[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653538":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":31,"studyPopulation":22,"armGroups":32,"interventions":45,"overallOfficials":22,"centralContacts":55,"locations":61,"responsibleParty":72,"collaborators":22,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":22,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":22,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":99,"whyStopped":22,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Tanta University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Occlusal Bite Force Distribution","The percentage of total occlusal force (%) distributed on the restored primary molar will be measured using a digital occlusal analysis system. The closure demonstrating the maximum recorded occlusal force will be selected for analysis.","Baseline (before crown placement), immediately after crown cementation, one and three months after treatment.",[14,18],{"measure":15,"description":16,"timeFrame":17},"Masseter Muscle Activity","Bilateral masseter muscle activity, expressed as integrated mean electromyographic activity (µV or µV·s, according to the recording output), will be measured using surface electromyography (sEMG) during the rest position and maximum voluntary clenching.","Baseline (before crown placement), immediately after crown cementation, one month and three months after treatment.",{"measure":19,"description":20,"timeFrame":21},"Occlusal Contacts","The number and distribution of occlusal contacts, including the presence or absence of premature occlusal contacts (number of patients\u002Fteeth with premature contacts), will be assessed using digital intraoral scanning and digital occlusal analysis.","Baseline, immediately after crown placement, and 1 and 3 month after treatment.",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":29},"SINGLE",[30],"OUTCOMES_ASSESSOR","This controlled, randomized clinical trial aims to compare the recovery of occlusal function following restoration of primary molars with preformed BioFlx crowns and stainless steel crowns in children aged 5-8 years. thirty eligible children requiring full-coverage crown restorations of primary molars will be randomly allocated to receive either a BioFlx crown or a stainless steel crown. Occlusal bite force, occlusal contact distribution, vertical dimension, and masseter muscle activity assessed by surface electromyography will be evaluated before treatment, immediately after crown placement, and during follow-up. Clinical evaluations will also be performed at 1and 3 months.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"BioFlx Crown Group","EXPERIMENTAL","Participants will receive preformed BioFlx full-coverage crowns for restoration of eligible primary molars.",[38],"Procedure: Preformed BioFlx Crown",{"label":40,"type":41,"description":42,"interventionNames":43},"Stainless Steel Crown Group","ACTIVE_COMPARATOR","Participants will receive preformed stainless steel full-coverage crowns for restoration of eligible primary molars.",[44],"Procedure: Preformed Stainless Steel Crown",[46,51],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":22},"PROCEDURE","Preformed BioFlx Crown","Eligible primary molars will be restored with appropriately sized BioFlx crowns following tooth preparation according to the manufacturer's recommendations. The crowns will be adjusted as needed, cemented using glass ionomer cement, and final occlusion will be verified.",[34],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":22},"Preformed Stainless Steel Crown","Eligible primary molars will be prepared according to standard clinical procedures, fitted with an appropriately sized crown, adjusted and contoured as required, cemented using glass ionomer cement, and final occlusion will be verified.",[40],[56],{"name":57,"role":58,"phone":59,"phoneExt":22,"email":60},"shaimaa eldesouky, assistant professor","CONTACT","01008994242","shaimaaeldesouky@dent.tanta.edu.eg",[62],{"facility":63,"status":22,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":22,"geoPoint":22,"contacts":69},"faculty of dentistry, Tanta university","Tanta","Cairo Governorate","31527","Egypt","EG",[70],{"name":71,"role":58,"phone":59,"phoneExt":22,"email":60},"shaimaa eldesouky",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Shaimaa Shaban Mohamed El-desouky","assistant professor of pediatric dentistry","100653538","bite-force-recovery-following-pediatric-full-crown-restorations-100653538",false,"NCT07786805","Bite Force Recovery Following Pediatric Full Crown Restorations","Bite Force Recovery Following Pediatric Full Crown Restorations: A Comparative Study of Bioflx and Stainless-steel Crowns","Inclusion Criteria:\n\n* Children aged 5-8 years.\n* Healthy and cooperative children who are able to tolerate the required dental procedures and follow-up visits.\n* Children requiring full-coverage crown restoration of a primary molar due to extensive or multisurface caries, wide proximal carious lesions\n* Primary molars requiring pulp therapy followed by full-coverage restoration.\n* Primary molars with more than one-third of the root structure remaining radiographically.\n* Children with normal molar relationship.\n* Children with normal overjet and overbite.\n* Children without clinically evident malocclusion.\n* Children without parafunctional oral habits.\n\nExclusion Criteria:\n\n* Temporomandibular joint disorders\n* Apparent facial asymmetry.\n* Uncontrolled systemic disease or medical condition that may affect participation in the study or the dental treatment.\n* Current or previous orthodontic treatment that may influence occlusion or bite-force measurements.\n* Presence of parafunctional habits, such as bruxism or other abnormal occlusal habits.","ALL","5 Years","8 Years",{"count":87,"type":88},30,"ESTIMATED","INTERVENTIONAL",[91],"NA","A component of masticatory function is bite force. Dental caries is one factor that contributes to poor dental health, which has an overall negative influence on quality of life. Caries has a detrimental after effect of functional impairment. this study aims to evaluate how children occlusal bite forces are affected by complete dental care. thirty children with dental caries in their primary molars, ages 5 to 8, of both sexes will be included. Occlusal force gauge was used to measure the occlusal bite force in the vicinity of primary molars both before and after restorations. A statistical analysis was performed on the collected data",[94,95,96],"Bite Force","Stainless-steel Crown","Masseter Muscle",[98],"bite force, dental caries, restoration, Bioflx crown, Stainless steel crowns","NOT_YET_RECRUITING","2026-08-26",{"date":102,"type":103},"2026-08-31","ACTUAL",{"date":105,"type":88},"2026-09",{"date":107,"type":88},"2026-12",{"name":5,"class":6},1]