Single Gene Polymorphism and the Success Rate of Inferior Alveolar Nerve Block

NCT07012382 | Completed DMC

• 1 other identifier: SNP-Proposal-165
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The inferior alveolar nerve block (IANB) is one of the most commonly used techniques in dentistry to achieve mandibular anesthesia during endodontic treatment. Despite its widespread use, the success rate of IANB is highly variable, with failure rates reported to range from 30% to 80% in patients with irreversible pulpitis. While several anatomical and clinical factors have been implicated, genetic variations in pain signaling pathways have been increasingly recognized as potential contributors to anesthetic failure. The SCN9A gene, which encodes the voltage-gated sodium channel Nav1.7, plays a critical role in nociception and pain modulation. The single nucleotide polymorphism (SNP) rs6746030 (G\>A) in SCN9A has been shown to alter channel function and has been associated with variable pain sensitivity and response to analgesia. This study aims to investigate the association between the SCN9A rs6746030 polymorphism and the success rate of IANB in patients undergoing root canal treatment. A total of 200 patients diagnosed with irreversible pulpitis in mandibular molars will be recruited. Based on anesthetic outcome, they will be divided into two groups: 100 patients with successful IANB and 100 patients with documented anesthetic failure. Buccal swab samples will be collected from each participant, and DNA will be extracted and genotyped using a TaqMan SNP assay. The frequency of SCN9A genotypes (GG, GA, AA) will be compared between the two groups to determine whether there is a statistically significant association with anesthetic outcome. The findings of this study will help identify genetic predictors of anesthetic failure and may provide a foundation for personalized anesthetic strategies in endodontic practice.

Conditions

Pulpitis - Irreversible

Keywords

irreversible pulpitis; Mandibular Molar; SNP

Outcome Measures

Primary Outcomes (1)

• rs6746030 SNP in SCN9A genotyping

  The rs6746030 SNP in SCN9A will be genotyped using a TaqMan SNP Genotyping Assay (Thermo Fisher Scientific, Assay ID: C\_29995789\_10). The PCR reactions will be performed in a 96-well format using Applied Biosystems StepOnePlus real-time PCR system. The reaction mix will include TaqMan Genotyping Master Mix, allele-specific probes, and extracted DNA. The thermal profile will consist of an initial denaturation at 95°C for 10 minutes, followed by 40 cycles of denaturation at 95°C for 15 seconds and annealing/extension at 60°C for 1 minute. Genotype Classification * GG - Homozygous wild-type. * GA - Heterozygous. * AA - Homozygous mutant.

  At day 1, at baseline

Study Arms (2)

Failed inferior alveolar nerve block

ACTIVE COMPARATOR

Patients with persistent response to cold testing and/or intraoperative pain despite inferior alveolar nerve block

Procedure: Inferior Alveolar Nerve Block

Successful inferior alveolar nerve block

EXPERIMENTAL

Patients with negative response to cold testing and no pain during access cavity preparation

Procedure: Inferior-Alveolar-Nerve-Block

Interventions

Inferior-Alveolar-Nerve-Block PROCEDURE

Administration of IANB with 2% lidocaine containing 1:80,000 epinephrine

Successful inferior alveolar nerve block

Inferior Alveolar Nerve Block PROCEDURE

Administration of standard IANB with 2% lidocaine containing 1:80,000 epinephrine

Failed inferior alveolar nerve block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years.
• Requiring root canal treatment in mandibular first or second molars diagnosed with irreversible pulpitis.
• Administration of standard IANB with 2% lidocaine containing 1:80,000 epinephrine.
• Ability to provide informed consent.

You may not qualify if:

• Systemic conditions affecting pain perception (e.g., diabetes, neuropathies).
• Known allergy to local anesthetics.
• Use of analgesics or anti-inflammatory medications within 24 hours before the procedure.
• Pregnant or lactating women.
• Patients with extensive periapical pathology or swelling.
• Inability to comply with study requirements.

Sponsors & Collaborators

• Jamia Millia Islamia: lead

Study Sites (1)

Faculty of Dentistry, Jamia Millia Islamia

New Delhi, New Delhi, 110025, India

Location

Related Publications (2)

• Reimann F, Cox JJ, Belfer I, Diatchenko L, Zaykin DV, McHale DP, Drenth JP, Dai F, Wheeler J, Sanders F, Wood L, Wu TX, Karppinen J, Nikolajsen L, Mannikko M, Max MB, Kiselycznyk C, Poddar M, Te Morsche RH, Smith S, Gibson D, Kelempisioti A, Maixner W, Gribble FM, Woods CG. Pain perception is altered by a nucleotide polymorphism in SCN9A. Proc Natl Acad Sci U S A. 2010 Mar 16;107(11):5148-53. doi: 10.1073/pnas.0913181107. Epub 2010 Mar 8.

  PMID: 20212137 RESULT

• Dib-Hajj SD, Yang Y, Black JA, Waxman SG. The Na(V)1.7 sodium channel: from molecule to man. Nat Rev Neurosci. 2013 Jan;14(1):49-62. doi: 10.1038/nrn3404. Epub 2012 Dec 12.

  PMID: 23232607 RESULT

Study Officials

• Vivek Aggarwal, MDS

  Jamia Millia Islamia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinding shall be ensured
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be allocated to two groups based on the outcome of IANB: * Group A (Success Group): Patients with negative response to cold testing and no pain during access cavity preparation. * Group B (Failure Group): Patients with persistent response to cold testing and/or intraoperative pain despite IANB.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 10, 2025
• Study Start: May 10, 2025
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: March 19, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: within 1 month of publication
• Access Criteria: The description of the variables, and type of data collected for each individual will be provided on request to the researchers.

Locations

IN (1)