NCT07291518

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

December 5, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

Endodontic treatmentPost-endodontic painPain perceptionMandibular molarsDental painpostoperative painMenstrual cycle

Outcome Measures

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.

    Up to 72 hours post-treatment.

Interventions

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.

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdoğan Univercity

Rize, 53020, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

ToothachePain, Postoperative

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Merve Çoban Öksüzer

    pamukkale univercity

    PRINCIPAL INVESTIGATOR
  • Ömer Hatipoğlu

    recep tayyip erdoğan univercity

    STUDY DIRECTOR
  • Fatma Pertek Hatipoğlu

    recep tayyip erdoğan univercity

    STUDY DIRECTOR
  • ahter şanal çıkman

    recep tayyip erdoğan univercity

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator (PI), Assistant Professor of Endodontics

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

September 1, 2023

Primary Completion

January 15, 2025

Study Completion

January 30, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations