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Hypertonic Saline as a Final Flush and Post-Operative Pain After Single Visit Root Canal Treatment in Mandibular Premolar.

NCT07701551 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-14

No results posted yet for this study

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.

Conditions

  • Symptomatic Irreversible Pulpitis (SIP)

Interventions

DRUG

Normal (0.9%) saline

Isotonic 0.9% NaCl solution used as final canal flush, no pharmacological activity

DRUG

Hypertonic 3% saline

Osmotic/anti-inflammatory final irrigant hypothesized to reduce periapical edema and suppress pro-inflammatory cytokine-mediated SP release via NF-κB pathway inhibition.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-01-01
Completion
2027-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07701551 on ClinicalTrials.gov