Menstrual Cycle Effects on Postoperative Sensitivity and Rebound Pain in Composite Restorations (NCT06886243) | Clinical Trial Compass
CompletedNot Applicable
Menstrual Cycle Effects on Postoperative Sensitivity and Rebound Pain in Composite Restorations
Turkey (Türkiye)35 participantsStarted 2022-08-01
Plain-language summary
This study aims to evaluate how different phases of the menstrual cycle affect pain after dental treatments. Specifically, it investigates two types of pain:
Postoperative sensitivity (pain felt after the filling procedure), and Rebound pain (pain that begins after the numbness from anesthesia wears off). The study was conducted with 35 women who received two dental fillings at different times in their cycle: once during the menstrual phase and once during the ovulatory phase.
A local anesthetic (inferior alveolar nerve block) was used before treatment, and pain was measured using a 0-10 visual scale at several time points after the procedure.
The goal of the study is to understand whether hormonal changes during the menstrual cycle can affect pain levels after dental work. This information could help dentists improve pain management strategies for women and personalize treatment timing.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female participants aged 18-45 years
* Regular naturally occurring menstrual cycles (26-32 days)
* No use of hormonal contraceptives
* Good general health
* Vital posterior molar teeth requiring direct composite restorations
* Good oral hygiene and periodontal health
Exclusion Criteria:
* Irregular menstrual cycles or known hormonal disorders
* Presence of dentin hypersensitivity in the affected tooth
* Regular use of psychiatric or other medications
* History of bruxism, temporomandibular disorders (TMD), or chronic pain syndromes Pregnancy or lactation
* Use of analgesics, oral contraceptives, or anti-inflammatory drugs within 48 hours before treatment
* Severe periodontal disease, dental pain, or need for endodontic treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Sensitivity (POS) Score Measured Using Visual Analog Scale (VAS)
Timeframe: Day 1, Day 2, and Day 3 after restoration