Relationship Between Gum Disease and Sleep Quality
An Evaluation of the Relationship Between Sleep Quality and Periodontitis
Uskudar University · NCT07421960
This project will see if periodontitis and saliva inflammation markers (IL-6, IL-10, pentraxin-3) are linked to poorer sleep quality and greater fatigue in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Uskudar University (other) |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07421960 on ClinicalTrials.gov |
What this trial studies
This observational project combines clinical periodontal exams, validated sleep and fatigue questionnaires, and salivary biomarker measurements to explore links between gum disease and sleep quality. Periodontal status will be determined with standard clinical periodontal parameters, while sleep and fatigue will be measured using the Pittsburgh Sleep Quality Index and the Multidimensional Fatigue Inventory. Unstimulated saliva samples will be collected under standardized conditions and analyzed for IL-6, IL-10, and pentraxin-3 concentrations. Statistical analyses will compare periodontal severity, biomarker levels, and questionnaire scores to quantify the strength of their relationships.
Who should consider this trial
Good fit: Systemically healthy adults who either have clinically diagnosed periodontitis or normal periodontal health, have at least 20 teeth, and meet medication and recent-treatment criteria are the ideal candidates.
Not a fit: People with diabetes, rheumatoid arthritis, recent periodontal surgery or nonsurgical treatment, recent regular antibiotic or anti-inflammatory use, certain gingiva-affecting medications, pregnancy or lactation, excessive alcohol use, or fewer than 20 teeth are unlikely to qualify or benefit from participation.
Why it matters
Potential benefit: If successful, the findings could identify salivary biomarkers that help explain or predict sleep problems in people with periodontitis and guide future interventions.
How similar studies have performed: Previous research has linked periodontal disease and systemic inflammation to poor sleep, but the combined assessment of periodontal status, sleep quality, and salivary IL-6, IL-10, and pentraxin-3 in the same participants is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * systemically healthy, * clinical diagnosis of periodontitis, * clinical diagnosis of periodontal health Exclusion Criteria: * 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.
Where this trial is running
Istanbul, Istanbul
- Uskudar University — Istanbul, Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Ayşegül Ayça Sarıkaya, Principal Investigator
- Email: aysegulaycas@gmail.com
- Phone: +905050951478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Periodontitis, Periodontal Disease, Sleep Quality, Fatigue, IL-6, IL-10, pentraxin, periodontitis