[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645510":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":24,"responsibleParty":35,"collaborators":24,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":24,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":24,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":24},{"fullName":5,"class":6},"Cairo University","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Normal Saline 0.09","Isotonic, biologically inert final irrigant; mechanical debridement only, no pharmacological activity.",[12],"Drug: Normal (0.9%) saline",{"label":14,"type":15,"description":10,"interventionNames":16},"Hypertonic Saline 3%","EXPERIMENTAL",[17],"Drug: Hypertonic 3% saline",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Normal (0.9%) saline","Isotonic 0.9% NaCl solution used as final canal flush, no pharmacological activity",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Hypertonic 3% saline","Osmotic\u002Fanti-inflammatory final irrigant hypothesized to reduce periapical edema and suppress pro-inflammatory cytokine-mediated SP release via NF-κB pathway inhibition.",[14],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Kariman Ameen Ismaiel","CONTACT","+201013665586","kariman.ameen@dentistry.cu.edu.eg",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Kariman Mohammed Mohammed Amin Ismaiel","PhD Candidate","100645510","phase-4-hypertonic-saline-as-a-final-flush-and-post-operative-pain-after-single-visit-root-canal-treatment-in-mandibular-premolar-100645510",false,"NCT07701551","Hypertonic Saline as a Final Flush and Post-Operative Pain After Single Visit Root Canal Treatment in Mandibular Premolar.","Effect of Hypertonic Saline (3%) as a Final Flush Irrigant on Post-Operative Pain and Substance P Expression Following Single-Visit Root Canal Treatment in Patients With Symptomatic Irreversible Pulpitis Related to Mandibular Premolars: A Randomized Controlled Trial","Hypertonic","Inclusion Criteria:\n\n* Age 18-60 years, any sex\n* Systemically healthy\n* Mandibular premolar with clinically\u002Fradiographically diagnosed symptomatic irreversible pulpitis (prolonged, exaggerated response to cold testing; no periapical radiolucency)\n* Able to use the VAS scale and complete follow-up\n\nExclusion Criteria:\n\n* Medically compromised patients\n* Pregnant or lactating women\n* Allergy\u002Fhypersensitivity to local anesthetics or NSAIDs\n* Analgesics, anti-inflammatories, or antibiotics within 12 hours pre-treatment\n* Vertical root fracture, root resorption, or previous RCT\n* Radiographic periapical pathology\n* Non-restorable teeth\n* TMD, bruxism, or traumatic occlusion interfering with pain assessment","ALL","18 Years","60 Years",{"count":51,"type":52},40,"ESTIMATED","INTERVENTIONAL",[55],"PHASE4","This randomized controlled trial evaluates whether a final flush with 3% hypertonic saline, compared with 0.9% normal saline, reduces post-operative pain and periapical Substance P (SP) levels after single-visit root canal treatment in mandibular premolars with symptomatic irreversible pulpitis. Forty adult patients will be randomized 1:1. Pain will be measured with the Visual Analogue Scale (VAS) at 6, 12, 24, and 48 hours post-operatively. Periapical fluid SP levels will be measured by ELISA at two intra-operative time points (after working length determination, and after the final flush). The number of ibuprofen 400 mg tablets consumed within 24-48 hours will also be recorded.",[58],"Symptomatic Irreversible Pulpitis (SIP)",[60],"Hypertonic saline; Root canal irrigation; Substance P; Post-operative endodontic pain; Mandibular premolar; Single-visit root canal treatment","NOT_YET_RECRUITING","2026-07-08",{"date":64,"type":65},"2026-07-14","ACTUAL",{"date":67,"type":52},"2026-08-01",{"date":69,"type":52},"2027-01-01",{"name":5,"class":6}]