[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587864":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":35,"locations":41,"responsibleParty":49,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":24,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":24,"overallStatus":72,"whyStopped":24,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bioflex crowns","EXPERIMENTAL","Bioflx Crowns (BFCs) the first flexible, durable, and esthetic preformedcrown for primary molars .BFCs are monochromatic, metal-free, tooth-colored crowns used in the medical device industry having high strength, flexibility, and durability. These crowns are autoclavable and are similar to SSC in tooth preparation. Additionally, they offer a cost benefit compared to zircon crowns",[13],"Other: (Group A: Bioflx crowns)",{"label":15,"type":10,"description":16,"interventionNames":17},"Zirconia crowns","zirconia crowns are frequently chosen as a comparator due to their established clinical performance and favorable biological properties. Studies have demonstrated that zirconia crowns exhibit lower bacterial adhesion, particularly of Streptococcus mutans, compared to stainless steel crowns (SSCs). highly polished and smooth surface of zirconia, which minimizes plaque accumulation and subsequent gingival inflammation.",[18],"Other: (Group B) : Preformed Zirconia crown",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"(Group A: Bioflx crowns)","Minimal preparation will be required due to their flexural adaptability:1. Choose an appropriately sized Bioflex (Nusmile) crown of similar size to the mesiodistal width.2. The tooth will be prepared using a flame stone for occlusal reduction by 1-1.5 mm, including the central groove .3Proximal preparation will be around 0.5 mm, by using a fine, long, tapered diamond stone to cut interproximal slices mesially and distally.4. The crown will be placed with a snug fit and cemented using glass ionomer",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"(Group B) : Preformed Zirconia crown","1\\. Size Determination can be achieved by holding a crown up to the existing tooth or, if available, using digital x-ray measurements to match the patient's interproximal width to the corresponding crown size.2. OcclusalPerform an occlusal reduction of about 1.5-2 mm, ensuring adequate space for the crown material. 3. Axial ReductionReduce the buccal and lingual surfaces uniformly, ensuring the removal of any prominent buccal bulges to allow for a passive crown fit. 4. Interproximal ReductionClearance: Ensure sufficient interproximal space by removing enough tooth structure to allow the crown to seat without interference.5. Subgingival PreparationMargin Placement: Extend the preparation subgingivally by approximately 2 mm to achieve optimal crown retention and aesthetics. This involves removing the chamfer margin at the tissue level and ensuring a smooth transition from the root to the coronal tooth structure",[15],[30,33],{"name":31,"affiliation":5,"role":32},"Manal Ahmed Elsheikh, PHD","STUDY_DIRECTOR",{"name":34,"affiliation":5,"role":32},"Shaimaa Mohamed Sabry mostafa, PHD",[36],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Salma Ahmed Abdelrazig, Master degree","CONTACT","00201022584032","Salma.abdelrazig@dentistry.cu.edu.eg",[42],{"facility":43,"status":24,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":24,"geoPoint":24,"contacts":24},"Faculty of dentistry cairo university","Cairo","Giza Governorate","12613","Egypt","EG",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Salma Ahmed Abdelrazig Mohammed","principal investigator","100587864","comparative-evaluation-of-gingival-health-and-bacterial-adhesion-in-bioflx-vs-zirconia-crowns-on-primary-molars-100587864",false,"NCT06933927","Comparative Evaluation of Gingival Health and Bacterial Adhesion in Bioflx vs. Zirconia Crowns on Primary Molars","Evaluation of Gingival Health and Bacterial Adhesion of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars: A Randomized Clinical Trial","Inclusion Criteria:\n\n1. patients aged 4-8 years.\n2. decayed in primary molars require full-coverage crowns.\n3. No history of systemic diseases affecting oral health.\n4. Cooperative children.\n\nExclusion Criteria:\n\n-patients with severe medical conditions, badly decayed in primary molars and trauma.","ALL","4 Years","8 Years",{"count":64,"type":65},28,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this clinical trial is to evaluate the Evaluation of Gingival Health and Bacterial Adhesion of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars of Bioflx crowns compared to zirconia crowns in the restoration of primary molars. The main question\\[s\\] it aims to answer is there are the differences in bacterial adhesion and gingival health between bioflx and zirconia crowns The study will also assess the clinical performance of both types of crowns in terms of bacterial adhesion , child and parents satisfaction,as well as preparation time.",[71],"Carious Primary Molars","NOT_YET_RECRUITING","2025-04-17",{"date":75,"type":76},"2025-04-22","ACTUAL",{"date":78,"type":65},"2025-06-01",{"date":80,"type":65},"2026-02-26",{"name":5,"class":6},1]