Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Turkey / NCT07592052
Starting soon Observational

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

NCT07592052 · tracked via the Priya Life Science Turkey tracker
Sponsor
Inonu University
Phase
Observational
Started
2026-08-01
Last updated
2026-05-18

Condition(s) studied

GingivitisCircadian Rhythm DisruptionPeriodontal InflammationCircadian Rhythm Sleep Disorder, Shift Work Type

Investigational drug(s) / intervention(s)

Standard Periodontal Treatment

Standard Periodontal Treatment: 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.

Study summary

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

Sex
ALL
Min age
20 Years
Max age
50 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • GCF Circadian Rhythm Protein Levels — Baseline (T0) and 14 days post-treatment (T1) for gingivitis groups
    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 — Baseline (T0) and 14 days post-treatment (T1) for gingivitis groups
    Interleukin-1 beta (IL-1beta, pro-inflammatory) and Interleukin-10 (IL-10, anti-inflammatory) cytokine concentrations in gingival crevicular fluid measured by ELISA.

Trial sites (1)

FacilityCityRegionStatus
Inönü University Faculty of Dentistry, Department of Periodontology Malatya Malatya

More Inonu University trials in Turkey

Effect of Augmented Low-dye* Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus Active, not recruiting
Liver Transplant Recipients and 30-Second Lie-to-Sit Test Recruiting
Blood Parameter Changes Following Aerobic Exercise in Professional Soccer Players Starting soon
The Effect of Web-based Education on Gynecological Cancer Awareness and Healthy Life Behaviors Enrolling by invitation
Nonpharmacological Management of Pain and Fear During Hormone Injection in Breast Cancer Patients Starting soon

Other trials for the same condition

Effect of Morus Nigra Mouthwash on Gingivitis Treatment Recruiting
Evaluation of the Effect of Smoking on Pyroptosis in Periodontal Pathogenesis Active, not recruiting
Evaluation of Gingival Crevicular Fluid Cytokine Profiles in Children and Young Adults With Gingivitis Recruiting
The Effect of Vitamin D Supplementation on the Anti-inflammatory Response in Periodontal Diseases Recruiting
Evaluation of the Effects of Probiotic Toothpastes on Periodontal Health Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07592052 on ClinicalTrials.gov ↗ ← All trials in Turkey