[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642280":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":51,"centralContacts":58,"locations":67,"responsibleParty":92,"collaborators":26,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":26,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":26,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Eskisehir Osmangazi University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"ONE RECI 25\u002F06 Reciprocating file","EXPERIMENTAL","Produced in 2016, the One Reci (Micro Mega, France) is a system used in routine dental treatments that offers single-file use with a reciprocating motion. The OR system undergoes a special heat treatment (C-wire) to increase the flexibility of the file and ensure better centering within the canal. Its variable off-center cross-section profile starts with a triple helix and transforms into an S-shape toward the shank, creating a deep groove that allows more effective removal of debris from the coronal region. This feature provides the file with high cutting efficiency. The system completes its cutting motion by rotating 170 degrees counterclockwise and 60 degrees clockwise. The files in this system are available in sizes 20.04, 25.04, 25.06, 35.04, and 45.04. Thanks to this design, the OR system helps preserve the original canal anatomy by minimizing dentin loss, especially in narrow and curved root canals.",[13],"Device: Reciprocating NiTi file system",{"label":15,"type":10,"description":16,"interventionNames":17},"FKG RACE EVO 25\u002F06 Rotation files","The Race EVO (FKG Dentaire SA, Switzerland), a single-file system used with rotational motion, was first produced in 2010 and is a file system routinely used in dental treatments. It stands out as a new-generation rotary file system with optimized cutting efficiency, low torsional effect, and high cyclic fatigue resistance. Its triangular cross-section and alternating cutting edge design reduce the screwing effect, allowing safe progression in the canal. The files are available in 4% and 6% taper options and are used at 800-1000 rpm with 1.5 Ncm torque. The rounded safety tip and electrochemically polished surface reduce the risk of fracture and increase surface smoothness. With these features, Race EVO is described in the literature as a fast, safe, and effective option among modern NiTi rotary systems (Mustafa, 2021). Additionally, comparative studies have shown that Race EVO significantly reduces canal transportation and unnecessary dentin removal compared to systems such as ProTap",[18],"Device: Rotary NiTi file system",{"label":20,"type":10,"description":21,"interventionNames":22},"FKG RACE EVO 25\u002F06 Rotation files + Xp Endo Finisher","XP-Endo Finisher is a modern instrument that contributes to the removal of debris, smear layer, and microorganisms remaining in difficult-to-reach areas of root canals. Owing to its thermomechanical properties, it can undergo a phase transformation at body temperature, expand, and adapt to the canal anatomy, thereby establishing more effective contact with dentin surfaces. This adaptive behavior facilitates a more homogeneous distribution of irrigation solutions across canal surfaces and enhances irrigation effectiveness compared with conventional methods. With all these features, XP-Endo Finisher is considered an innovative and complementary tool that improves the effectiveness of irrigation in endodontic treatments.",[23],"Device: Rotary NiTi file system with irrigation activation device",{"label":25,"type":10,"description":26,"interventionNames":27},"ONE RECI 25\u002F06 Reciprocating file + Xp Endo Finisher",null,[28],"Device: Reciprocating NiTi file system with irrigation activation device",[30,37,43,47],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DEVICE","Rotary NiTi file system","In this intervention, root canal shaping in mandibular molars with chronic apical periodontitis or periapical radiolucency will be performed using the rotary NiTi file system FKG Race Evo 25\u002F06. The procedure will be conducted under rubber dam isolation according to standard endodontic protocols and irrigation procedures. Postoperative pain will be evaluated using the Visual Analog Scale (VAS).",[15],[36],"FKG Race Evo 25\u002F06 