Effect of Menstrual Cycle on Postoperative Sensitivity and Rebound Pain in Posterior Composite Restorations: A Double-Blind Split-Mouth Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Postoperative Sensitivity (POS) Score Measured Using Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Postoperative Sensitivity (POS) Score Measured Using Visual Analog Scale (VAS)
时间窗: 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.
次要结局
- Rebound Pain (RP) Score Measured Using Visual Analog Scale (VAS)(Hour 4, Hour 8, and Hour 12 after anesthesia resolution.)
研究者
Adem GOK
DDs, PhD, Assistant Professor
Firat University