[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611355":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":59,"collaborators":26,"id":63,"slug":26,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Fayoum University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Trinase group","EXPERIMENTAL","Patients receive one tablet of Trinase (trypsin, bromelain, and rutin) orally 30 minutes before single-visit root canal treatment (RCT). RCT is performed under local anesthesia (2% mepivacaine with 1:100,000 epinephrine), rubber dam isolation, using ProTaper Next rotary files up to X3, 2.5% NaOCl irrigation, EDTA gel, obturation with modified single-cone technique and Adseal resin sealer. Post-operative pain assessed via VAS at 6, 12, 24, 48 hours. Analgesic rescue (Trinase) allowed if needed; consumption recorded.",[13],"Drug: Trinase",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Patients receive one identical-appearing placebo tablet orally 30 minutes before identical single-visit RCT procedure (same anesthesia, instrumentation, irrigation, obturation protocol). Post-operative pain assessed via VAS at 6, 12, 24, 48 hours. Analgesic rescue (Trinase) allowed if needed; consumption recorded.",[19],"Drug: placebo capsule",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Trinase","One tablet of Trinase (proteolytic enzyme combination: trypsin, bromelain, and rutin) administered orally 30 minutes prior to root canal treatment. Used as premedication to reduce postoperative pain and inflammation.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"placebo capsule","One identical-appearing placebo tablet administered orally 30 minutes prior to root canal treatment. Used as control.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ahmed Maged Negm, Associate Professor","CONTACT","00201006600995","ahmed.maged@mgu.edu.eg",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Al Fayyum","Faiyum Governorate","12311","Egypt","EG",{"type":46,"coordinates":47},"Point",[48,49],30.8418,29.30995,{"lat":49,"lon":48},[52,55],{"name":53,"role":34,"phone":35,"phoneExt":26,"email":54},"Ahmed Negm, PhD","ahmed.maged@ngu.edu.eg",{"name":56,"role":34,"phone":57,"phoneExt":26,"email":58},"Sara El Mallah, PhD","00201000564987","sss07@fayoum.edu.eg",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Sara Elmallah","Associate professor of Endodontics","100611355",false,"NCT07239505","A Randomized Controlled Trial Evaluating Whether Pre-operative Trinase Reduces Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis Compared to Placebo, Using VAS Scores and Analgesic Intake Over 48 Hours.","The Role Of Trinase In Reducing Post-Operative Pain For Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Systemically healthy male patients (ASA I or II)\n* Aged 18 to 50 years\n* Presenting with symptomatic irreversible pulpitis in a restorable mandibular molar\n* Preoperative moderate to severe pain (VAS ≥45 mm)\n* Normal periapical tissue (no radiolucency, pocket depth ≤5 mm, mobility ≤ Grade I)\n\nExclusion Criteria:\n\nMedically compromised patients (ASA III or higher)\n\n* History of allergy or intolerance to Trinase or any of its components (trypsin, bromelain, rutin)\n* Vertical root fracture\n* External or internal root resorption\n* Periodontal pocket depth \\>5 mm\n* Tooth mobility Grade II or III\n* Presence of periapical lesion (radiolucency)\n* Female patients (to standardize pain perception and hormonal factors)","MALE","18 Years","50 Years",{"count":73,"type":74},182,"ESTIMATED","INTERVENTIONAL",[77],"NA","This study aims to determine whether Trinase, an enzyme-based anti-inflammatory medication, can reduce pain after root canal treatment in patients with symptomatic irreversible pulpitis. A total of 182 male patients aged 18 to 50 years who present with moderate to severe tooth pain will be randomly assigned to receive either a Trinase tablet or a placebo 30 minutes before treatment. All root canal procedures will be performed in a single visit using standard endodontic techniques.\n\nPain levels will be measured on a Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, and 48 hours after treatment. Patients will also record the number of pain-relief tablets they take during the first 48 hours. The goal of the study is to see whether Trinase can lower post-operative pain and reduce the need for analgesic medication compared with placebo. This information may help improve pain management for patients undergoing root canal therapy.",[80,81,82,83],"Symptomatic Irreversible Pulpitis (SIP)","Postoperative Pain After Endodontic Treatment","Endodontic Disease","Dental Pain",[85,86,23,87],"Visual Analogue Scale (VAS)","Randomized Controlled Trial","Postoperative Pain","2025-11-27",{"date":90,"type":91},"2025-12-01","ACTUAL",{"date":93,"type":91},"2025-08-01",{"date":95,"type":74},"2025-12-15",{"name":5,"class":6},1]