NCT07850167

Brief Summary

The goal of this observational study is to investigate whether menstrual cycle phases and menopausal status are associated with pain perception in patients undergoing endodontic treatment. The main questions it aims to answer are: Does pain experienced during endodontic treatment differ according to the phase of the menstrual cycle? Is pain perception during endodontic treatment different between premenopausal and postmenopausal women? Are menstrual cycle phases and menopausal status associated with pain experienced after endodontic treatment? Participants undergoing endodontic treatment as part of their routine dental care will provide information about their menstrual cycle or menopausal status. Pain will be assessed at different stages of treatment and during the follow-up period after treatment. No treatment will be assigned based on menstrual cycle phase or menopausal status.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress59%
Mar 2026Mar 2027

Study Start

First participant enrolled

March 10, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

September 22, 2026

Last Update Submit

September 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Assessed Using the Visual Analog Scale

    Pain intensity will be assessed using the 100-mm Visual Analog Scale (VAS), ranging from 0 to 100 mm, with higher scores indicating greater pain intensity. Pain scores will be compared among participants in the follicular phase, luteal phase, and postmenopausal groups.

    -Before treatment(baseline) -Immediately after local anesthetic injection -Immediately after completion of endodontic treatment -Postoperative Day 1 -Postoperative Day 2

Secondary Outcomes (1)

  • Dental Anxiety Assessed Using the Modified Dental Anxiety Scale

    Before endodontic treatment

Study Arms (3)

Follicular Phase Group

Women undergoing routine endodontic treatment who are in the follicular phase of their menstrual cycle.

Luteal Phase Group

Women undergoing routine endodontic treatment who are in the luteal phase of their menstrual cycle.

Postmenopausal Group

Postmenopausal women undergoing routine endodontic treatment.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is limited to women because the study investigates the association of menstrual cycle phases and postmenopausal status with pain perception during and after endodontic treatment.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women aged 18 years or older who present to the Department of Endodontics, Faculty of Dentistry, Nigde Omer Halisdemir University and require root canal treatment. Eligible participants who voluntarily agree to participate will be included and classified according to menstrual cycle phase (follicular or luteal phase) or postmenopausal status.

You may qualify if:

  • Willing to participate in the study
  • Aged 18 years or older
  • Having at least one tooth requiring root canal treatment

You may not qualify if:

  • Aged under 18 years
  • No tooth requiring root canal treatment
  • Male sex
  • Diagnosis of endometriosis or polycystic ovary syndrome (PCOS)
  • Use of oral contraceptives
  • Receiving hormone therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Omer Halisdemir University

Niğde, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Zübeyde Gökçe Ürün, Assistant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 30, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations