NCT07532200 SCN9A Gene Expression and Inflammatory Cytokines
| NCT ID | NCT07532200 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jamia Millia Islamia |
| Condition | Pulpitis - Irreversible |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2026-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-04-10 with a primary completion date of 2026-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Voltage-gated sodium channels, especially Nav1.7 encoded by the SCN9A gene, are key regulators of nociceptive transmission. Upregulation of SCN9A has been associated with increased neuronal excitability and heightened pain perception. In parallel, inflammatory cytokines such as interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1 beta (IL-1β) are known to sensitize peripheral nociceptors and reduce the efficacy of local anesthetics by modifying tissue environment and ion channel activity. However, the combined influence of SCN9A expression and inflammatory cytokines on anesthetic success in SIP has not been fully elucidated. This prospective case-control study aims to evaluate the association between SCN9A gene expression and inflammatory cytokine levels with the clinical success of IANB in patients with SIP affecting mandibular molars. Approximately 90-100 patients will be recruited and categorized into two groups based on anesthetic outcome: successful anesthesia and failed anesthesia. All patients will receive a standardized IANB using 2% lidocaine with 1:100,000 epinephrine. Anesthetic success will be determined based on the absence of pain during access cavity preparation and instrumentation. Following access and pulp extirpation, pulpal tissue samples will be collected. SCN9A gene expression will be assessed using quantitative real-time polymerase chain reaction (RT-qPCR), with relative expression calculated using the 2\^-ΔΔCt method. Inflammatory cytokine levels (IL-6, TNF-α, IL-1β) will be quantified using enzyme-linked immunosorbent assay (ELISA). The primary outcome will be the difference in SCN9A expression between failed and successful anesthesia groups. Secondary outcomes will include comparison of cytokine levels and evaluation of correlations between SCN9A expression and inflammatory markers. Statistical analysis will include group comparisons, correlation analysis, logistic regression, and receiver operating characteristic (ROC) curve analysis to assess the predictive value of these biomarkers.
Eligibility Criteria
Inclusion Criteria: * Patients aged 18-60 years * Systemically healthy individuals (ASA I or II) * Presence of a mandibular first or second molar diagnosed with symptomatic irreversible pulpitis * Vital tooth confirmed by positive response to pulp sensibility tests (cold test/EPT) * Moderate to severe preoperative pain (Heft-Parker VAS) * Patients requiring endodontic treatment under inferior alveolar nerve block * Ability and willingness to provide informed consent Exclusion Criteria: * Patients who have taken analgesics, anti-inflammatory drugs, or antibiotics within the last 48 hours * Presence of systemic diseases affecting pain perception or inflammation (e.g., diabetes, neuropathic disorders) * Pregnant or lactating women * Teeth with periapical abscess, swelling, or sinus tract * Non-vital teeth or teeth with previous endodontic treatment * Patients with known allergy to local anesthetic agents * Patients with limited mouth opening or anatomical conditions affecting IANB administration * Inability to understand pain assessment scales or comply with study protocol
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07532200 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Pulpitis - Irreversible. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07532200 currently recruiting?
Yes, NCT07532200 is actively recruiting participants. Contact the research team at vaggarwal@jmi.ac.in for enrollment information.
Where is the NCT07532200 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT07532200 clinical trial?
NCT07532200 is sponsored by Jamia Millia Islamia. The trial plans to enroll 100 participants.