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

ConditionSymptomatic Irreversible Pulpitis (SIP)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCairo University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Medically compromised patients

Pregnant or lactating women

Allergy/hypersensitivity to local anesthetics or NSAIDs

Analgesics, anti-inflammatories, or antibiotics within 12 hours pre-treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Normal (0.9%) saline

    Drug

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

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Normal Saline 0.09Other 1 intervention
Group B: Hypertonic Saline 3%Experimental treatment 1 intervention

Trial outcomes

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)

Time frame
6 hours post-operatively

Secondary outcomes

1

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

VAS, 0-10, same categorization as primary

Time frame
12, 24, and 48 hours post-operatively
2

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

Quantified by ELISA (human Substance P kit) from periapical fluid collected via paper point; pg/mL

Time frame
S1 = after working length determination (intra-operative); S2 = immediately after final flush (intra-operative)
3

Number of rescue analgesic tablets consumed

Ibuprofen 400 mg tablets, patient-recorded tablet-count chart, max 3 tablets/24 h

Time frame
24 and 48 hours post-operatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: