[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655278":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":32,"overallOfficials":40,"centralContacts":45,"locations":55,"responsibleParty":75,"collaborators":13,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":13,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":13,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":13,"overallStatus":58,"whyStopped":13,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Minia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Treatment of Postoperative Pain","Pain scores will be recorded on Visual Analog Scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain. Recording will be done everyday for 7 days period.","from 0 hours to 1 week after the procedure",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Root canal shaping represents a critical phase in endodontic treatment, as it facilitates effective cleaning and disinfection while preserving the original canal anatomy. The objective is to create a continuously tapered conical shape from coronal to apical regions without inducing procedural errors such as canal transportation, ledge formation, zipping, or perforation.\n\nWith advancements in nickel-titanium (NiTi) technology, modern rotary systems have been developed to enhance shaping efficiency, improve debris removal, and reduce preparation time. Recently, single-file rotary systems have gained popularity due to their simplified protocols, reduced instrument fatigue, and improved clinical efficiency.\n\nA novel concept in instrument design involves flat-sided rotary files manufactured from proprietary heat-treated NiTi alloys, such as AF One Blue and Platinum V.EU. These instruments exhibit a modified S-shaped cross-section with an inactive tip and a distinctive flat surface. The flat-sided design reduces the metal mass of the instrument, potentially enhancing flexibility, cyclic fatigue resistance,and facilitating coronal transportation of debris during instrumentation.\n\nIn contrast, One Curve is a single-file rotary system manufactured from heat treated C-wire alloy, which offers controlled memory properties, improved flexibility, and enhanced resistance to cyclic fatigue. It operates in continuous rotation and features a variable cross-sectional design that promotes efficient cutting while maintaining effective debris removal during canal preparation.\n\nApical extrusion of debris is an inevitable consequence of root canal instrumentation. The extrusion of dentinal debris, microorganisms, and irrigants beyond the apical foramen may induce an inflammatory response in the periapical tissues, which is considered a major contributing factor to postoperative pain. The amount of apically extruded debris has been shown to vary according to the design and kinematics of the instrumentation system used.\n\nDespite the continuous evolution in instrument design, there is limited evidence regarding the influence of flat-sided rotary systems compared to non-flat cross-sectional systems on apical debris extrusion and postoperative pain,particularly in curved canals. Furthermore, the potential relationship between debris extrusion and the severity of postoperative pain remains insufficiently explored.",[22,28],{"label":23,"type":24,"description":25,"interventionNames":26},"one curve file","ACTIVE_COMPARATOR","About 15 cases will be subjected to one single file to the full working length. File will be operated at 300 rpm\u002F2.5 Ncm torque in continuous rotation",[27],"Procedure: AF One single-file rotary system",{"label":29,"type":24,"description":30,"interventionNames":31},"AF Fanta flat sided file system","About 15 cases will be subjected to one single file to the full working length.File will be operated at 300 rpm\u002F2.5 Ncm torque in continuous rotation",[27],[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"PROCEDURE","AF One single-file rotary system","to evaluate and compare the amount of apically extruded debris using the AF One single-file rotary system, featuring a flat-sided design, and the One Curve rotary system in curved mesiobuccal canals of mandibular first molars. Additionally, this study aims to assess postoperative pain associated with both systems and to investigate the potential correlation between apical debris extrusion and postoperative pain.",[29,23],[39],"One Curve rotary system",[41],{"name":42,"affiliation":43,"role":44},"Maged Mohamed Negm, Professor","Endodontics Department, Faculty of Dentistry, Cairo University","STUDY_CHAIR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":13,"email":50},"Nahla Nasr El-Din Fouad Mohamed, MSC","CONTACT","+201009067349","nannanasr248@gmail.com",{"name":52,"role":48,"phone":53,"phoneExt":13,"email":54},"Dalia Ali Mokarab, M.D","+201068121523","dalia.mokarab@mu.edu.eg",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":13,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Endodontics, Faculty of Dentistry, Minia University","RECRUITING","Minya","Minya Governorate","Egypt","EG",{"type":64,"coordinates":65},"Point",[66,67],30.75813,28.09193,{"lat":67,"lon":66},[70,71],{"name":52,"role":48,"phone":53,"phoneExt":13,"email":54},{"name":72,"role":48,"phone":73,"phoneExt":13,"email":74},"Ahmed Ali Yossef, M.D","+201007335293","ahmed.yousef@mu.edu.eg",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Nahla Nasr El-Din Fouad","Assistant lecturer at Endodontics Department,Faculty of Dentistry","100655278","impact-of-cross-sectional-design-in-single-file-rotary-system-on-apical-debris-extrusion-100655278",false,"NCT07808684","Impact of Cross-Sectional Design in Single-File Rotary System on Apical Debris Extrusion","Impact of Cross-Sectional Design in Single-File Rotary System on Apical Debris Extrusion and Postoperative Pain Following Single-Visit Root Canal Treatment: An In Vitro and Randomized Clinical Study","Inclusion Criteria:\n\n* Teeth with mature apex\n* Straight root canal or mild curvature not exceeding(5-10) Schneider.\n* Has intact crown ( coronal structure)\n* Presence of one orifices and one apices, patency achieved by a #10-15 K-file to the apical foramen\n\nExclusion Criteria:\n\n* Previous root canal treatment.\n* Internal\u002Fexternal resorption.\n* Immature root apices.\n* Caries\u002Fcracks\u002Ffractures on the root surface.\n* Root canal curvature more than 10 degrees.\n* Teeth in which the apical minor constriction was gauged larger than a size 20 hand file.","ALL","20 Years","40 Years",{"count":90,"type":91},30,"ESTIMATED","INTERVENTIONAL",[94],"NA","Endodontic treatment aims to achieve optimal biological outcomes while minimizing patient's discomfort during and after the procedure. Postoperative pain remains a common complication and is considered a multifactorial phenomenon influenced by several factors, including preoperative pain, age, gender, systemic health, presence of apical periodontitis, instrumentation technique, type and design of endodontic instruments, and the use of intracanal medications.",[97,98],"Postoperative Pain","Irreversible Pulpitis","2026-09-02",{"date":101,"type":102},"2026-09-09","ACTUAL",{"date":104,"type":102},"2026-06-01",{"date":106,"type":91},"2026-12-30",{"name":5,"class":6},1]