Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-50
SponsorInonu University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Standard Periodontal Treatment

    Other intervention

    Standard 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

116 Participants
are divided into 4 treatment groups
Group A: Normal Circadian / Periodontally Healthy0 interventions
Group B: Normal Circadian / Gingivitis1 intervention
Group C: Disrupted Circadian / Periodontally Healthy0 interventions
Group D: Disrupted Circadian / Gingivitis1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (T0) and 14 days post-treatment (T1) for gingivitis groups
2

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.

Time frame
Baseline (T0) and 14 days post-treatment (T1) for gingivitis groups

Secondary outcomes

Other outcomes

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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