[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584561":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":53,"collaborators":24,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":24,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":24,"overallStatus":76,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"(Group A : preformed Bioflx crown","EXPERIMENTAL","Kids-e-Dental LLP (ANDHERI, MUMBAI, INDIA) introduced Bioflx Crowns and claimed as the first flexible, durable, and esthetic preformed crown for primary molars. Bioflx 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: (Group A: Preformed Bioflx Crown)",{"label":15,"type":10,"description":16,"interventionNames":17},"(Group B: Preformed 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 seeking a highly esthetic and long-lasting pediatric restoration",[18],"Other: (Group B: Preformed Zirconia crown)",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"(Group A: Preformed Bioflx Crown)","Crown Selection \\& Tooth Preparation\n\nMeasure the mesiodistal width using calipers to select an appropriately sized crown.\n\nIf a mesial or distal wall is missing, use the contralateral tooth for size selection.\n\nChoose the crown that closely matches the measured mesiodistal width. Select the smallest crown that preserves proximal contacts using a trial-and-error approach.\n\nif crimping is necessary use Howe's pliers.\n\nTooth Preparation Perform 1-1.5 mm occlusal reduction using a tapered diamond bur. Reduce proximal areas by approximately 0.5 mm to clear the contact area.\n\nCrown Placement \\& Cementation Ensure 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 Remove 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},"(Group B: Preformed Zirconia crown)","Crown 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.\n\nChoose the crown that closely matches the measured 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. Reduce interproximal areas by 1-1.5 mm, ensuring a feather-edge finish. Perform a 1-2 mm subgingival preparation using a tapered fissure bur.\n\nCrown Placement \\& Passive Fit Check\n\nPlace the selected crown and check for passive fit.\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 proper seating.\n\nFinal Adjustments \\& Cleanup\n\nRemove excess cement using floss or an explorer. Verify fit, occlusion, and stability",[15],[30],{"name":31,"affiliation":5,"role":32},"Manal Ahmed Elshiekh, prof, PhD","STUDY_DIRECTOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Eithar musa Abdelrahman Hussion, Bachelor of dental science","CONTACT","00201098801323","Eithar.musa55@gmail.com",[40],{"facility":41,"status":24,"city":42,"state":43,"zip":44,"country":43,"countryCode":45,"cosmosGeoPoint":24,"geoPoint":24,"contacts":46},"Faculty of dentistry cairo university","Cairo ,Giza","Egypt","12613","EG",[47,50],{"name":41,"role":36,"phone":48,"phoneExt":24,"email":49},"0020223642705","rec@dentistry.cu.edu.eg",{"name":51,"role":52,"phone":24,"phoneExt":24,"email":24},"Eithar M Abdelrahman, BDS","PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Eithar Musa Abdelrahman Hussien","Principal investigator","100584561","occlusal-wear-of-bioflx-crowns-compared-to-zirconia-crowns-on-primary-molars-100584561",false,"NCT06890949","Occlusal Wear Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars","Evaluation Of Occlusal Wear Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars","Inclusion Criteria:\n\n1. Children aged between 4 and 8 years with primary molar that needs to be covered by crown.\n2. Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).\n3. Children whose parent or guardian are willing to sign an informed consent.\n4. Children whose parent or guardian are willing to comply with follow-up visits. -\n5. Frankl's positive and definitely positive patient\n\nExclusion Criteria:\n\n1. Molars with severe structural loss that may compromise crown retention.\n2. Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.\n3. Children with history of allergies; Known allergies to dental local anesthesia or to the materials used in Bioflx crowns.\n4. Children with any systemic conditions or disabilities that may affect their ability to participate in the study.",true,"ALL","4 Years","8 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to evaluate the occlusal wear of Bioflx crowns compared to zirconia crowns in the restoration of primary molars.\n\nThe main question\\[s\\] it aims to answer : \" Is there a difference in the occlusal wear of BioFlx crowns compared to zirconia crowns in the restoration of primary molars?\" The study will also assess the clinical performance of both types of crowns in terms of retention,gingival health, preparation time, as well as child and parental satisfaction.",[75],"Carious Primary Molars","NOT_YET_RECRUITING","2025-03-20",{"date":79,"type":80},"2025-03-24","ACTUAL",{"date":82,"type":69},"2025-06-15",{"date":84,"type":69},"2026-07-16",{"name":5,"class":6},1]