Pain Perception in Endodontic TreatmentNCT07850167
Menstrual Cycle, Menopause, and Pain Perception During Endodontic Treatment
An observational study of Pain Perception in Endodontic Treatment and Menstrual Cycle, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Perception in Endodontic Treatment, Menstrual Cycle, Menopause
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Willing to participate in the study
- Aged 18 years or older
- Having at least one tooth requiring root canal treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Niğde Omer Halisdemir University
Niğde
Zübeyde Gökçe Ürün, Assistant Professor, +905378880030, gurun@ohu.edu.tr
About this study
Official title: Effects of Menstrual Cycle Phases and Menopause on Pain Perception in Endodontic Therapy
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: -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
Dental anxiety will be assessed using the 5-item Modified Dental Anxiety Scale (MDAS), with total scores ranging from 5 to 25. Higher scores indicate greater dental anxiety. Scores will be evaluated among participants in the follicular phase, luteal phase, and postmenopausal groups.
Measured: Before endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start10 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Perception in Endodontic TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zübeyde Gökçe ÜRÜN, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850167
- Sponsor's protocol ID
- 2026/10
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Menstrual Cycle Phases and Menopause on Pain Perception in Endodontic Therapy
- ClinicalTrials.gov ID
- NCT07850167
- Acronym / sponsor ID
- 2026/10
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Willing to participate in the study
- Aged 18 years or older
- Having at least one tooth requiring root canal treatment
Key exclusion criteria (6 listed)
- Aged under 18 years
- No tooth requiring root canal treatment
- Male sex
- Diagnosis of endometriosis or polycystic ovary syndrome (PCOS)
- Use of oral contraceptives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Intensity Assessed Using the Visual Analog Scale
Time frame: -Before treatment(baseline) -Immediately after local anesthetic injection -Immediately after completion of endodontic treatment -Postoperative Day 1 -Postoperative Day 2
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.
1 secondary outcome
Dental Anxiety Assessed Using the Modified Dental Anxiety Scale
Time frame: Before endodontic treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Perception in Endodontic Treatment and Menstrual Cycle, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zübeyde Gökçe Ürün, Assistant Professor (+905378880030, gurun@ohu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Assessed Using the Visual Analog Scale (time frame: -Before treatment(baseline) -Immediately after local anesthetic injection -Immediately after completion of endodontic treatment -Postoperative Day 1 -Postoperative Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.