NCT07421960

Investigation of the Relationship Between Periodontitis and Sleep Quality

An Evaluation of the Relationship Between Sleep Quality and Periodontitis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 48 (estimated)
• Sponsor: Uskudar University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Periodontitis
• Periodontal Disease
• Sleep Quality
• Fatigue

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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).
DIAGNOSTIC_TEST	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 duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item is rated on a four-point frequency scale. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality; scores of 5 or more suggest poor sleep quality. The PSQI is considered a valid and reliable multidimensional assessment instrument.
DIAGNOSTIC_TEST	(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 rating format, while items 15-16 are multiple-choice. Participants may mark a separate option for activities they did not perform due to reasons other than fatigue; such items are excluded from scoring. The MAF scale is particularly used for multidimensional assessment of fatigue in chronic diseases. In clinical research, it is used to monitor the effects of treatment or rehabilitation interventions on fatigue, to evaluate symptom changes during patient follow-up, and to assess quality of life.

Timeline

• Start date: 2026-02-10
• Primary completion: 2026-04-03
• Completion: 2026-05-08
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Turkey (Türkiye)