Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID07306533

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

Led by Jamia Millia Islamia · Updated on 2025-12-29

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand if the phase of the menstrual cycle affects how well an inferior alveolar nerve block (IANB) works to control pain in women aged 20 to 40 years with symptomatic irreversible pulpitis in their lower molars. The study explores whether anesthetic success varies across five menstrual phases—menstrual, follicular, ovulatory, luteal, and premenstrual—due to hormonal changes that may influence pain perception and nerve response. Participants will receive a standard IANB injection using 1.5 mL of 2% lidocaine with 1:80,000 epinephrine. The anesthetic effect will be tested by applying a cold stimulus and measuring pain during dental access preparation using the Heft-Parker Visual Analog Scale (HPVAS). The study groups are based on self-reported menstrual phases, which are verified and kept confidential from the treating clinician to ensure unbiased assessment. During the study, participants will undergo pain testing immediately after anesthesia and during the dental procedure. Researchers will record anesthetic success, defined as no or mild pain response, and failure if moderate to severe pain occurs. Data analysis will compare success rates across menstrual phases while considering factors like age and initial pain. The study will last approximately nine months, including recruitment and data analysis phases.

CONDITIONS

Brief Title

Effect of Menstrual Phase on the Anesthetic Efficacy

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 20-40 years
  • Regular menstrual cycles of 28 ± 3 days
  • Diagnosed with symptomatic irreversible pulpitis in mandibular molars
  • Indicated for root canal therapy
  • Willing to provide informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit with evaluation during and shortly after administration

Participants receive a standard inferior alveolar nerve block to manage pain from symptomatic irreversible pulpitis in mandibular molars. The efficacy of anesthesia is evaluated using a cold test and intraoperative pain measurement during the dental procedure.

1 treatment visit with anesthetic efficacy evaluated within 5 minutes after injection and during the procedure

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry, JMI

New Delhi, Delhi(दिल्ली), India, 110025

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Research Team

V

Vivek Aggarwal, MDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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