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.
Who can participate
Age range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
GCF Circadian Rhythm Protein Levels
Timeframe: Baseline (T0) and 14 days post-treatment (T1) for gingivitis groups
2
GCF Inflammatory Cytokine Levels
Timeframe: Baseline (T0) and 14 days post-treatment (T1) for gingivitis groups