Hypertonic Saline as a Final Flush and Post-Operative Pain After Single Visit Root Canal Treatment in Mandibular Premolar.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Normal (0.9%) saline, Hypertonic 3% saline.
- Who it may be relevant to
- Registry conditions: Symptomatic Irreversible Pulpitis (SIP). Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Post-operative endodontic pain is linked to periapical release of Substance P (SP), a neuropeptide that sustains neurogenic inflammation via NK-1 receptor binding. 3% hypertonic saline has documented osmotic decongestant and NF-κB-mediated anti-inflammatory/cytokine-suppressive effects in non-dental models, providing biological rationale for its use as a final irrigant. This is a two-arm, parallel-group, participant- and assessor-blinded RCT conducted at the outpatient endodontic clinic, Faculty of Dentistry, Cairo University. After standardized access, working length determination, and a baseline periapical fluid sample (S1), canals will be shaped with continuous rotary NiTi instrumentation and irrigated with 2.5% NaOCl. After smear layer removal (2.5% NaOCl then 17% EDTA), participants receive a final flush of either 5 mL 0.9% normal saline (control) or 5 mL 3% hypertonic saline (intervention), delivered via a 30-gauge side-vented needle 2 mm short of working length. A second periapical fluid sample (S2) is then collected. Canals are obturated by lateral compaction in the same visit. Participants record VAS pain scores pre-operatively and at 6, 12, 24, and 48 hours, and log ibuprofen 400 mg tablet consumption at 24 and 48 hours. SP will be quantified from S1/S2 samples by ELISA, blinded to group allocation.
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.
Primary outcome measures
- Post-operative pain intensity at 6 hours [Time frame: 6 hours post-operatively]
Secondary outcome measures (3)
- Post-operative pain intensity at 12, 24, and 48 hours [Time frame: 12, 24, and 48 hours post-operatively]
- Change in periapical Substance P expression (ΔSP = S2 - S1) [Time frame: S1 = after working length determination (intra-operative); S2 = immediately after final flush (intra-operative)]
- Number of rescue analgesic tablets consumed [Time frame: 24 and 48 hours post-operatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07701551 · ENDO 3.3.3