Menstrual phase and how well lower-jaw dental anesthesia works
Effect of Menstrual Phase on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars
This research will test whether different menstrual cycle phases change how well an inferior alveolar nerve block works for women (20–40) with painful irreversible pulpitis in lower molars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Jamia Millia Islamia Academic / other |
| Locations | 1 site (New Delhi, Delhi(दिल्ली)) |
| Trial ID | NCT07306533 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling women aged 20–40 with symptomatic irreversible pulpitis in mandibular molars and regular menstrual cycles. Participants receive a standardized inferior alveolar nerve block (2% lidocaine with 1:80,000 epinephrine) and undergo cold testing and access cavity preparation to determine anesthetic success. Researchers record intraoperative pain using the Heft-Parker Visual Analog Scale and group results by five menstrual phases (menstrual, follicular, ovulatory, luteal, premenstrual). Success rates across phases will be compared to see if hormonal cycle stage is associated with higher likelihood of anesthetic failure.
Who should consider this trial
Good fit: Women aged 20–40 with regular 28 ± 3 day menstrual cycles, symptomatic irreversible pulpitis in mandibular molars, and no use of hormonal contraceptives or interfering systemic conditions.
Not a fit: Those who are pregnant or lactating, use oral contraceptives or hormonal therapy, have irregular cycles, recent analgesic use, systemic diseases affecting pain perception, or are outside the age range are not represented and may not benefit.
Why it matters
Potential benefit: If menstrual phase affects anesthesia success, clinicians could anticipate failures and plan supplemental anesthesia to reduce pain during root canal treatment for menstruating women.
How similar studies have performed: While hormonal influences on pain are reported in the literature, few clinical studies have directly examined menstrual phase effects on inferior alveolar nerve block success, so this approach is relatively novel in endodontics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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. * Willing to provide informed consent. Exclusion Criteria * 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.
Where this trial is running
New Delhi, Delhi(दिल्ली)
- Faculty of Dentistry, JMI — New Delhi, Delhi(दिल्ली), India (Recruiting)
Study contacts
- Study coordinator: Vivek Aggarwal, MDS
- Email: vaggarwal@jmi.ac.in
- Phone: +919818188358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.