Pulpitis - IrreversibleGene ExpressioNCT07532200
SCN9A Gene Expression and Inflammatory Cytokines
An observational study of Pulpitis - Irreversible, run by Jamia Millia Islamia at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Inferior Alveolar Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 144 participants
- Where
- 1 siteIndia
- Study dates
- 10 Apr 2026to 25 Sep 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of adult patients presenting to the postgraduate endodontic clinic with symptomatic irreversible pulpitis in mandibular first or second molars requiring root canal treatment. Eligible participants will be systemically healthy (ASA I or II), aged between 18 and 60 years, and will report moderate to severe preoperative pain. Diagnosis will be established based on clinical findings, including spontaneous pain, prolonged response to cold testing, and absence of periapical pathology requiring surgical intervention.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Faculty of Dentistry
New Delhi, National Capital Territory of Delhi, 110025
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
The present study is designed as a prospective case-control investigation to assess the association between SCN9A gene expression and levels of key inflammatory cytokines with the clinical success of IANB. A total of approximately 100 patients diagnosed with SIP in mandibular molars will be recruited and categorized into two groups based on anesthetic outcome: successful anesthesia and failed anesthesia. Standardized IANB will be administered using 2% lidocaine with 1:100,000 epinephrine, and anesthetic success will be determined based on absence of pain during access cavity preparation and instrumentation.
Following access cavity preparation and pulp extirpation, biological samples will be collected. Pulpal tissue samples will be used for RNA extraction and subsequent quantitative real-time polymerase chain reaction (RT-qPCR) analysis to assess SCN9A gene expression. Relative expression levels will be calculated using the 2^-ΔΔCt method with appropriate housekeeping genes. In parallel, inflammatory cytokine levels (IL-6, TNF-α, IL-1β) will be quantified using enzyme-linked immunosorbent assay (ELISA) from pulpal tissue homogenates or gingival crevicular fluid, depending on feasibility.
The primary outcome of the study will be the difference in SCN9A expression between failed and successful anesthesia groups. Secondary outcomes will include comparison of cytokine levels between groups and evaluation of correlations between SCN9A expression and inflammatory markers. Data will be analyzed using appropriate statistical tests, including independent t-tests or non-parametric equivalents, correlation analysis, and logistic regression modeling. Additionally, receiver operating characteristic (ROC) curve analysis may be performed to assess the predictive value of these biomarkers for anesthetic failure.
This study aims to provide mechanistic insights into anesthetic failure in SIP by integrating molecular and inflammatory pathways. The findings may contribute to the development of predictive biomarkers and targeted therapeutic strategies to improve anesthetic success in endodontic practice.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Inferior Alveolar Nerve Block
- Keywords
- Symptomatic irreversible pulpitis, Inferior alveolar nerve block, Gene expression, RT-qPCR, Inflammatory cytokines
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
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.
Lip 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Inferior Alveolar Nerve Block | |
| 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. Receives: Procedure: Inferior Alveolar Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Inferior Alveolar Nerve Block (IANB)
The primary outcome will be the clinical success of the inferior alveolar nerve block (IANB), assessed during endodontic access cavity preparation and initial instrumentation. Anesthetic success will be defined as the absence of pain or the presence of only mild pain that does not require any supplementary anesthetic intervention. Anesthetic failure will be defined as the presence of moderate to severe pain necessitating additional anesthesia (e.g., intraligamentary or intrapulpal injection).
Measured: Assessed 15 minutes after administration of IANB, during access cavity preparation and initial instrumentation at the same visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start10 Apr 2026
- Primary completion25 Sep 2026
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Jamia Millia Islamia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vivek Aggarwal, Jamia Millia Islamia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532200
- Sponsor's protocol ID
- SCN9A IRRC- 173
- Acronym
- Gene Expressio
- Status last verified
- May 2026
- First submitted
- 8 Apr 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07532200
- Acronym / sponsor ID
- Gene Expressio / SCN9A IRRC- 173
- Conditions
- Pulpitis - Irreversible
- Keywords
- Symptomatic irreversible pulpitis, Inferior alveolar nerve block, Gene expression, RT-qPCR, Inflammatory cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Jamia Millia IslamiaUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present study is designed as a prospective case-control investigation to assess the association between SCN9A gene expression and levels of key inflammatory cytokines with the clinical success of IANB. A total of approximately 100 patients diagnosed with SIP in mandibular molars will be recruited and categorized into two groups based on anesthetic outcome: successful anesthesia and failed anesthesia. Standardized IANB will be administered using 2% lidocaine with 1:100,000 epinephrine, and anesthetic success will be determined based on absence of pain during access cavity preparation and instrumentation.
Following access cavity preparation and pulp extirpation, biological samples will be collected. Pulpal tissue samples will be used for RNA extraction and subsequent quantitative real-time polymerase chain reaction (RT-qPCR) analysis to assess SCN9A gene expression. Relative expression levels will be calculated using the 2^-ΔΔCt method with appropriate housekeeping genes. In parallel, inflammatory cytokine levels (IL-6, TNF-α, IL-1β) will be quantified using enzyme-linked immunosorbent assay (ELISA) from pulpal tissue homogenates or gingival crevicular fluid, depending on feasibility.
The primary outcome of the study will be the difference in SCN9A expression between failed and successful anesthesia groups. Secondary outcomes will include comparison of cytokine levels between groups and evaluation of correlations between SCN9A expression and inflammatory markers. Data will be analyzed using appropriate statistical tests, including independent t-tests or non-parametric equivalents, correlation analysis, and logistic regression modeling. Additionally, receiver operating characteristic (ROC) curve analysis may be performed to assess the predictive value of these biomarkers for anesthetic failure.
This study aims to provide mechanistic insights into anesthetic failure in SIP by integrating molecular and inflammatory pathways. The findings may contribute to the development of predictive biomarkers and targeted therapeutic strategies to improve anesthetic success in endodontic practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IANB Success (Adequate Anesthesia) Group | – | Procedure: Inferior Alveolar Nerve BlockThis 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 | – | Procedure: Inferior Alveolar Nerve BlockThis 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of adult patients presenting to the postgraduate endodontic clinic with symptomatic irreversible pulpitis in mandibular first or second molars requiring root canal treatment. Eligible participants will be systemically healthy (ASA I or II), aged between 18 and 60 years, and will report moderate to severe preoperative pain. Diagnosis will be established based on clinical findings, including spontaneous pain, prolonged response to cold testing, and absence of periapical pathology requiring surgical intervention.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inferior Alveolar Nerve BlockAll 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. Lip 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. | Procedure or surgery | IANB Failure (Inadequate Anesthesia) Group, IANB Success (Adequate Anesthesia) Group |
Primary outcome
Success of Inferior Alveolar Nerve Block (IANB)
Time frame: Assessed 15 minutes after administration of IANB, during access cavity preparation and initial instrumentation at the same visit
The primary outcome will be the clinical success of the inferior alveolar nerve block (IANB), assessed during endodontic access cavity preparation and initial instrumentation. Anesthetic success will be defined as the absence of pain or the presence of only mild pain that does not require any supplementary anesthetic intervention. Anesthetic failure will be defined as the presence of moderate to severe pain necessitating additional anesthesia (e.g., intraligamentary or intrapulpal injection).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 7 inclusion and 8 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 2 Nov 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?
Success of Inferior Alveolar Nerve Block (IANB) (time frame: Assessed 15 minutes after administration of IANB, during access cavity preparation and initial instrumentation at the same visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.