[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634983":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":52,"centralContacts":61,"locations":67,"responsibleParty":86,"collaborators":47,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":47,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":47,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":125,"whyStopped":47,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Suez Canal University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Ultrasonic Activation","EXPERIMENTAL","Root canals will be irrigated with sodium hypochlorite (NaOCl) activated using an ultrasonic device (Ultramint with R17 tip).",[13],"Procedure: Ultrasonic Irrigation Activation",{"label":15,"type":10,"description":16,"interventionNames":17},"ARM 2: Laser Activation","Root canals will be irrigated with NaOCl activated using a diode laser device (Elexxon Pico, Germany) with methylene blue (0.1 mg\u002FmL) as a photosensitizer to enhance antimicrobial effects.",[18],"Procedure: Laser-Activated Irrigation",{"label":20,"type":10,"description":21,"interventionNames":22},"ARM 3: Mechanical Activation (Easy Clean)","Root canals will be irrigated with NaOCl, activated mechanically using the Easy Clean device (BassiEndo) to create a swirling motion for improved disinfection.",[23],"Procedure: Mechanical Irrigation Activation",{"label":25,"type":10,"description":26,"interventionNames":27},"ARM 4: Negative Pressure Irrigation (PulpSucker)","Root canals will be irrigated with NaOCl using the PulpSucker device (PlanB dental), which employs negative pressure irrigation to ensure continuous delivery and debris removal.",[28],"Procedure: Negative Pressure Irrigation",[30,37,43,48],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"PROCEDURE","Ultrasonic Irrigation Activation","Sodium hypochlorite irrigation activated with ultrasonic device",[9],[36],"Group-I",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Laser-Activated Irrigation","Laser-activated sodium hypochlorite with methylene blue photosensitizer",[15],[42],"Group-II",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Mechanical Irrigation Activation","Mechanical activation device creating swirling motion",[20],null,{"type":31,"name":49,"description":50,"armGroupLabels":51,"otherNames":47},"Negative Pressure Irrigation","Continuous irrigation with negative pressure suction",[25],[53,57],{"name":54,"affiliation":55,"role":56},"Salah El-Din Mohamed Abdallah, Professor, PhD","Professor of Microbiology, Faculty of Pharmacy, Suez Canal University","STUDY_DIRECTOR",{"name":58,"affiliation":59,"role":60},"Hayam Youssef Hassan, Professor, PhD","Professor of Endodontics, Faculty of Dentistry, Suez Canal University","STUDY_CHAIR",[62],{"name":63,"role":64,"phone":65,"phoneExt":47,"email":66},"Salma Mohamed Hassan Gohar, MSc","CONTACT","0020 1157445565","Salma_gohar@dent.suez.edu.eg",[68],{"facility":69,"status":47,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Endodontic Clinic, Faculty of Dentistry, Suez Canal University","Ismailia","Ismailia Governorate","41522","Egypt","EG",{"type":76,"coordinates":77},"Point",[78,79],32.27225,30.60427,{"lat":79,"lon":78},[82,84],{"name":63,"role":64,"phone":83,"phoneExt":47,"email":66},"00201157445565",{"name":58,"role":64,"phone":85,"phoneExt":47,"email":47},"+20 1227609611",{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"PRINCIPAL_INVESTIGATOR","Salma gohar","Assistant Lecturer, Department of Endodontics","100634983","metagenomic-analysis-and-postoperative-pain-in-infected-root-canals-using-different-irrigation-protocols-100634983",false,"NCT07546773","Metagenomic Analysis and Postoperative Pain in Infected Root Canals Using Different Irrigation Protocols","Metagenomic Analysis and Post-operative Pain Assessment of Infected Root Canals Using Different Irrigation Protocols: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Adult patients aged 18-60 years\n* Requiring root canal treatment for teeth with necrotic pulp\n* Presence of periapical radiolucency confirmed radiographically\n* Good general health with no systemic diseases affecting healing outcomes\n* Willing to provide informed written consent\n* Available for follow-up appointments\n\nExclusion Criteria:\n\n* Patients with open apices\n* Severe periodontal disease\n* Currently taking antibiotics\n* Allergy to study materials (lidocaine, sodium hypochlorite, methylene blue, latex)\n* Pregnant or breastfeeding women\n* Compromised immunity or systemic conditions (e.g., uncontrolled diabetes, HIV, immunosuppressive therapy)\n* Previous root canal treatment on the study tooth\n* Tooth not restorable\n* Presence of vertical root fracture","ALL","18 Years","60 Years",{"count":101,"type":102},40,"ESTIMATED","INTERVENTIONAL",[105],"NA","Achieving effective root canal disinfection while minimizing postoperative pain is a critical goal in endodontic therapy. Advanced irrigation protocols, such as ultrasonic activation, laser activation, negative pressure irrigation (PulpSucker device), and mechanical activation (Easy Clean device), have shown promise in enhancing bacterial reduction within the root canal system. However, their impact on postoperative pain has not been fully explored.\n\nThis randomized controlled clinical trial aims to compare bacterial reduction and postoperative pain levels in infected root canals using four different irrigation protocols. The study will use metagenomic analysis to evaluate changes in bacterial community composition and the Visual Analogue Scale (VAS) to assess patient-reported pain levels at multiple time points postoperatively.",[108,109],"Dental Pulp Necrosis","Pulpitis",[111,112,113,114,115,116,117,118,119,120,121,122,123,124],"Root canal treatment","Irrigation protocol","Ultrasonic activation","Laser activation","Negative pressure irrigation","Mechanical activation","Metagenomic analysis","Postoperative pain","Visual analogue scale","Bacterial reduction","Endodontics","PulpSucker","Easy clean device","Next generation sequencing","NOT_YET_RECRUITING","2026-04-28",{"date":128,"type":129},"2026-05-04","ACTUAL",{"date":131,"type":102},"2026-04-30",{"date":133,"type":102},"2028-01-15",{"name":5,"class":6},1]