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临床试验/NCT07504744
NCT07504744尚未招募不适用

Evaluation of the Expression of Klotho Gene and Its Protein Level, Determination of Red Complex Bacteria, and the Estimation of Periodontal Viruses in Patients With and Without Periodontitis and Acute Coronary Syndrome

Meenakshi Ammal Dental College and Hospital0 个研究点目标入组 108 人开始时间: 2026年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
108
主要终点
Changes in periodontal parameters

研究概览

简要总结

The Klotho gene was initially identified as an aging suppressor gene, but subsequent research revealed its multifaceted functions, encompassing antioxidant defense, anti-inflammatory effects, calcium and phosphorus balance, metabolic regulation, and anti-apoptotic activity. It encodes a single pass transmembrane protein and is expressed primarily in renal tubules. The Klotho protein exists in two forms: membrane-bound and secreted. Membrane Klotho acts as a co-receptor for FGF23, a bone-derived hormone, while secreted Klotho regulates various cell surface glycoproteins, including ion channels and growth factor receptors. Klotho has recently emerged as a potential biomarker for coronary heart disease, with evidence suggesting its involvement in the disease's pathophysiology.

The red complex, comprising Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia harbors key pathogens in adult periodontal disease. These bacteria possess various virulence factors, including fimbriae, lipopolysaccharides, and proteases in P. gingivalis, which disrupt inflammatory and immune responses and degrade connective tissue proteins. T. forsythia produces a trypsin-like protease, sialidase, hemagglutinin, and BspA, contributing to alveolar bone loss. Meanwhile, T. denticola disrupts the host cell extracellular matrix, penetrates tissue, and dysregulates immunoregulatory factors, further exacerbating periodontal disease. Similarly, Herpes Simplex Virus 1 (HSV-1), human Cytomegalovirus (HCMV) and Epstein Barr Virus (EBV) have been implicated in the pathogenesis of periodontal disease. The expressions of viruses along the red complex bacteria would provide further evidence of periodontal risk in progression of acute coronary artery disease.

详细描述

The selected subjects will be categorized into the following groups:

GROUP I: Healthy volunteers. GROUP II: Periodontitis patients without acute coronary syndrome. GROUP III: Acute coronary syndrome without periodontitis GROUP IV: Periodontitis and acute coronary syndrome

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients willing to participate in the study.
  • Male and female patients within the age group of 30-65 years.
  • Patients having ≥ 10 remaining natural teeth.
  • No history of long-term antibiotic use in past 6 months.

排除标准

  • Subjects with systemic conditions such as type I and type I diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies/neoplasm and HIV infection will be excluded from the present investigation.
  • Subjects on drugs such as corticosteroids or antibiotics within 6 months of investigation or antiepileptic drugs (phenytoin or cyclosporine) having an impact on periodontal tissues will be excluded.
  • Pregnant women (pregnancy may alter the oral flora).
  • Current smokers and individuals who quit smoking less than 6 months.
  • Patients who have undergone periodontal therapy within the previous 6 months

研究组 & 干预措施

Healthy volunteers

Periodontitis patients without acute coronary syndrome

Acute coronary syndrome patients without periodontitis

Periodontitis and acute coronary syndrome patients

结局指标

主要结局

Changes in periodontal parameters

时间窗: Baseline-24 months

Change in periodontal probing depth (measured in mm higher value indicate disease progression)

Change in periodontal variables

时间窗: Baseline - 2 years

Change in Clinical attachment level (measured in mm higher value indicate disease progression)

Change in periodontal criteria

时间窗: Baseline - 2 years

Change in plaque index (measured as a ratio, range: 0 to 3, maximum value indicates worse outcome and minimum value indicates better outcome)

次要结局

未报告次要终点

研究者

发起方
Meenakshi Ammal Dental College and Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.Jaideep Mahendra

Head and Professor, Department of Periodontics

Meenakshi Ammal Dental College and Hospital

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