[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550894":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":33,"responsibleParty":51,"collaborators":31,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":31,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":36,"whyStopped":31,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"C K S Teja Institute Of Dental Sciences & Research","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: SMART Hall Technique or procedure",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.\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.",[9],[21],"Conventional Stainless Steel Crown restoration",[23],{"name":24,"affiliation":25,"role":26},"Saraswathi Bai Pakkirawadi Katika, M.D.S","Post Graduate Student in Department of Pediatric Dentistry & Preventive Dentistry","PRINCIPAL_INVESTIGATOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","+91 7032033850",null,"periopop@gmail.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Dr Pakkirawadi Katika Saraswathi Bai","RECRUITING","Tirupati","Andhrapradesh","517501","India","IN",{"type":43,"coordinates":44},"Point",[45,46],79.41989,13.63551,{"lat":46,"lon":45},[49],{"name":50,"role":29,"phone":30,"phoneExt":31,"email":32},"Saraswathi bai Pakkirawadi Katika, M.D.S",{"type":26,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"P K Saraswathi Bai","Post Graduate Student","100550894","comparative-evaluation-of-smart-hall-technique-vs-conventional-ss-crown-in-primary-molars-a-randomized-clinical-trial-100550894",false,"NCT06453005","Comparative Evaluation of SMART Hall Technique Vs. Conventional SS Crown in Primary Molars: a Randomized Clinical Trial","Comparative Evaluation of SMART Hall Technique Versus Conventional SS Crown Restoration in Treatment of Carious Primary Molars - a Randomized Clinical Trial","RCT","Inclusion Criteria:\n\n1. Children aged 3 to 9 years old.\n2. Presence of occluso-proximal carious lesions (ICDAS CODE 3\u002F4\u002F5) 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\u002Fguardian 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.",true,"ALL","3 Years","9 Years",{"count":67,"type":68},30,"ESTIMATED","INTERVENTIONAL",[71],"NA","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\u002F4\u002F5) 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.",[74,75,76,77],"Caries,Dental","Pain","Plaque, Dental","Gingival Bleeding",[79,80,81,82,83,84,85,86],"Randomized Clinical Trial","Dental caries","Primary molars","Stainless Steel Crowns","SMART Hall Technique","Conventional Technique","Silver Diamine Fluoride","Split Mouth Study","2025-02-27",{"date":89,"type":90},"2025-03-03","ACTUAL",{"date":92,"type":90},"2024-01-30",{"date":94,"type":68},"2025-04-01",{"name":5,"class":6},1]