RecruitingNot ApplicableNCT07306533

Effect of Menstrual Phase on the Anesthetic Efficacy

Effect of Menstrual Phase on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars

Sponsor

Jamia Millia Islamia

Enrollment

150 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

Pulpitis - Irreversible

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

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.

Exclusion Criteria6

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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREInferior Alveolar Nerve Block

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).