[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550670":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":28,"centralContacts":37,"locations":43,"responsibleParty":61,"collaborators":28,"id":65,"slug":28,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":28,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":28,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":46,"whyStopped":28,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,13,18],{"label":9,"type":6,"description":10,"interventionNames":11},"Group I Stainless steel crowns (control group)","It will include 17 molars that will be restored by a stainless steel crown.",[12],"Other: Preformed stainless steel crown.",{"label":14,"type":6,"description":15,"interventionNames":16},"Group II: Preformed zirconia crown (study group)","It will include 17 molars that will be restored by Zirconia crowns.",[17],"Other: Preformed zirconia crown",{"label":19,"type":6,"description":20,"interventionNames":21},"Group III: Preformed BioFlx crown (study group)","It will include 17 molars that will be restored by BioFlx crowns.",[22],"Other: Preformed BioFlx crown",[24,29,33],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Preformed stainless steel crown.","A well-fitted preformed stainless-steel crown will be chosen by measuring the mesiodistal dimension of the tooth or its contralateral counterpart, using a graduated periodontal probe for guidance. (6) Tooth preparation will be carried out with #835 diamond fissure bur to reduce occlusal surface up to 1 to 1.5 mm. The interproximal reduction will be made mesially and distally using #169 L tapered diamond bur around 0.5 mm to clear the contact area creating a feather edge finish line. The selected crown size will be checked, and a trial fit will be done before cementation. The crown will be cemented using self-cured RMGI luting cement. The excess will be removed, and proper occlusion will be checked.",[9],null,{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Preformed zirconia crown","The material for crown restoration for this group is the preformed zirconia crown. Tooth preparation will be started by occlusal reduction (1 to 1.5 mm) using #835 diamond fissure bur. The interproximal reduction will be done mesially and distally with #169 L tapered diamond bur in such a way that a straight probe passes freely through the contact area. Rounding of line angles will be done and a knife-edge finish margin of the proximal surface will be obtained avoiding any ledge formation. The selected crown will be placed and checked for a passive fit. Consistent firm finger pressure will be applied during cementation with self-cured RMGI luting cement. Finally, crown placement will be checked.",[14],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Preformed BioFlx crown","The prefabricated BioFlx crown will be used in this group. A similar-sized preformed crown will be selected. Tooth preparation will be carried out similarly to traditional SSCs with #835 diamond fissure bur for occlusal reduction by 1-1.5 mm including the central groove. The proximal preparation will be done mesially and distally with #169 L tapered diamond bur around 0.5 mm to clear the contact area creating a feather edge finish line. Placement of the crown will be achieved by a snug fit. Crown cementation will be carried out using self-cured RMGI luting cement and the excess cement will be removed using a floss or an explorer. (13) Finally, crown placement will be checked",[19],[38],{"name":39,"role":40,"phone":41,"phoneExt":28,"email":42},"Heba 0. Elbadry","CONTACT","+201116121999","Hebaaelbadry@mans.edu.eg",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Faculty of Dentistry, Mansoura University.","RECRUITING","Al Mansurah","Dakahlia Governorate","35516","Egypt",{"type":52,"coordinates":53},"Point",[54,55],31.38069,31.03637,{"lat":55,"lon":54},[58],{"name":59,"role":40,"phone":60,"phoneExt":28,"email":42},"Heba O Elbadry, B.D.S & M.D.S","+0201116121999",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Heba Elbadry","Assistant lecturer, peadiatric dentistry department","100550670",false,"NCT06450093","Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars","Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Children who are free from any systemic disease.\n* Children with a carious lower primary molar indicated for crown restoration.\n* Teeth with an intact antagonist and neighboring primary molar.\n* Cooperative children with scores 1 and 2 (positive or definitely positive) according to Frankl's behavior rating scale.\n\nExclusion Criteria:\n\n* Children with extremely poor oral hygiene.\n* Teeth showing radiographical furcation involvement or root resorption.\n* Children with para-functional habits, bruxism, or deep bite.\n* Teeth with inadequate non-restorable crown structure.",true,"ALL","4 Years","7 Years",{"count":76,"type":77},51,"ESTIMATED","INTERVENTIONAL",[80],"NA","This study will be conducted to:\n\nEvaluate and compare the clinical success, periodontal changes, and wear of antagonist teeth for three types of prefabricated crowns in primary molars: BioFlx crowns, Zirconia crowns, and Stainless Steel crowns.",[83],"Dental Restoration",[85,86,87,88,89],"Bioflx Crowns","Wear","Zirconia Crowns","stainless steel Crowns","periodontal changes","2024-06-06",{"date":92,"type":93},"2024-06-10","ACTUAL",{"date":95,"type":93},"2024-04-04",{"date":97,"type":77},"2026-06-01",{"name":5,"class":6},1]