Menstrual Cycle Effects on Postoperative Sensitivity and Rebound Pain in Composite Restorations
Effect of Menstrual Cycle on Postoperative Sensitivity and Rebound Pain in Posterior Composite Restorations: A Double-Blind Split-Mouth Clinical Study
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
This clinical trial investigates the effect of menstrual cycle phases on postoperative pain perception following direct posterior composite restorations. It addresses the hypothesis that hormonal fluctuations during the menstrual cycle may alter pain thresholds and nociceptive processing, potentially influencing the intensity and timing of postoperative dental pain.
Estrogen and progesterone, the primary hormones involved in the menstrual cycle, have been shown to modulate pain through their effects on the central and peripheral nervous systems, inflammatory mediators, and endogenous opioid pathways. Despite extensive research on hormonal influences in systemic pain, their specific effects on dental pain-particularly postoperative sensitivity and rebound pain-remain understudied.
The study employed a double-blind, split-mouth, randomized clinical design to minimize inter-subject variability and strengthen internal validity. A total of 35 female participants with regular menstrual cycles underwent two posterior Class II composite restorations, one during the menstrual phase (MPG) and one during the ovulatory phase (OPG). Menstrual phases were confirmed using self-reported cycle calendars and mobile tracking applications.
All restorative procedures were standardized and performed under local anesthesia. Composite restorations were completed using Clearfil Majesty Posterior and Clearfil Universal Bond Quick (self-etch mode). An inferior alveolar nerve block (IANB) was administered using articaine hydrochloride with epinephrine (1:100,000).
Pain was assessed using the Visual Analog Scale (VAS, 0-10) at predefined time points to evaluate two types of postoperative discomfort:
Postoperative Sensitivity (POS): assessed on Day 1, Day 2, and Day 3 following the procedure.
Rebound Pain (RP): assessed at Hour 4, Hour 8, and Hour 12 after the resolution of anesthesia.
Statistical analyses were performed using Cochran's Q test and McNemar's test for within-subject comparisons, and Chi-Square or Fisher's Exact Test for between-group differences. Bonferroni correction was applied for multiple comparisons to control type I error, with p < 0.05 considered statistically significant.
This study provides new insights into the chronobiological factors affecting dental pain and contributes to the evidence base for individualized pain management in female dental patients. The findings may support more personalized scheduling of restorative procedures and better prediction of analgesic needs based on menstrual cycle phases.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Elazıg, Turkey, 23200
- Firat University Faculty of Dentistry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Menstrual Phase Group (MPG)
Arm 1: Menstrual Phase Group (MPG) Arm Type: Experimental Arm Name: Menstrual Phase Group (MPG) Description: Participants receive a direct posterior composite restoration during the menstrual phase of their cycle.
Postoperative sensitivity (POS) and rebound pain (RP) are assessed at multiple time points.
|
Description: Composite restorations performed using Clearfil Majesty Posterior (Kuraray, Japan) and Clearfil Universal Bond Quick (Kuraray, Japan) in self-etch mode. Inferior alveolar nerve block (IANB) administered with articaine hydrochloride with epinephrine (1:100,000) (Maxicaine). |
|
Experimental: Ovulatory Phase Group (OPG)
Arm 2: Ovulatory Phase Group (OPG) Arm Type: Experimental Arm Name: Ovulatory Phase Group (OPG) Description: Participants receive a direct posterior composite restoration during the ovulatory phase of their cycle.
POS and RP are assessed at multiple time points.
|
Description: Composite restorations performed using Clearfil Majesty Posterior (Kuraray, Japan) and Clearfil Universal Bond Quick (Kuraray, Japan) in self-etch mode. Inferior alveolar nerve block (IANB) administered with articaine hydrochloride with epinephrine (1:100,000) (Maxicaine). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Sensitivity (POS) Score Measured Using Visual Analog Scale (VAS)
Time Frame: Day 1, Day 2, and Day 3 after restoration
|
Postoperative sensitivity (POS) is assessed using the Visual Analog Scale (VAS, 0-10). A score of 0 represents no pain/sensitivity, while 10 represents unbearable pain/sensitivity. Clinically significant postoperative sensitivity is defined as VAS ≥4. Measurements are recorded at 24, 48, and 72 hours after the restoration. Description: Postoperative sensitivity (POS) will be evaluated using the Visual Analog Scale (VAS, 0-10), where 0 represents no pain/sensitivity and 10 represents unbearable pain/sensitivity. Sensitivity will be recorded at 24, 48, and 72 hours postoperatively. A VAS score ≥4 will be considered clinically significant. |
Day 1, Day 2, and Day 3 after restoration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rebound Pain (RP) Score Measured Using Visual Analog Scale (VAS)
Time Frame: Hour 4, Hour 8, and Hour 12 after anesthesia resolution.
|
Rebound pain (RP) is assessed using the Visual Analog Scale (VAS, 0-10) at predefined intervals after the anesthetic effect resolves. A score of 0 represents no pain, while 10 represents the worst pain experienced. Clinically significant rebound pain is defined as VAS ≥4. Measurements are recorded at 4, 8, and 12 hours postoperatively after anesthesia resolution. |
Hour 4, Hour 8, and Hour 12 after anesthesia resolution.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIRAT-DENTISTRY ADEMGOK-001
- 1919B012224148 (Other Grant/Funding Number: TUBİTAK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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