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Pulpitis - IrreversibleSNP&IANBNCT07012382

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

A study testing Inferior Alveolar Nerve Block and Inferior-Alveolar-Nerve-Block in people with Pulpitis - Irreversible, run by Jamia Millia Islamia at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Pulpitis - Irreversible
What is being tested?
Inferior Alveolar Nerve Block and Inferior-Alveolar-Nerve-Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteIndia
Study dates
10 May 2025to 27 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site
  • Faculty of Dentistry, Jamia Millia Islamia

    New Delhi, New Delhi, 110025

Other trials in India

About this study

Official title: Association Between Single Gene Polymorphism (rs6746030) and the Success Rate of Inferior Alveolar Nerve Block in Patients Undergoing Endodontic Treatment

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.

Read the detailed description

The successful administration of local anesthesia is critical for the effective management of pain in endodontic procedures. Among the various local anesthesia techniques, the inferior alveolar nerve block (IANB) is most commonly employed for procedures involving mandibular teeth. However, the IANB often fails to provide profound pulpal anesthesia, especially in cases of irreversible pulpitis. Studies have reported IANB failure rates ranging from 30% to as high as 80% despite proper technique and appropriate choice of anesthetic agents. These failures not only lead to intraoperative pain and patient discomfort but also challenge the clinician's ability to perform the procedure efficiently.Several contributing factors have been proposed to explain this high failure rate, including anatomical variability, inflammation-induced changes in local tissue pH, central sensitization, and psychological factors. More recently, there has been growing interest in the role of genetic predisposition in modulating an individual's response to local anesthetics. Pharmacogenetic studies have suggested that genetic variability in sodium channel genes may influence nociceptive transmission and anesthetic response. The SCN9A gene, located on chromosome 2q24.3, encodes the Nav1.7 voltage-gated sodium channel, which is predominantly expressed in nociceptive neurons of the dorsal root ganglia and trigeminal ganglia (Dib-Hajj et al., 2007). This channel plays a pivotal role in the generation and propagation of action potentials in response to painful stimuli. Mutations and polymorphisms in SCN9A have been linked to various pain syndromes, such as primary erythromelalgia and paroxysmal extreme pain disorder, as well as congenital insensitivity to pain. Notably, the rs6746030 (G>A) SNP, resulting in a missense mutation (R1150W), has been associated with increased pain sensitivity in healthy individuals and altered response to analgesics.

Given this background, it is plausible that genetic variability in SCN9A may also influence the success of local anesthetic techniques like IANB. The proposed study aims to examine whether the SCN9A rs6746030 polymorphism affects the success rate of IANB in patients undergoing root canal treatment for mandibular molars with irreversible pulpitis. Identifying such a genetic association could lead to the development of predictive models for anesthetic response and open avenues for personalized dental anesthesia.

Aims and Objectives: To investigate the association between the SCN9A rs6746030 polymorphism and the clinical success of the inferior alveolar nerve block in patients undergoing endodontic treatment.

This is a prospective case-control genetic association study.A total of 200 patients presenting to the Department of Conservative Dentistry and Endodontics with a diagnosis of irreversible pulpitis in mandibular molars will be enrolled. 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.

After clinical grouping, a buccal swab will be collected from each participant using sterile DNA collection swabs. The inner cheek will be rubbed for 30-60 seconds, and samples will be stored in sterile tubes at -20°C until processing. DNA will be extracted using the QIAamp DNA Mini Kit (Qiagen, Germany) following the manufacturer's protocol. DNA concentration and purity will be assessed using a NanoDrop spectrophotometer. 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.

Descriptive statistics will be used to report allele and genotype frequencies. The Hardy-Weinberg equilibrium (HWE) will be assessed using the chi-square test. The association between genotype and anesthetic outcome will be analyzed using chi-square or Fisher's exact test as appropriate. Logistic regression analysis will be used to adjust for confounding factors such as age, gender, and preoperative pain intensity. A p-value of <0.05 will be considered statistically significant. Data will be analyzed using SPSS v25.0 (IBM Corp., USA).

Being tested
Inferior Alveolar Nerve Block, Inferior-Alveolar-Nerve-Block
Keywords
irreversible pulpitis, Mandibular Molar, SNP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inferior Alveolar Nerve BlockProcedure or surgery

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

  • Inferior-Alveolar-Nerve-BlockProcedure or surgery

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

Study groups in NCT07012382
Study groupRoleWhat they receive
Failed inferior alveolar nerve blockActive comparatorPatients with persistent response to cold testing and/or intraoperative pain despite inferior alveolar nerve block
Receives: Procedure: Inferior Alveolar Nerve Block
Successful inferior alveolar nerve blockExperimentalPatients with negative response to cold testing and no pain during access cavity preparation
Receives: Procedure: Inferior-Alveolar-Nerve-Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At day 1, at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study start10 May 2025
  3. Primary completion27 Nov 2025
  4. Study completion27 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07012382
Sponsor's protocol ID
SNP-Proposal-165
Acronym
SNP&IANB
Status last verified
May 2025
First submitted
22 May 2025
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: There is a plan to make IPD available. The description of the variables, and type of data collected for each individual will be provided on request to the researchers.

Publications

  • 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.

    PubMed 20212137
  • 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.

    PubMed 23232607

Questions about this trial

What is this clinical trial studying?

A study testing Inferior Alveolar Nerve Block and Inferior-Alveolar-Nerve-Block in people with Pulpitis - Irreversible, run by Jamia Millia Islamia at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rs6746030 SNP in SCN9A genotyping (time frame: At day 1, at baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07012382, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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