Effect of Menstrual Phase on the Anesthetic Efficacy
Recruiting now · Not applicable
Conditions studied: Pulpitis - Irreversible
In brief
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
Key facts
- Study ID
- NCT07306533
- Run by
- Jamia Millia Islamia
- People needed
- 150
- Starts
- 2025-09-11
- Expected to finish
- 2026-03-10
- Last updated by the study team
- 2025-12-29
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
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.
- 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 is running
- Faculty of Dentistry, JMI — New Delhi, Delhi(दिल्ली), India (enrolling)
Full record on ClinicalTrials.gov
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