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Association of SCN9A (Nav1.7) Gene Expression and Inflammatory Cytokines (IL-6, TNF-α, IL-1β) With the Success of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Prospective Case-Control Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
India
Faculty of Dentistry
RECRUITING
New Delhi
Contact Information
Primary
Vivek Aggarwal, MDS
vaggarwal@jmi.ac.in
01126983646
Time Frame
Start Date: 2026-04-10
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 100
Treatments
IANB Success (Adequate Anesthesia) Group
This cohort will include patients with symptomatic irreversible pulpitis in mandibular molars who achieve successful pulpal anesthesia following administration of a standardized inferior alveolar nerve block (IANB) using 2% lidocaine with 1:100,000 epinephrine. Anesthetic success will be defined as the absence of pain (no or mild pain) during access cavity preparation and initial instrumentation without the need for any supplementary anesthetic techniques. Following confirmation of anesthesia, access cavity preparation and pulp extirpation will be performed, and pulpal tissue samples will be collected for analysis of SCN9A gene expression (RT-qPCR) and inflammatory cytokine levels (IL-6, TNF-α, IL-1β) using ELISA.
IANB Failure (Inadequate Anesthesia) Group
This cohort will include patients with symptomatic irreversible pulpitis in mandibular molars who experience inadequate pulpal anesthesia following administration of a standardized inferior alveolar nerve block (IANB) using 2% lidocaine with 1:100,000 epinephrine. Anesthetic failure will be defined as the presence of moderate to severe pain during access cavity preparation or instrumentation, necessitating the use of supplementary anesthetic techniques (e.g., intraligamentary or intrapulpal injections). Pulpal tissue samples will be collected after access cavity preparation and pulp extirpation for analysis of SCN9A gene expression (RT-qPCR) and inflammatory cytokines (IL-6, TNF-α, IL-1β) using ELISA.
Related Therapeutic Areas
Sponsors
Leads: Jamia Millia Islamia

This content was sourced from clinicaltrials.gov