Symptomatic Irreversible Pulpitis (SIP)Phase 4HypertonicNCT07701551
Hypertonic Saline as a Final Flush and Post-Operative Pain After Single Visit Root Canal Treatment in Mandibular Premolar.
A Phase 4 study testing Normal (0.9%) saline and Hypertonic 3% saline in people with Symptomatic Irreversible Pulpitis (SIP), run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP)
- What is being tested?
- Normal (0.9%) saline and Hypertonic 3% saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Jan 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Being tested
- Normal (0.9%) saline, Hypertonic 3% saline
- Keywords
- Hypertonic saline; Root canal irrigation; Substance P; Post-operative endodontic pain; Mandibular premolar; Single-visit root canal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal (0.9%) salineDrug
Isotonic 0.9% NaCl solution used as final canal flush, no pharmacological activity
Hypertonic 3% salineDrug
Osmotic/anti-inflammatory final irrigant hypothesized to reduce periapical edema and suppress pro-inflammatory cytokine-mediated SP release via NF-κB pathway inhibition.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline 0.09 | Other | Isotonic, biologically inert final irrigant; mechanical debridement only, no pharmacological activity. Receives: Drug: Normal (0.9%) saline |
| Hypertonic Saline 3% | Experimental | Isotonic, biologically inert final irrigant; mechanical debridement only, no pharmacological activity. Receives: Drug: Hypertonic 3% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 hours post-operatively
Secondary outcomes (3)
Post-operative pain intensity at 12, 24, and 48 hours
VAS, 0-10, same categorization as primary
Measured: 12, 24, and 48 hours post-operatively
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
Measured: S1 = after working length determination (intra-operative); S2 = immediately after final flush (intra-operative)
Number of rescue analgesic tablets consumed
Ibuprofen 400 mg tablets, patient-recorded tablet-count chart, max 3 tablets/24 h
Measured: 24 and 48 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kariman Mohammed Mohammed Amin Ismaiel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701551
- Sponsor's protocol ID
- ENDO 3.3.3
- Acronym
- Hypertonic
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No