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Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption (Nursma-CIRC-HG)

2026年5月11日 更新者:Cuneyt Asim Aral、Inonu University

Investigation of Circadian Clock Gene/Proteins in Individuals With and Without Disrupted Circadian Rhythm: A Prospective Cross-Sectional Clinical Study

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.

調査の概要

詳細な説明

Gingival tissue plays a critical role in maintaining oral health as a fundamental component of periodontal tissues. Recent evidence suggests that circadian rhythm mechanisms, beyond microbial factors, may significantly influence periodontal disease pathogenesis through modulation of host immune responses.

The circadian rhythm is an endogenous mechanism regulating biological processes in approximately 24-hour physiological and behavioral cycles, controlled centrally by the suprachiasmatic nucleus in the hypothalamus. At the molecular level, core clock genes (CLOCK, BMAL1, PER1-3, CRY1-2) operate through the Transcription-Translation Feedback Loop (TTFL). CLOCK and BMAL1 proteins form heterodimers in the cell nucleus, bind to E-box regions on DNA, and initiate transcription of PER and CRY genes. Subsequently, PER and CRY proteins synthesized in the cytoplasm return to the nucleus and inhibit the CLOCK-BMAL1 complex, creating approximately 24-hour rhythmic gene expression cycles. Regulatory nuclear receptors such as REV-ERBa and ROR also contribute to the fine-tuning of this mechanism.

Recent studies have demonstrated the presence of functional peripheral clock mechanisms in periodontal tissues. CLOCK, BMAL1, PER1-3, and CRY1-2 gene expression has been identified in gingival fibroblasts and periodontal ligament fibroblasts. Experimental studies have shown that circadian rhythm disruption can increase inflammatory processes, enhance macrophage activation, elevate inflammatory cytokine production, and accelerate alveolar bone loss in periodontitis models.

Despite these findings, human studies evaluating the relationship between inflammatory cytokines and circadian rhythm proteins in gingival crevicular fluid (GCF) remain limited. This study addresses this gap by evaluating gingival health status using clinical periodontal parameters in individuals with and without circadian rhythm disruption.

Study Design:

Participants will be classified into four groups based on circadian rhythm status and periodontal health:

  • Group 1: Normal circadian rhythm / Periodontally healthy (control)
  • Group 2: Normal circadian rhythm / Gingivitis
  • Group 3: Circadian rhythm disruption / Periodontally healthy
  • Group 4: Circadian rhythm disruption / Gingivitis
  • Group 5: Group 2 at 2 weeks post-periodontal treatment
  • Group 6: Group 4 at 2 weeks post-periodontal treatment

Time Points:

T0 (Baseline): Clinical periodontal examination, GCF, saliva, and serum sampling in all groups.

T1 (Day 14): Re-evaluation of clinical parameters and biological sampling in gingivitis groups after standard periodontal treatment.

Clinical Periodontal Assessment:

All periodontal measurements will be performed by a single examiner using a standard periodontal probe at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual). Parameters include plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL).

GCF Sampling:

GCF samples will be collected using sterile Periopaper strips placed in the gingival sulcus for 30 seconds after supragingival plaque removal and isolation. GCF volumes will be quantified using a Periotron device. Samples contaminated with blood will be excluded.

Saliva Sampling:

Unstimulated saliva samples will be collected as an alternative biological material if circadian rhythm proteins cannot be detected at sufficient levels in GCF.

Serum Sampling:

Venous blood samples will be collected from the antecubital vein for biochemical evaluation of circadian rhythm status through cortisol and melatonin level analysis.

All biological samples will be collected during standardized morning hours (09:00-11:00) to minimize diurnal variation in biomarker levels.

Laboratory Analysis:

GCF samples will be analyzed using ELISA for circadian rhythm-related proteins (MTNR1B, BMAL-1, CLOCK, PER-1, PER-2, PER-3, CRY-1, CRY-2, REV-ERB-beta) and inflammatory biomarkers (IL-1beta and IL-10).

Statistical Analysis:

Data will be analyzed using SPSS. Normality will be assessed by Shapiro-Wilk test. Comparisons among independent groups will use one-way ANOVA or Kruskal-Wallis test, with Tukey or Dunn post-hoc tests. Pre- and post-treatment comparisons will use paired t-test or Wilcoxon signed-rank test. Correlations will be assessed by Pearson or Spearman analysis. Multivariate regression models will control for age, sex, BMI, and waist circumference as covariates. Significance level: p < 0.05.

This study was approved by the Inonu University Health Sciences Scientific Research Ethics Committee and will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants.

研究の種類

観察的

入学 (推定)

116

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Cüneyt A Aral, Chair, Professor Dr, DDS, PhD
  • 電話番号:+905424577657
  • メール:cuneytasimaral@gmail.com

研究連絡先のバックアップ

  • 名前:Kübra Aral, Assoc. Professor, DDS, PhD
  • 電話番号:+905330578801
  • メール:drkubraaral@gmail.com

研究場所

    • Malatya
      • Malatya、Malatya、トルコ(Türkiye)、44210
        • Inönü University Faculty of Dentistry, Department of Periodontology

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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).

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Normal Circadian / Periodontally Healthy
Individuals with normal circadian rhythm and periodontal health (control group). Inclusion: PD <=3 mm, BOP <10%, CAL=0, no radiographic bone loss. n=29
Normal Circadian / Gingivitis
Individuals with normal circadian rhythm and gingivitis. Inclusion: PD <=3 mm, 10%<=BOP<=30%, CAL=0, no radiographic bone loss. These participants will receive standard periodontal treatment and be re-evaluated at 14 days post-treatment. n=29
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.
Disrupted Circadian / Periodontally Healthy
Night-shift workers with circadian rhythm disruption and periodontal health. Circadian rhythm status verified by MEQ and MCTQ questionnaires. Inclusion: PD <=3 mm, BOP <10%, CAL=0, no radiographic bone loss. n=29
Disrupted Circadian / Gingivitis
Night-shift workers with circadian rhythm disruption and gingivitis. Circadian rhythm status verified by MEQ and MCTQ questionnaires. Inclusion: PD <=3 mm, 10%<=BOP<=30%, CAL=0, no radiographic bone loss. These participants will receive standard periodontal treatment and be re-evaluated at 14 days post-treatment. n=29
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
GCF Circadian Rhythm Protein Levels
時間枠: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.
Baseline (T0) and 14 days post-treatment (T1) for gingivitis groups
GCF Inflammatory Cytokine Levels
時間枠: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.
Baseline (T0) and 14 days post-treatment (T1) for gingivitis groups

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディチェア:Cüneyt A Aral, Professor, DDS, PhD、Inonu University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2027年1月1日

研究の完了 (推定)

2027年3月1日

試験登録日

最初に提出

2026年5月11日

QC基準を満たした最初の提出物

2026年5月11日

最初の投稿 (実際)

2026年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月18日

QC基準を満たした最後の更新が送信されました

2026年5月11日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IUCREC.2026/9750
  • Will be applied (その他の助成金/資金番号:Inönü University Scientific Research Projects Coordination Office)

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