About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Systemically healthy volunteers aged 20-50 years presenting to Inonu University Faculty of Dentistry, Department of Periodontology. The study population includes individuals with normal circadian rhythm and night-shift workers with circadian rhythm disruption. Participants are classified as periodontally healthy or with gingivitis based on clinical periodontal examination. Circadian rhythm status is verified using the Morningness-Eveningness Questionnaire (MEQ) and Munich Chronotype Questionnaire (MCTQ).
Trial design
Case-control
Prospective
Treatments tested in this trial
Standard Periodontal Treatment
Other interventionStandard periodontal treatment including detailed oral hygiene instruction and professional dental surface cleaning (scaling and polishing). Applied to gingivitis groups (Group 2 and Group 4) at baseline, with clinical and biochemical re-evaluation at 14 days post-treatment.
Treatment groups
Trial outcomes
Primary outcomes
GCF Circadian Rhythm Protein Levels
Concentrations of circadian clock proteins (BMAL-1, CLOCK, PER-1, PER-2, PER-3, CRY-1, CRY-2, REV-ERB-beta, MTNR1B) measured in gingival crevicular fluid (GCF) using ELISA. GCF collected with Periopaper strips placed in the gingival sulcus for 30 seconds. Volumes quantified using a Periotron device.
GCF Inflammatory Cytokine Levels
Interleukin-1 beta (IL-1beta, pro-inflammatory) and Interleukin-10 (IL-10, anti-inflammatory) cytokine concentrations in gingival crevicular fluid measured by ELISA.
Sponsors and contacts
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Inonu University
Lead sponsor
University of Minnesota
Collaborator
Harvard University
Collaborator
University of Turku
Collaborator
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