Effect of Menstrual Phase on the Anesthetic Efficacy
ConditionPulpitis - Irreversible
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorJamia Millia Islamia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Use of oral contraceptives or hormonal therapy.
Irregular menstrual cycles.
Pregnancy or lactation.
Systemic disease affecting pain perception (e.g., diabetes, neuropathies).
Trial design
Design model
Single group
Treatments tested in this trial
Inferior Alveolar Nerve Block
Procedure/SurgeryThe 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).
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Inferior Alveolar Nerve BlockExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Anesthetic success
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). Failure will be recorded when patients exhibit a positive cold test response and/or report moderate to severe intraoperative pain (HPVAS \> 54 mm) despite IANB administration.
Time frame
From enrollment to the end of treatment at 10 months, success will be evaluated after 5 minutes of administrtion if IANB.2
Intraoperative pain
The intraoperative pain shall be measured using a 170mm HP visual anlouge scale.
Time frame
From enrollment to the end of treatment at 10 months, success will be evaluated during the treatment.Sponsors and contacts
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Source ClinicalTrials.gov