[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590542":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":45,"responsibleParty":64,"collaborators":24,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":24,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":24,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":24,"overallStatus":87,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"group A performed bioflx crown","EXPERIMENTAL","(Nu smile, united state) introduced Biofix Crowns and claimed as the first flexible, durable, and esthetic preformed crown for primary molars. Biofix Crowns are monochromatic, metal-free, tooth-colored crowns made up of high-strength resin polymer used in the medical device industry having high strength, flexibility, and durability. These crowns are autoclavable and are like SSC in tooth preparation as claimed by the manufacturer. Their flexibility and snap-fit technology aim to improve retention while minimizing trauma during placement.",[13],"Other: bioflx crown",{"label":15,"type":10,"description":16,"interventionNames":17},"group B performed zirconia crown","NuSmile Zirconia Crowns are prefabricated, esthetic full-coverage restorations designed for primary teeth. Known for their superior strength, durability, and natural tooth-like appearance, these crowns provide an excellent alternative to traditional stainless steel crowns. Made from high-quality medical-grade zirconia, they are biocompatible, resistant to chipping, and highly polished to minimize plaque accumulation and gingival irritation.\n\nNuSmile Zirconia Crowns require significant tooth preparation for proper fit and retention. They are available in various sizes to accommodate different primary molars and anterior teeth. Their lifelike translucency and color-matching capabilities make them a preferred choice for parents and clinicians.",[18],"Other: zirconia crown",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"bioflx crown","(Group A: Preformed Biofix Crown - Assigned Intervention)\n\nCrown Selection \\& Tooth Preparation:\n\nMeasure the mesiodistal width using calipers to select an appropriately sized crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured mesiodistal width. Select the smallest crown that preserves proximal contacts using a trial-and-error approach. If crimping is necessary, use Howe's pliers.\n\nPerform 1-1.5 mm occlusal reduction using a tapered diamond bur.\n\nReduce proximal areas by approximately 0.5 mm to clear the contact area.\n\nCrown Placement \\& Cementation:\n\nEnsure a snug fit of the selected crown. Apply a thin layer of glass ionomer cement inside the crown. Seat the crown firmly using finger pressure. Have the child bite down gently to ensure proper seating.\n\nFinal Adjustments \\& Cleanup:\n\nRemove excess cement with floss or an explorer. Verify the crown's fit, occlusion, and stability.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"zirconia crown","Group B: Preformed Zirconia Crown - Assigned Intervention)\n\nCrown Selection:\n\nMeasure the mesiodistal width using calipers to select the appropriate crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the one that closely matches the mesiodistal width. Select the smallest crown that preserves proximal contacts.\n\nTooth Preparation:\n\nReduce the occlusal surface by 1.5-2 mm using a tapered diamond bur.\n\nReduce interproximal areas by 1-1.5 mm, ensuring a feather-edge finish.\n\nPerform a 1-2 mm subgingival preparation in passively placed fissure bur.\n\nCrown Placement \\& Passive Fit Check:\n\nPlace the selected crown on the prepared tooth.\n\nCementation of the Crown:\n\nApply a thin layer of glass ionomer cement inside the crown. Seat the crown with passive finger pressure. Have the child bite down gently to ensure seating.",[15],[30],{"name":31,"affiliation":32,"role":33},"Hala m Alshaeri, Bachelor of Dental surgery","Cairo university faculty of dentistry","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"halah M alshaeri, Bachelor of Dental surgery","CONTACT","00201149038858","002","hala.mosaed@dentistry.cu.edu.eg",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Manal A Elshiekh, prof, phd","0223642705","rec@dentistry.cu.edu.eg",[46],{"facility":47,"status":24,"city":48,"state":49,"zip":50,"country":49,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Faculty of Dentistry Cairo University","Cairo","Egypt","12613","EG",{"type":53,"coordinates":54},"Point",[55,56],31.24967,30.06263,{"lat":56,"lon":55},[59,62],{"name":60,"role":37,"phone":61,"phoneExt":24,"email":44},"faculty of dentistry cairo university","0020223642705",{"name":63,"role":33,"phone":24,"phoneExt":24,"email":24},"hala mosaed ali alshaeri, bachelore of dental science",{"type":33,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Halah Mosaed Ali Alshaeri","principle investigator","100590542","preparation-time-of-bioflx-crowns-compared-to-zirconia-crowns-on-primary-molars-100590542",false,"NCT06968767","Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars","Evaluation Of Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars","Inclusion Criteria:\n\n* Children aged between 4 and 8 years with a primary molar that needs to be covered by a crown.\n\nMedically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).\n\nChildren whose parent or guardian is willing to sign an informed consent.\n\nChildren whose parent or guardian are willing to comply with follow-up visits.\n\nFrankl's positive and definitely positive patient.\n\nExclusion Criteria:\n\n* Molars with severe structural loss that may compromise crown retention.\n\nChildren with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.\n\nChildren with a history of allergies; known allergies to dental local anesthesia or to the materials used in Biofix crowns.\n\nChildren with any systemic conditions or disabilities that may affect their ability to participate in the study.",true,"ALL","4 Years","8 Years",{"count":79,"type":80},22,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study aims to evaluate and compare the preparation time required for Bioflx crowns versus zirconia crowns on primary molars through a randomized clinical trial.\n\n• Primary Objective: To compare the preparation time required for Bioflex crowns and zirconia crowns on primary molars in pediatric patients.\n\n• Secondary Objectives:\n\nTo evaluate the clinical performance of Bioflex crowns compared to zirconia crowns, including:\n\nRetention, Patient Satisfaction, Parental Satisfaction, Occlusal Wear and Gingival Health.\n\nthe main question it aim to answer: Is there a significant difference in the preparation time required for Bioflx crowns compared to zirconia crowns in the primary molars of pediatric patients?",[86],"Carious Primary Molars","NOT_YET_RECRUITING","2025-05-05",{"date":90,"type":91},"2025-05-13","ACTUAL",{"date":93,"type":80},"2025-06-15",{"date":95,"type":80},"2026-06-16",{"name":5,"class":6},1]