Investigation of the Relationship Between Periodontitis and Sleep Quality

Официальное название

An Evaluation of the Relationship Between Sleep Quality and Periodontitis

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Periodontal examinations
  With periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, gingival index, plaque index, number of teeth parameters are recorded.
• Диагностический тест Collection of saliva samples
  Levels of salivary interleukin-10 (IL-10), interleukin-6 (IL-6), pentraxin-3 will be determined using an enzyme-linked immunosorbent assay (ELISA).
• Диагностический тест Pittsburgh Sleep Quality Index
  The Pittsburgh Sleep Quality Index (PSQI) is a standardized self-report tool used to measure sleep quality over the past month. It is widely applied in both clinical and research settings to screen for sleep disorders, evaluate sleep quality in healthy and patient populations, and analyze sleep-related factors. The scale includes questions on sleep habits, frequency of sleep problems, and overall sleep quality. It assesses multiple dimensions: subjective sleep quality, sleep latency, sleep durat
• Диагностический тест (Multidimensional Assessment of Fatigue
  The MAF Scale (Multidimensional Assessment of Fatigue) is a self-reported instrument developed to evaluate individuals' fatigue experiences over the past seven days, based on personal perceptions. It consists of 16 items and can be administered in a short time. The scale 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 numerical r

Первичные конечные точки

• Pittsburgh Sleep Quality Index (PSQI) score [Срок оценки: At baseline (single visit)]
• Multidimensional Assessment of Fatigue (MAF) Scale [Срок оценки: At baseline (single visit)]
• Clinical Attachment Level (mm) [Срок оценки: At baseline (single visit)]
• Salivary pentraxin-3 levels [Срок оценки: Baseline]

Вторичные конечные точки (7)

• Plaque percentage [Срок оценки: At baseline (single visit)]
• Gingival Index [Срок оценки: At baseline (single visit)]
• Probing Pocket Depth [Срок оценки: At baseline (single visit)]
• Bleeding on Probing [Срок оценки: At baseline (single visit)]
• Salivary interleukin-10 (IL-10) levels [Срок оценки: Baseline]
• Salivary interleukin-6 (IL-6) levels [Срок оценки: Baseline]
• Plaque Index [Срок оценки: At baseline (single visit)]

Критерии участия

Критерии включения

• systemically healthy,
• clinical diagnosis of periodontitis,
• clinical diagnosis of periodontal health

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Uskudar University — Istanbul

Идентификаторы

NCT: NCT07421960 · ASARIKAYA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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