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CompletedNCT07291518PEP-MCUpdated Dec 26, 2025

Post-Endodontic Pain According to Menstrual Cycle Phases

An observational study in Root Canal Treatment, sponsored by Ahter Sanal Cikman. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by Ahter Sanal Cikman · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
99
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This study aimed to evaluate whether the phase of the menstrual cycle affects pain after root canal treatment. A total of 99 patients (72 females and 27 males) who needed root canal treatment in lower molar teeth were included. Female participants were grouped according to their menstrual cycle phase: menstrual, proliferative, and secretory. All patients received the same endodontic treatment procedure under local anesthesia. Postoperative pain intensity was recorded using a Visual Analog Scale (VAS) at 8 hours, 8-24 hours, 24-48 hours, and 48-72 hours after treatment. Analgesic (ibuprofen) use was also recorded. The results showed that women in the menstrual and secretory phases experienced higher pain levels than men, while pain levels in the proliferative phase were similar to those in men. The findings suggest that the menstrual cycle phase may influence short-term pain perception after root canal treatment.

Read the detailed description

This prospective clinical study investigates the effect of menstrual cycle phase on postendodontic pain intensity in female patients compared to male patients. Ninety-nine participants requiring endodontic treatment for asymptomatic necrotic mandibular molars were enrolled in the study. Female participants were categorized into menstrual, proliferative, or secretory phases based on the first day of their last menstrual period. All treatments were standardized and performed under local anesthesia with rubber dam isolation, including root canal preparation using rotary files, irrigation with 2.5% sodium hypochlorite and 17% EDTA, and obturation with root canal sealer. Postoperative pain was self-assessed using a Visual Analog Scale (VAS) at multiple time points for up to 72 hours, and analgesic consumption was recorded. Data were analyzed with nonparametric tests to compare pain levels across cycle phases and in male participants. This study provides detailed information on potential hormonal influences on postoperative pain and may guide clinicians in planning endodontic treatments to maximize postoperative comfort in female patients.

02

Conditions studied

  • Root Canal Treatment

Keywords

  • Endodontic treatment
  • Post-endodontic pain
  • Pain perception
  • Mandibular molars
  • Dental pain
  • postoperative pain
  • Menstrual cycle
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population consists of 99 adult patients (72 females and 27 males), aged 18-50 years, requiring endodontic treatment for asymptomatic necrotic mandibular first or second molars. Female participants have regular menstrual cycles and are categorized into menstrual, proliferative, or secretory phases. Patients with systemic diseases, smoking habits, preoperative pain, parafunctional habits, teeth requiring prosthetic restoration, immature teeth, periodontal probing depth greater than 3 mm, or irregular menstrual cycles are excluded. All participants provided written informed consent prior to enrollment.

Inclusion criteria

  • Age 18-50 years
  • Male or female patients requiring endodontic treatment of asymptomatic
  • Necrotic mandibular first or second molars
  • Female patients with regular menstrual cycles
  • Patients who have not taken analgesics in the last 3 days
  • Patients willing to provide written informed consent

Exclusion criteria

Exclusion Criteria:

  • Smoking habit
  • Systemic diseases or use of systemic drugs
  • Parafunctional habits such as bruxism
  • Preoperative pain
  • Teeth requiring prosthetic restoration
  • Teeth with external or internal resorption
  • Immature teeth
  • Periodontal probing depth > 3 mm
  • Pregnant women
  • Women with irregular menstrual cycles
  • Patients who refuse to participate
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
99 participants (actual)
Patient registry
No

Interventions

  • Procedureroot canal treathment

    All participants underwent standard root canal treatment under local anesthesia and rubber dam isolation. Root canals were prepared using ProTaper Next rotary files, irrigated with 2.5% sodium hypochlorite and 17% EDTA, dried with paper points, and filled using a sealant and gutta-percha. The teeth were then restored coronally with composite resin. Postoperative pain and analgesic use were monitored for 72 hours to assess the influence of menstrual cycle phase on pain perception. This standardized procedure ensures consistency across participants and allows comparisons between menstrual phases and between male patients.

05

What researchers measure

Primary outcomes

  1. Post-Endodontic Pain Intensity

    Measured using Visual Analog Scale (VAS) at 8 hours, 8-24 hours, 24-48 hours, and 48-72 hours after root canal treatment. Participants self-recorded the highest pain intensity at each time point.

    Time frame: Up to 72 hours post-treatment.

06

Study locations

1 site
  • Recep Tayyip Erdoğan Univercity
    Rize, 53020, Turkey (Türkiye)
07

References and documents

Related links

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07291518
Lead sponsor
Ahter Sanal Cikman
Responsible party
Ahter Sanal Cikman (Principal Investigator (PI), Assistant Professor of Endodontics, Recep Tayyip Erdogan University) — Sponsor-investigator
First posted
Dec 18, 2025
Start date
Sep 1, 2023
Primary completion
Jan 15, 2025
Completion
Jan 30, 2025
Last update
Dec 26, 2025

Study contacts

Merve Çoban Öksüzer
principal investigator · pamukkale univercity
Ömer Hatipoğlu
study director · recep tayyip erdoğan univercity
Fatma Pertek Hatipoğlu
study director · recep tayyip erdoğan univercity
ahter şanal çıkman
study director · recep tayyip erdoğan univercity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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