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NCT07701551
Hypertonic Saline as a Final Flush and Post-Operative Pain After Single Visit Root Canal Treatment in Mandibular Premolar.
Conditions: Symptomatic Irreversible Pulpitis (SIP)
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: Cairo University
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Age 18-60 years, any sex
* Systemically healthy
* Mandibular premolar with clinically/radiographically diagnosed symptomatic irreversible pulpitis (prolonged, exaggerated response to cold testing; no periapical radiolucency)
* Able to use the VAS scale and complete follow-up
Exclusion Criteria:
* Medically compromised patients
* Pregnant or lactating women
* Allergy/hypersensitivity to local anesthetics or NSAIDs
* Analgesics, anti-inflammatories, or antibiotics within 12 hours pre-treatment
* Vertical root fracture, root resorption, or previous RCT
* Radiographic periapical pathology
* Non-restorable teeth
* TMD, bruxism, or traumatic occlusion interfering with pain assessment
Source: ClinicalTrials.gov (NCT07701551). StuddyBuddy aggregates publicly available trial information.