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

NCT07701551 | Not Yet Recruiting Phase 4

• 1 other identifier: ENDO 3.3.3
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Hypertonic saline; Root canal irrigation; Substance P; Post-operative endodontic pain; Mandibular premolar; Single-visit root canal treatment

Outcome Measures

Primary Outcomes (1)

• Post-operative pain intensity at 6 hours

  Visual Analogue Scale (VAS), 0-10 (0 = no pain, 1-3 mild, 4-6 moderate, 7-10 severe)

  6 hours post-operatively

Secondary Outcomes (3)

• Post-operative pain intensity at 12, 24, and 48 hours

  12, 24, and 48 hours post-operatively

• Change in periapical Substance P expression (ΔSP = S2 - S1)

  S1 = after working length determination (intra-operative); S2 = immediately after final flush (intra-operative)

• Number of rescue analgesic tablets consumed

  24 and 48 hours post-operatively

Study Arms (2)

Normal Saline 0.09

OTHER

Isotonic, biologically inert final irrigant; mechanical debridement only, no pharmacological activity.

Drug: Normal (0.9%) saline

Hypertonic Saline 3%

EXPERIMENTAL

Isotonic, biologically inert final irrigant; mechanical debridement only, no pharmacological activity.

Drug: Hypertonic 3% saline

Interventions

Normal (0.9%) saline DRUG

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

Normal Saline 0.09

Hypertonic 3% saline DRUG

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

Hypertonic Saline 3%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Kariman Ameen Ismaiel

CONTACT

+201013665586; kariman.ameen@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking Description: Both irrigants are clear, colorless, odorless aqueous solutions administered identically, so participants cannot distinguish allocation. The laboratory technician performing ELISA and the biostatistician performing final analysis are blinded to group via coded datasets; unmasking occurs only after analysis is complete. The treating investigator cannot be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07