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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06886243
Enrollment
35
Registered
2025-03-20
Start date
2022-08-01
Completion date
2023-06-30
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Composite Restorations, Menstrual Cycle, Postoperative Sensitivity, Rebound Pain

Brief 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.

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.

Interventions

PROCEDUREDirect Posterior Composite Restoration

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).

Sponsors

Firat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Both the operator performing the restorations and the researcher assessing postoperative sensitivity and rebound pain were blinded to the menstrual cycle phases of the participants.

Intervention model description

This study is designed as a double-blind, split-mouth, randomized clinical trial. Each participant undergoes two direct posterior composite restorations in different menstrual cycle phases.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Sensitivity (POS) Score Measured Using Visual Analog Scale (VAS)Day 1, Day 2, and Day 3 after restorationPostoperative 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.

Secondary

MeasureTime frameDescription
Rebound Pain (RP) Score Measured Using Visual Analog Scale (VAS)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026