[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633862":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":66,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Jamia Millia Islamia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IANB Success (Adequate Anesthesia) Group",null,"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.",[13],"Procedure: Inferior Alveolar Nerve Block",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"PROCEDURE","Inferior Alveolar Nerve Block","All participants will receive a standardized inferior alveolar nerve block (IANB) administered using 2% lidocaine with 1:80,000 epinephrine. The injection will be performed using a conventional Halsted technique with a 27-gauge long needle under strict aseptic conditions. The needle will be inserted at the pterygomandibular raphe region, advancing until bony contact is achieved near the mandibular foramen. Following negative aspiration, approximately 1.8 mL of anesthetic solution will be deposited slowly over 60-90 seconds.\n\nLip numbness will be assessed after 10-15 minutes to confirm nerve block onset. No additional anesthetic techniques will be used prior to the assessment of primary anesthetic success. Endodontic access cavity preparation will then be initiated, and pain response during access and initial instrumentation will be recorded using a standardized pain scale. Anesthetic success or failure will be determined based on the patient's pain response, as per predefined criteria.",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Vivek Aggarwal, MDS","CONTACT","01126983646","vaggarwal@jmi.ac.in",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Faculty of Dentistry","RECRUITING","New Delhi","National Capital Territory of Delhi","110025","India","IN",{"type":40,"coordinates":41},"Point",[42,43],77.2148,28.62137,{"lat":43,"lon":42},[46],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Dr. Vivek Aggarwal","Professor","100633862","scn9a-gene-expression-and-inflammatory-cytokines-100633862",false,"NCT07532200","SCN9A Gene Expression and Inflammatory Cytokines","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","Gene Expressio","Inclusion Criteria:\n\n* Patients aged 18-60 years\n* Systemically healthy individuals (ASA I or II)\n* Presence of a mandibular first or second molar diagnosed with symptomatic irreversible pulpitis\n* Vital tooth confirmed by positive response to pulp sensibility tests (cold test\u002FEPT)\n* Moderate to severe preoperative pain (Heft-Parker VAS)\n* Patients requiring endodontic treatment under inferior alveolar nerve block\n* Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n* Patients who have taken analgesics, anti-inflammatory drugs, or antibiotics within the last 48 hours\n* Presence of systemic diseases affecting pain perception or inflammation (e.g., diabetes, neuropathic disorders)\n* Pregnant or lactating women\n* Teeth with periapical abscess, swelling, or sinus tract\n* Non-vital teeth or teeth with previous endodontic treatment\n* Patients with known allergy to local anesthetic agents\n* Patients with limited mouth opening or anatomical conditions affecting IANB administration\n* Inability to understand pain assessment scales or comply with study protocol",true,"ALL","18 Years","50 Years",{"count":64,"type":65},100,"ESTIMATED","1 Month","OBSERVATIONAL","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.\n\nThis 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.\n\nFollowing 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).\n\nThe 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.",[70],"Pulpitis - Irreversible",[72,73,74,75,76],"Symptomatic irreversible pulpitis","Inferior alveolar nerve block","Gene expression","RT-qPCR","Inflammatory cytokines","2026-05-27",{"date":79,"type":80},"2026-06-01","ACTUAL",{"date":82,"type":80},"2026-04-10",{"date":84,"type":65},"2026-09-30",{"name":5,"class":6},1]