An Evaluation of the Relationship Between Sleep Quality and Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI) score
研究概览
简要总结
This project aims to investigate the relationship between periodontitis and sleep quality. Its originality lies in evaluating the association between periodontal status and sleep quality together with salivary interleukin-6 (IL-6), interleukin-6 (IL-10) IL-10, and pentraxin-3 levels. In particular, examining the relationship of sleep quality with biological, psychological, and lifestyle factors through periodontitis and salivary IL-6, IL-10, and pentraxin-3 levels has not been previously studied in the literature. Methodologically, periodontal status will be determined through clinical examination; participants' Pittsburgh Sleep Quality Index and Multidimensional Fatigue Inventory scores will be recorded; and salivary IL-6, IL-10, and pentraxin-3 levels will be measured. The obtained data will be compared using statistical analyses to determine the strength of the relationship between periodontitis severity and sleep quality. From a management perspective, the project will be conducted following approval from the ethics committee. In terms of broader impact, the results are expected to scientifically demonstrate the relationship between periodontitis and sleep quality, contribute to the adoption of a holistic health approach in clinical practice, and increase public health awareness. Additionally, the project is expected to provide a foundation for future research on the relationship between oral health and quality of life.
详细描述
This study is designed to investigate the relationship between periodontitis and sleep quality through clinical, questionnaire-based, and biochemical parameters. Periodontitis is a chronic inflammatory disease that may influence systemic health, while sleep quality is closely associated with inflammatory, psychological, and lifestyle-related factors. However, the combined evaluation of periodontal status, sleep quality, and salivary inflammatory biomarkers has not been sufficiently explored.
Participants will undergo a comprehensive periodontal examination, including standard clinical periodontal parameters, to determine periodontal status and disease severity. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and fatigue status will be evaluated with the Multidimensional Fatigue Inventory (MFI). These validated instruments will provide quantitative measures of subjective sleep quality and fatigue dimensions.
In addition to clinical and questionnaire data, unstimulated saliva samples will be collected from all participants under standardized conditions. Salivary levels of interleukin-6 (IL-6), interleukin-10 (IL-10), and pentraxin-3 will be measured using appropriate biochemical analysis methods. These biomarkers are selected to reflect inflammatory and immunoregulatory activity potentially linking periodontal disease and sleep disturbances.
The primary objective is to determine whether sleep quality is associated with periodontal disease severity. Secondary objectives include evaluating the relationship between sleep quality scores, fatigue measures, and salivary inflammatory marker levels. Statistical analyses will be performed to assess correlations and group differences among periodontal, sleep, and biomarker variables.
The study will be conducted following ethics committee approval and in accordance with relevant ethical guidelines. Findings are expected to contribute to a better understanding of the biological and behavioral links between oral health and sleep quality and to support a more holistic approach in clinical health assessment and preventive care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy,
- •clinical diagnosis of periodontitis,
- •clinical diagnosis of periodontal health
排除标准
- •history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 6 months);
- •nonsurgical periodontal treatment (previous 6 months);
- •surgical periodontal treatment (previous 12 months);
- •presence of <20 teeth;
- •current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy);
- •diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, or excessive alcohol consumption.
研究组 & 干预措施
Case Group
Within the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and have periodontitis will be included.
干预措施: Periodontal examinations (Diagnostic Test)
Case Group
Within the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and have periodontitis will be included.
干预措施: Collection of saliva samples (Diagnostic Test)
Case Group
Within the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and have periodontitis will be included.
干预措施: Pittsburgh Sleep Quality Index (Diagnostic Test)
Case Group
Within the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and have periodontitis will be included.
干预措施: (Multidimensional Assessment of Fatigue (Diagnostic Test)
Control Group
Within the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and do not have periodontal disease will be included.
干预措施: Periodontal examinations (Diagnostic Test)
Control Group
Within the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and do not have periodontal disease will be included.
干预措施: Collection of saliva samples (Diagnostic Test)
Control Group
Within the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and do not have periodontal disease will be included.
干预措施: Pittsburgh Sleep Quality Index (Diagnostic Test)
Control Group
Within the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and do not have periodontal disease will be included.
干预措施: (Multidimensional Assessment of Fatigue (Diagnostic Test)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI) score
时间窗: At baseline (single visit)
The Pittsburgh Sleep Quality Index (PSQI) is a standardized self-report instrument used to evaluate and measure an individual's sleep quality over the past month. It is widely used in both clinical and research settings to identify sleep disturbances in patient populations, assess sleep quality in healthy individuals, and examine various variables related to sleep. The scale consists of 4 questions that assess sleep habits over the past month using time-based responses, 12 questions that measure the frequency of specific sleep problems if present, and 1 question that provides an overall evaluation of sleep quality during the last month. The PSQI measures sleep quality across multiple dimensions, including subjective sleep quality, sleep latency (time to fall asleep and difficulty initiating sleep), sleep duration, habitual sleep efficiency (the ratio of time spent asleep to time spent in bed), sleep disturbances (such as frequent awakenings, snoring, nocturia, and nightmares), use of
Multidimensional Assessment of Fatigue (MAF) Scale
时间窗: At baseline (single visit)
The MAF Scale is a self-report instrument developed to evaluate individuals' fatigue experiences over the past seven days. It is based on personal perception and subjective reporting and can be administered in a short time. The scale consists of 16 items and covers five dimensions: degree of fatigue (item 1), severity (item 2), distress caused by fatigue (item 3), impact on activities of daily living (items 4-14), and timing/frequency (items 15-16). Items 1-14 use a 1-10 numeric rating format, while items 15-16 are multiple-choice questions. Participants may indicate if they did not perform certain activities for reasons other than fatigue; such items are excluded from scoring. The MAF scale is widely used to provide a multidimensional evaluation of fatigue, particularly in chronic diseases. In clinical research, it is used to monitor the effects of treatment or rehabilitation on fatigue, to evaluate symptom changes during patient follow-up, and to assess quality of life. In the scori
Clinical Attachment Level (mm)
时间窗: At baseline (single visit)
Clinical attachment level (CAL) is a more reliable indicator of periodontal support around a tooth than probing depth alone, as it is measured from a fixed anatomical landmark-the cementoenamel junction (CEJ)-which remains constant over time. Calculating CAL requires two measurements: the distance from the gingival margin to the CEJ and the probing depth. In cases of gingival recession, CAL is calculated by adding the probing depth to the distance from the gingival margin to the CEJ. In cases of gingival overgrowth, CAL is determined by subtracting the distance from the gingival margin to the CEJ from the probing depth.
Salivary pentraxin-3 levels
时间窗: Baseline
Salivary pentraxin levels. Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. Pentraxin levels in saliva will be measured using the ELISA method.
次要结局
- Plaque Index(At baseline (single visit))
- Plaque percentage(At baseline (single visit))
- Gingival Index(At baseline (single visit))
- Probing Pocket Depth(At baseline (single visit))
- Bleeding on Probing(At baseline (single visit))
- Salivary interleukin-10 (IL-10) levels(Baseline)
- Salivary interleukin-6 (IL-6) levels(Baseline)
研究者
Ayşegül Ayça Sarıkaya
Principal Investigator
Uskudar University