Post-Endodontic Pain According to Menstrual Cycle Phases

NCT ID: NCT07291518

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 99 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-01-30

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.

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

Keywords

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

root 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ahter Sanal Cikman

OTHER

Sponsor Role: lead

Responsible Party

Ahter Sanal Cikman

Principal Investigator (PI), Assistant Professor of Endodontics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Merve Çoban Öksüzer

Role: PRINCIPAL_INVESTIGATOR

pamukkale univercity

Ömer Hatipoğlu

Role: STUDY_DIRECTOR

recep tayyip erdoğan univercity

Fatma Pertek Hatipoğlu

Role: STUDY_DIRECTOR

recep tayyip erdoğan univercity

ahter şanal çıkman

Role: STUDY_DIRECTOR

recep tayyip erdoğan univercity

Locations

Recep Tayyip Erdoğan Univercity

Rize, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Related Links

https://www.aae.org/patients/root-canal-treatment/

Related Info

Other Identifiers

2023/184 (Ethics Approval)

Identifier Type: OTHER

Identifier Source: secondary_id

MCOBAN-ENDO2025

Identifier Type: -

Identifier Source: org_study_id