Race Evo",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Rotary NiTi file system with irrigation activation device","Root canal shaping will be performed using the rotary NiTi file system FKG Race Evo 25\u002F06, followed by irrigation activation with the XP-Endo Finisher. The XP-Endo Finisher will be operated at 800 rpm and 1 Ncm torque to enhance irrigation efficacy. Postoperative pain and analgesic use will be monitored.",[20],[42],"FKG Race Evo 25\u002F06 XP-Endo Finisher Race Evo with XP-Endo Finisher",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":26},"Reciprocating NiTi file system","Root canal shaping in mandibular molars with chronic apical periodontitis or periapical radiolucency will be performed using the reciprocating NiTi file system One Reci 25\u002F06. The procedure will be conducted under rubber dam isolation following standard endodontic protocols. Postoperative pain will be recorded at predefined time points using the Visual Analog Scale (VAS).",[9],{"type":31,"name":48,"description":49,"armGroupLabels":50,"otherNames":26},"Reciprocating NiTi file system with irrigation activation device","Root canal shaping will be performed using the reciprocating NiTi file system One Reci 25\u002F06, followed by irrigation activation with the XP-Endo Finisher. The XP-Endo Finisher enhances the distribution of irrigants in the canal system. Postoperative pain levels and analgesic consumption will be evaluated across the groups.",[25],[52,55],{"name":53,"affiliation":5,"role":54},"Betül Güneş, Associate Professor","STUDY_DIRECTOR",{"name":56,"affiliation":5,"role":57},"Büşra Öztürk","PRINCIPAL_INVESTIGATOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":26,"email":63},"Büşra Öztürk, Research Assistant","CONTACT","+905546810288","oztrkbusra95@gmail.com",{"name":53,"role":61,"phone":65,"phoneExt":26,"email":66},"05052667501","bgunes@ogu.edu.tr",[68,88],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":26,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Eskişehir Osmangazi University","RECRUITING","Eskişehir","Odunpazarı","26040","Turkey (Türkiye)",{"type":76,"coordinates":77},"Point",[78,79],30.52056,39.77667,{"lat":79,"lon":78},[82,86],{"name":83,"role":61,"phone":84,"phoneExt":26,"email":85},"Büşra Öztürk, Research Asistant","05546810288","busrao.ozturk@ogu.edu.tr",{"name":53,"role":61,"phone":87,"phoneExt":26,"email":66},"5052667501",{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":26,"cosmosGeoPoint":89,"geoPoint":91,"contacts":26},{"type":76,"coordinates":90},[78,79],{"lat":79,"lon":78},{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","BUSRA OZTURK","Research Assistant","100642280","effect-of-niti-systems-and-xp-endo-finisher-on-postoperative-pain-100642280",false,"NCT07642596","EFFECT OF NITI SYSTEMS AND XP-ENDO FINISHER ON POSTOPERATIVE PAIN","EVALUATION OF THE EFFECT OF RECIPROCATING AND ROTARY NICKEL-TITANIUM FILE SYSTEMS USED IN COMBINATION WITH XP-ENDO FINISHER ON POSTOPERATIVE PAIN FOLLOWING ROOT CANAL TREATMENT","Inclusion Criteria:\n\n* Age 18-65 years. Healthy volunteers. Mandibular molar teeth with pulpal necrosis, asymptomatic status, chronic apical periodontitis, and periapical radiolucent lesion.\n\nWritten informed consent.\n\nExclusion Criteria:\n\n* Patients who have taken analgesic or anti-inflammatory drugs within the last 12 hours.\n\nPatients with allergy to non-steroidal anti-inflammatory drugs or local anesthetics.\n\nPregnant or lactating patients. Patients with a history of gastrointestinal diseases. Patients using opioid medications. Teeth with calcified canals, resorptive defects, or complex root canal anatomy. Patients with severe periodontal disease. Patients with acute or chronic apical abscess or signs of systemic infection. Immunosuppressed patients.",true,"ALL","18 Years","65 Years",{"count":108,"type":109},80,"ESTIMATED","INTERVENTIONAL",[112],"NA","Title\n\nEvaluation of the Effect of Reciprocal and Rotational NiTi File Systems and XP-Endo Finisher Combination on Postoperative Pain\n\nClinical Research Protocol Summary Objective\n\nThe aim of this study is to compare the effects of different NiTi file systems (FKG Race Evo and One Reci) and their combination with XP-Endo Finisher on postoperative pain. The study intends to evaluate how these two different file systems and XP-Endo Finisher influence patients' pain levels after endodontic treatment. It is also hypothesized that XP-Endo Finisher may play an important role in reducing postoperative pain by enhancing irrigation efficacy. This study is expected to contribute clinically significant findings to the limited literature on this topic.