Investigation of the Relationship Between Periodontitis and Sleep Quality
RBPSQ
An Evaluation of the Relationship Between Sleep Quality and Periodontitis
1 other identifier
observational
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2026
CompletedFirst Submitted
Initial submission to the registry
February 12, 2026
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2026
CompletedFebruary 19, 2026
February 1, 2026
2 months
February 12, 2026
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pittsburgh Sleep Quality Index (PSQI) score
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
At baseline (single visit)
Multidimensional Assessment of Fatigue (MAF) Scale
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
At baseline (single visit)
Clinical Attachment Level (mm)
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.
At baseline (single visit)
Salivary pentraxin-3 levels
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.
Baseline
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
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.
Levels of salivary interleukin-10 (IL-10), interleukin-6 (IL-6), pentraxin-3 will be determined using an enzyme-linked immunosorbent assay (ELISA).
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.
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.
Eligibility Criteria
48
You may qualify if:
- systemically healthy,
- clinical diagnosis of periodontitis,
- clinical diagnosis of periodontal health
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uskudar University
Istanbul, Istanbul, 34764, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 12, 2026
First Posted
February 19, 2026
Study Start
February 10, 2026
Primary Completion
April 3, 2026
Study Completion
May 8, 2026
Last Updated
February 19, 2026
Record last verified: 2026-02