Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Starting soon
Conditions studied: Gingivitis, Circadian Rhythm Disruption, Periodontal Inflammation, Circadian Rhythm Sleep Disorder, Shift Work Type
In brief
This prospective cross-sectional clinical study aims to investigate the relationship between circadian rhythm disruption and periodontal inflammation by evaluating circadian clock protein levels, inflammatory (IL-1beta) and anti-inflammatory (IL-10) cytokine levels in gingival crevicular fluid (GCF) of individuals with and without circadian rhythm disruption. Participants aged 20-50 years will be classified into four groups based on their circadian rhythm status (disrupted/normal) and gingival health status (gingivitis/healthy). Clinical periodontal parameters including plaque index, gingival index, bleeding on probing, and probing depth will be assessed. Circadian rhythm status will be determined using validated questionnaires (Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire). Night-shift workers will represent the circadian rhythm disruption group. GCF samples will be analyzed for circadian clock proteins (BMAL-1, CLOCK, PER-1, PER-2, PER-3, CRY-1, CRY-2, REV-ERB-beta, MTNR1B) and cytokines (IL-1beta, IL-10) using ELISA. Serum cortisol and melatonin levels will be measured for biochemical verification of circadian rhythm status. Gingivitis groups will receive standard periodontal treatment and be re-evaluated at 2 weeks post-treatment. A total of 116 participants (29 per group) are planned for enrollment.
Key facts
- Study ID
- NCT07592052
- Run by
- Inonu University
- People needed
- 116
- Starts
- 2026-08-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 20 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Aged between 20 and 50 years
- Systemically healthy
- Diagnosed as periodontally healthy or with gingivitis based on clinical periodontal examination
- Having at least 20 natural teeth in the oral cavity
- Willing to provide written informed consent
- Agreeing to participate in circadian rhythm assessment and completing the Morningness-Eveningness Questionnaire (MEQ) and Munich Chronotype Questionnaire (MCTQ)
- Sleep duration of 6-9 hours per day
- For periodontally healthy: PD <=3 mm, BOP <10%, CAL=0, no radiographic bone loss
- For gingivitis: PD <=3 mm, 10%<=BOP<=30%, CAL=0, no radiographic bone loss
- For circadian rhythm disruption group: being a night-shift worker
You may not qualify if…
- Use of antioxidant or melatonin supplements
- Presence of any systemic disease
- Use of antibiotics, anti-inflammatory drugs, or immunosuppressants within the past 3 months
- Having received periodontal treatment within the past 6 months
- Pregnancy or lactation
- Use of tobacco or tobacco products
- Presence of acute oral infection, abscess, or advanced periodontal disease
- Currently undergoing orthodontic treatment or having fixed orthodontic appliances
- Inability to comply with study procedures or refusal to provide informed consent
- Self-reported sleep duration less than 6 hours or greater than 9 hours per day
Where it is running
- Inönü University Faculty of Dentistry, Department of Periodontology — Malatya, Malatya, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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