Effect of Menstrual Phase on the Anesthetic Efficacy

NCT07306533 | Recruiting DMC

• 1 other identifier: Menstrual Phase
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational prospective clinical study is to learn whether the menstrual phase influences the anesthetic efficacy of inferior alveolar nerve block (IANB) in female patients aged 20-40 years with symptomatic irreversible pulpitis in mandibular molars. The main questions it aims to answer are: Does the success rate of IANB vary across different phases of the menstrual cycle? Are certain menstrual phases associated with a higher likelihood of anesthetic failure during endodontic access preparation? Researchers will compare five menstrual phase groups (menstrual, follicular, ovulatory, luteal, and premenstrual) to see if hormonal fluctuations affect anesthetic success. Participants will: Receive a standardized inferior alveolar nerve block using 2% lidocaine with 1:80,000 epinephrine Undergo cold testing and access cavity preparation to assess anesthetic success Have intraoperative pain recorded using the Heft-Parker Visual Analog Scale (HPVAS), with menstrual phase information recorded confidentially and blinded to the treating clinician

Conditions

Pulpitis - Irreversible

Keywords

IANB; pulpitis; anesthesia

Outcome Measures

Primary Outcomes (2)

• Anesthetic success

  The efficacy of anesthesia will be evaluated by two measures. First, pulpal anesthesia will be assessed using a cold test with Endo-Ice. Second, intraoperative pain will be recorded during access cavity preparation using the Heft-Parker Visual Analog Scale (HPVAS). Anesthetic outcome will be classified as either success or failure. Success will be defined as absence of response to cold testing along with no or only mild intraoperative pain (HPVAS ≤ 54 mm). Failure will be recorded when patients exhibit a positive cold test response and/or report moderate to severe intraoperative pain (HPVAS \> 54 mm) despite IANB administration.

  From enrollment to the end of treatment at 10 months, success will be evaluated after 5 minutes of administrtion if IANB.

• Intraoperative pain

  The intraoperative pain shall be measured using a 170mm HP visual anlouge scale.

  From enrollment to the end of treatment at 10 months, success will be evaluated during the treatment.

Study Arms (1)

Inferior Alveolar Nerve Block

EXPERIMENTAL

Patients will receive a standard inferior alveolar nerve block using 1.5 mL of 2% lidocaine with 1:80,000 epinephrine. The efficacy of anesthesia will be evaluated by two measures. First, pulpal anesthesia will be assessed using a cold test with Endo-Ice. Second, intraoperative pain will be recorded during access cavity preparation using the Heft-Parker Visual Analog Scale (HPVAS). Anesthetic outcome will be classified as either success or failure. Success will be defined as absence of response to cold testing along with no or only mild intraoperative pain (HPVAS ≤ 54 mm).

Procedure: Inferior Alveolar Nerve Block

Interventions

Inferior Alveolar Nerve Block PROCEDURE

The patients will receive a standard inferior alveolar nerve block using 1.5 mL of 2% lidocaine with 1:80,000 epinephrine. The efficacy of anesthesia will be evaluated by two measures. First, pulpal anesthesia will be assessed using a cold test with Endo-Ice. Second, intraoperative pain will be recorded during access cavity preparation using the Heft-Parker Visual Analog Scale (HPVAS). Anesthetic outcome will be classified as either success or failure. Success will be defined as absence of response to cold testing along with no or only mild intraoperative pain (HPVAS ≤ 54 mm).

Inferior Alveolar Nerve Block

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Mensturating females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 20-40 years.
• Regular menstrual cycles (28 ± 3 days).
• Diagnosed with symptomatic irreversible pulpitis in mandibular molars.
• Indicated for root canal therapy.

You may not qualify if:

• Use of oral contraceptives or hormonal therapy.
• Irregular menstrual cycles.
• Pregnancy or lactation.
• Systemic disease affecting pain perception (e.g., diabetes, neuropathies).
• Recent use of analgesics or sedatives (within 24 hours).
• Allergy to local anesthetics.

Sponsors & Collaborators

• Jamia Millia Islamia: lead

Study Sites (1)

Faculty of Dentistry, JMI

New Delhi, Delhi(दिल्ली), 110025, India

RECRUITING

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Vivek Aggarwal, MDS

CONTACT

+919818188358; vaggarwal@jmi.ac.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 29, 2025
• Study Start: September 11, 2025
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After 1 year of completion of study

Locations

IN (1)