\n\nBackground\n\nEndodontic treatment is a procedure performed to mechanically shape, disinfect, and hermetically seal teeth with pulpal damage or periapical lesions caused by caries or trauma. The success of treatment depends on proper shaping within biological limits, effective disinfection, preservation of apical constriction, and removal of bacteria from canal walls.\n\nNiTi alloys have improved canal shaping efficiency due to their flexibility and shape memory properties. Rotary and reciprocating NiTi systems each offer different clinical advantages. Rotary systems provide efficient shaping through continuous rotation, while reciprocating systems offer a minimally invasive approach using a single file.\n\nPostoperative pain is a common complication after endodontic treatment and may vary depending on instrumentation technique, irrigation protocol, and clinical conditions.\n\nIrrigation is essential for removing microorganisms and debris from the canal system. Conventional irrigation techniques may be insufficient to reach apical areas effectively. Therefore, advanced systems such as XP-Endo Finisher have been developed to improve irrigant penetration and enhance cleaning efficiency.\n\nFKG Race Evo is a rotary NiTi system with high cyclic fatigue resistance, while One Reci is a reciprocating single-file system that offers safe shaping with reduced procedural errors. This study will evaluate the postoperative pain outcomes of these systems in combination with XP-Endo Finisher.\n\nMaterials and Methods\n\nThe materials used in this study include FKG Race Evo and One Reci NiTi file systems, XP-Endo Finisher, 2.5% sodium hypochlorite (NaOCl), 17% EDTA, and saline solution.\n\nThe study will be conducted on 80 patients attending the Department of Endodontics, Faculty of Dentistry, Eskisehir Osmangazi University. Healthy individuals aged 18-65 years with chronic apical periodontitis or periapical radiolucent lesions will be included. Written informed consent will be obtained from all participants.\n\nPatients will be randomly divided into four groups:\n\nGroup 1: Instrumentation with FKG Race Evo 25\u002F06 Group 2: FKG Race Evo 25\u002F06 followed by XP-Endo Finisher irrigation Group 3: Instrumentation with One Reci 25\u002F06 Group 4: One Reci 25\u002F06 followed by XP-Endo Finisher irrigation\n\nAll procedures will be performed under rubber dam isolation and local anesthesia. Canal shaping will be performed according to the assigned system, with irrigation performed after each file change. Obturation will be completed in the second session.\n\nSample Size Calculation\n\nThe sample size was calculated using G\\*Power software (3.1.9.4; Heinrich Heine University, Düsseldorf, Germany). The calculation was based on a 5% type I error (alpha), 95% power (1-β), and an effect size of 0.587 (f), derived from a previous study. A total of 80 participants was determined to be sufficient to detect statistically significant differences between groups. Each group will include 20 patients.\n\nStatistical Analysis\n\nAll data will be recorded electronically with strict confidentiality. Only authorized researchers will have access to the dataset.\n\nStatistical analysis will be performed using appropriate software. The choice of statistical tests will depend on data distribution.\n\nStudy results may be published in national or international peer-reviewed journals in accordance with ethical and legal requirements. All data will be anonymized to protect participant confidentiality, and secure electronic storage will be used to prevent unauthorized access.",[115],"Postoperative Pain After Endodontic Treatment",[117],"Postoperative pain NiTi rotary files NiTi reciprocating files FKG Race Evo One Reci XP-Endo Finisher","2026-06-10",{"date":120,"type":121},"2026-06-11","ACTUAL",{"date":123,"type":121},"2026-02-13",{"date":125,"type":109},"2027-04-30",{"name":94,"class":6},2]