 'Access on request to only researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C K S Teja Institute Of Dental Sciences & Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post Graduate Student', 'investigatorFullName': 'P K Saraswathi Bai', 'investigatorAffiliation': 'C K S Teja Institute Of Dental Sciences & Research'}}}}