Menstrual phase and how well lower-jaw dental anesthesia works
Official title: Effect of Menstrual Phase on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars
Run by Jamia Millia Islamia · NCT07306533 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Jamia Millia Islamia Academic / other |
| Locations | 1 site (New Delhi, Delhi(दिल्ली)) |
| Status | Recruiting |
| Started | September 11, 2025 |
| Main results expected | January 15, 2027 |
| Study ends | January 20, 2027 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT07306533 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Faculty of Dentistry, JMI
New Delhi, Delhi(दिल्ली), India Recruiting
Study contacts
- Study coordinator: Vivek Aggarwal, MDS
- Email: vaggarwal@jmi.ac.in
- Phone: +919818188358
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.