[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644806":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":39,"collaborators":25,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":25,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":25,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":70,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":25},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pediatric NiTi rotary files manufactured with AF-H Wire technology","ACTIVE_COMPARATOR","Pediatric NiTi rotary files manufactured with AF-H Wire technology are designed to improve flexibility and cyclic fatigue resistance while facilitating efficient canal preparation. Clinical studies have reported significantly reduced instrumentation time using this rotary system compared with conventional hand instrumentation. Furthermore, the system has demonstrated favorable canal shaping ability and a high percentage of optimally obturated canals, indicating its effectiveness in pediatric pulpectomy procedures",[13],"Device: Pediatric NiTi rotary files manufactured with AF-H Wire technology",{"label":15,"type":16,"description":17,"interventionNames":18},"Pediatric NiTi rotary files manufactured with blue wire technology","EXPERIMENTAL","Pediatric NiTi rotary files manufactured with blue wire technology are a newer pediatric rotary system developed using blue heat-treated NiTi technology. Heat treatment enhances flexibility, resistance to cyclic fatigue, and fracture resistance, which are important characteristics when preparing the curved canals of primary teeth. Laboratory studies have shown that blue wire pediatric rotary files exhibit excellent mechanical properties and superior cyclic fatigue resistance compared with several other pediatric rotary systems. However, clinical evidence evaluating its performance in terms of instrumentation efficiency and obturation quality remains limited.",[19],"Device: Pediatric NiTi rotary files manufactured with blue wire technology",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using pediatric NiTi rotary files manufactured with AF-H Wire technology with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex and zinc oxide eugenol, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using blue technology wire rotary files with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.",[15],[30],{"name":31,"affiliation":5,"role":32},"Sara A. Mahmoud, Professor","STUDY_DIRECTOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Rania F. Mohamed, bachelor","CONTACT","+01000416751","rania.fathy@dentistry.cu.edu.eg",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Rania Fathy Mohammed Mohammed","principal investigator","100644806","evaluation-of-instrumentation-time-and-obturation-quality-using-two-different-pediatric-rotary-file-systems-in-primary-molar-pulpectomy-100644806",false,"NCT07672990","Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy","Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy :(A Randomized Clinical Trial)","Inclusion Criteria:\n\n1. Healthy Cooperative children.\n2. Children between the ages of four and eight years.\n3. Restorable teeth with irreversible pulpitis.\n4. Continuous bleeding after amputation of coronal pulp tissue.\n\nExclusion Criteria:\n\n1. Molars that exhibit physiologic root resorption in excess of one-third.\n2. Internal and external root resorption.\n3. Presence of dental abscess, sinus tract or excessive mobility.\n4. Acute spreading infection\u002Fcellulitis not manageable with local treatment.\n5. Large periapical\u002Ffurcation lesion with poor prognosis.\n6. Teeth close to natural exfoliation.\n7. Children with known allergies to study materials or medications used.",true,"ALL","4 Years","8 Years",{"count":55,"type":56},30,"ESTIMATED","INTERVENTIONAL",[59],"NA","Preserving primary teeth is essential for maintaining normal chewing, speech development, and psychological well-being. Successful pulpectomy depends on effective chemomechanical preparation of the root canals while preserving their original anatomy. Although hand files are traditionally used for canal preparation in primary teeth, they are time-consuming and may increase the risk of procedural errors. Nickel-titanium (Ni-Ti) rotary systems have gained popularity because they improve canal shaping and reduce instrumentation time. Among these systems, Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue Wire technology are specifically designed for pediatric use. However, evidence regarding their clinical performance remains limited, highlighting the need to compare their effectiveness, particularly in terms of instrumentation time and obturation quality",[62],"Pulpectomy",[64,65,66,67,68,69],"EndoArt Pedo Blue","fanta Baby","instrumentation time","obturation quality","pulpectomy using rotary files","rotary files in primary molars","NOT_YET_RECRUITING","2026-06-28",{"date":73,"type":74},"2026-07-01","ACTUAL",{"date":76,"type":56},"2026-09",{"date":78,"type":56},"2027-09",{"name":5,"class":6}]