[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631723":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":47,"locations":11,"responsibleParty":53,"collaborators":11,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":11},{"fullName":5,"class":6},"Al-Azhar University","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Cention N","EXPERIMENTAL",null,[13],"Device: Cention N",{"label":15,"type":10,"description":11,"interventionNames":16},"Group B: Stela (Self-cure Bulk-fill Composite)",[17],"Device: Stela, SDI, Australia",{"label":19,"type":20,"description":11,"interventionNames":21},"Group C: Beautifil II (Nanohybrid Composite)","ACTIVE_COMPARATOR",[22],"Device: Beautifil II, Shofu, Japan",{"label":24,"type":20,"description":11,"interventionNames":25},"Group D: Riva Light Cure (RMGIC)",[26],"Device: Resin modified glass ionomer cement",[28,35,39,43],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DEVICE","Cention N","Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions.",[9],[34],"Ivoclar Vivadent",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Stela, SDI, Australia","Self-cure bulk-fill resin composite (Stela; SDI) used for direct restoration of carious primary molars according to the manufacturer's instructions.",[15],{"type":29,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"Beautifil II, Shofu, Japan","Light-cured nanohybrid resin composite (Beautifil II) used for direct restoration of carious primary molars according to the manufacturer's instructions.",[19],{"type":29,"name":44,"description":45,"armGroupLabels":46,"otherNames":11},"Resin modified glass ionomer cement","Resin-modified glass ionomer cement (Riva Light Cure) used for direct restoration of carious primary molars according to the manufacturer's instructions.",[24],[48],{"name":49,"role":50,"phone":51,"phoneExt":11,"email":52},"Hosam Hassan Metwalli","CONTACT","+201147957878","dr.hosamhassan2@gmail.com",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Hosam Hassan","principal investigator","100631723","clinical-performance-of-four-restorative-materials-in-primary-molars-100631723",false,"NCT07504393","Clinical Performance of Four Restorative Materials in Primary Molars","Clinical Evaluation of an Alkasite Restoration Material (Cention N) and Self-cure Composite (Stela; SDI) Compared to Conventional Composite and Resin-modified Glass Ionomer in Primary Molars: A Randomized Clinical Trial","Inclusion Criteria:\n\n1. Age 4-8 years old.\n2. Primary molars indicated for restorative treatment.\n3. No pulp involvement or history of dental pain.\n4. Cooperative children (Frankl: +ve or ++ve).\n\nExclusion Criteria:\n\n1. Pulp exposure after caries removal or clinical signs of irreversible pulpitis\u002Fnecrosis.\n2. Severe developmental enamel defects or insufficient enamel for bonding.","ALL","4 Years","8 Years",{"count":68,"type":69},92,"ESTIMATED","INTERVENTIONAL",[72],"NA","This randomized clinical trial aims to compare the clinical and radiographic performance of four direct restorative materials used for restoring carious primary molars in children. Eligible children aged 4-8 years with posterior primary molars requiring direct restoration will be randomly allocated (1:1:1:1) to receive one of the following materials: an alkasite restorative material (Cention N), a self-cure bulk-fill resin composite (Stela; SDI), a conventional light-cured nanohybrid resin composite (Beautifil II), or a resin-modified glass ionomer cement (Riva Light Cure). Restorations will be evaluated using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria. Postoperative sensitivity will be assessed at 48 hours using a 0-10 visual analogue scale (VAS). Clinical and radiographic follow-up assessments will be conducted at baseline and at scheduled recall visits",[75,76],"Dental Caries","Primary Molars",[78,79,80,81,30,82,83,84],"stela","Primary molars","Pediatric dentistry","Direct restoration","Nanohybrid composite","Resin-modified glass ionomer","FDI criteria","NOT_YET_RECRUITING","2026-03-27",{"date":88,"type":89},"2026-03-31","ACTUAL",{"date":91,"type":69},"2026-04-01",{"date":93,"type":69},"2026-11",{"name":5,"class":6}]