Root Canal TreatmentPEP-MCNCT07291518
Post-Endodontic Pain According to Menstrual Cycle Phases
An observational study of Root Canal Treatment, run by Ahter Sanal Cikman at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Treatment
- What is being tested?
- root canal treathment
- Type of treatment
- Surgery or procedure
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Immature teeth
- Periodontal probing depth > 3 mm
- Pregnant women
- Women with irregular menstrual cycles
- Patients who refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Menstrual Cycle Phases on Post-Endodontic Pain: A Comparative Clinical Study With Male Patients
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.
- Conditions
- Root Canal Treatment
- Being tested
- root canal treathment
- Keywords
- Endodontic treatment, Post-endodontic pain, Pain perception, Mandibular molars, Dental pain, postoperative pain, Menstrual cycle
- Medical subject headings
- Toothache, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal treathmentProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 hours post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Sep 2023
- Primary completion15 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal 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
- Other
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahter Sanal Cikman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahter Sanal Cikman, Recep Tayyip Erdogan University
- Investigators
- Merve Çoban Öksüzer, Principal investigator, pamukkale univercityÖmer Hatipoğlu, Study director, recep tayyip erdoğan univercityFatma Pertek Hatipoğlu, Study director, recep tayyip erdoğan univercityahter şanal çıkman, Study director, recep tayyip erdoğan univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291518
- Sponsor's protocol ID
- MCOBAN-ENDO2025
- Other IDs
- 2023/184 (Ethics Approval)
- Acronym
- PEP-MC
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Menstrual Cycle Phases on Post-Endodontic Pain: A Comparative Clinical Study With Male Patients
- ClinicalTrials.gov ID
- NCT07291518
- Acronym / sponsor ID
- PEP-MC / MCOBAN-ENDO2025
- Conditions
- Root Canal Treatment
- Keywords
- Endodontic treatment, Post-endodontic pain, Pain perception, Mandibular molars, Dental pain, postoperative pain, Menstrual cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Ahter Sanal CikmanUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 18 Dec 2025 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Smoking habit
- Systemic diseases or use of systemic drugs
- Parafunctional habits such as bruxism
- Preoperative pain
- Teeth requiring prosthetic restoration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| root canal treathmentAll 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. | Procedure or surgery | – |
Primary outcome
Post-Endodontic Pain Intensity
Time frame: Up to 72 hours post-treatment.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Merve Çoban Öksüzer principal investigator
pamukkale univercity
Ömer Hatipoğlu study director
recep tayyip erdoğan univercity
Fatma Pertek Hatipoğlu study director
recep tayyip erdoğan univercity
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 Root Canal Treatment, run by Ahter Sanal Cikman 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 26 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Endodontic Pain Intensity (time frame: Up to 72 hours post-treatment.). 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 26 Dec 2025.