Actively Recruiting
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
Led by Jamia Millia Islamia · Updated on 2026-06-01
100
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the expression of the SCN9A gene, which codes for a sodium channel involved in pain transmission, and levels of inflammatory cytokines relate to the success of inferior alveolar nerve block (IANB) anesthesia in patients with symptomatic irreversible pulpitis (SIP) affecting mandibular molars. The study is a prospective case-control design enrolling about 90-100 patients to understand why anesthesia sometimes fails during dental procedures despite standard treatment. Understanding these molecular and inflammatory factors may help improve anesthetic outcomes in endodontics. All participants will receive a standardized IANB using 2% lidocaine with 1:100,000 epinephrine administered by a conventional technique. Patients will be grouped based on whether anesthesia is successful or fails, determined by their pain experience during access cavity preparation and initial instrumentation. After confirming anesthesia status, dental pulp tissue samples will be collected for molecular analysis, including SCN9A gene expression measured by quantitative real-time PCR and levels of inflammatory cytokines IL-6, TNF-alpha, and IL-1 beta quantified by ELISA. Participants will undergo assessment of pain during the dental procedure to classify anesthetic success. Biological samples collected during treatment will be analyzed to compare gene and cytokine levels between groups. The main outcome measured is anesthetic success assessed 15 minutes after IANB administration during the procedure. Secondary outcomes include correlations between SCN9A expression and inflammatory markers. Statistical analyses will evaluate these relationships to identify potential biomarkers predicting anesthesia failure. The study's duration spans from recruitment to completion of data collection, ending in September 2026.
CONDITIONS
Brief Title
SCN9A Gene Expression and Inflammatory Cytokines
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of intervention
Participants receive a standardized inferior alveolar nerve block (IANB) and undergo assessment for anesthetic success during access cavity preparation and initial instrumentation.
1 visit (in-person)
Duration - Same day as intervention
Following access cavity preparation and pulp extirpation, pulpal tissue samples are collected to analyze SCN9A gene expression and inflammatory cytokine levels.
Sample collection occurs during the intervention visit
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry
New Delhi, National Capital Territory of Delhi, India, 110025
Actively Recruiting
Research Team
V
Vivek Aggarwal, MDS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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