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临床试验/NCT07412795
NCT07412795尚未招募不适用

Effect of Non-Surgical Periodontal Therapy on Ischemia-Modified Albumin and Soluble ST2 in Patients With Stable Angina

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Change in serum ischemia-modified albumin (IMA) concentration after non-surgical periodontal therapy

研究概览

简要总结

The goal of this clinical study is to learn whether gum treatment can improve heart health. Researchers will compare blood markers related to heart disease before and after routine gum treatment.

The main questions this study aims to answer are:

Is gum disease a risk factor for heart disease? Can treating gum disease lower the risk of heart disease? Adults with stable angina (a type of heart disease) and adults without heart disease may take part in this study.

All participants will receive routine, non-surgical gum treatment, which is a standard dental care procedure. This includes professional cleaning to remove plaque and tartar from the teeth and practical education on tooth brushing and cleaning between the teeth. The treatment will be performed by a single researcher and completed in one visit within about one hour.

Participants will:

Provide a blood sample before gum treatment Receive routine, non-surgical gum treatment Return after three months for a follow-up visit Provide a second blood sample This study does not involve experimental drugs or devices. Participation is voluntary, and there is no cost to participants. The results may help researchers better understand how gum health is related to heart health.

详细描述

Periodontitis is a chronic, multifactorial inflammatory disease characterized by progressive destruction of the periodontal tissues and alveolar bone surrounding the teeth. It develops as a result of dysbiosis of the oral microbiota and an altered host immune response. Dental plaque is the primary etiological factor, and anaerobic periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola play a major role in disease progression.

Atherosclerotic cardiovascular disease and periodontitis are both major global health problems and share several common risk factors, including smoking, diabetes mellitus, obesity, poor oral hygiene, and chronic inflammation. Although establishing a direct causal relationship between the two conditions is challenging, increasing evidence suggests that periodontitis may contribute to endothelial dysfunction, atherosclerotic plaque instability, and an increased risk of cardiovascular events.

Two main biological mechanisms have been proposed to explain the association between periodontitis and cardiovascular disease. The first is a direct mechanism involving the translocation of periodontal pathogens into the bloodstream and their interaction with vascular endothelial cells. Periodontal bacteria and their components have been detected in atherosclerotic plaques, suggesting a potential role in plaque formation and progression. The second mechanism is indirect and involves systemic inflammation. Periodontitis induces a chronic inflammatory response characterized by elevated levels of proinflammatory cytokines and acute-phase proteins, which may promote atherosclerosis through endothelial dysfunction, altered lipid metabolism, and increased oxidative stress.

Stable angina pectoris is a clinical manifestation of coronary artery disease caused by reduced blood flow to the myocardium, typically due to atherosclerosis of the coronary arteries. It is characterized by predictable chest pain or discomfort that occurs during physical exertion or emotional stress and is relieved by rest or medication. Although stable angina is generally less acute than unstable angina, it remains a serious condition requiring appropriate management to reduce the risk of adverse cardiovascular outcomes.

Non-surgical periodontal therapy is the first-line treatment for periodontal disease and includes scaling and root planing to remove supragingival and subgingival plaque and calculus. This treatment aims to reduce the periodontal inflammatory burden, improve periodontal clinical parameters, and restore periodontal tissue health. Previous studies have shown that effective non-surgical periodontal therapy may also reduce systemic inflammatory markers and improve surrogate markers of early atherosclerosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Willingness to participate in the study and provide written informed consent
  • Age 18 years or older
  • No periodontal treatment within the past 6 months
  • No use of local or systemic antibiotics within the past 3 months

排除标准

  • Unwillingness to participate in the study or to provide informed consent
  • Age under 18 years
  • Use of local or systemic antibiotics for the treatment of widespread infection
  • within the past 3 months
  • Receipt of periodontal treatment within the past 6 months
  • Pregnancy or lactation (for female participants)
  • History of acute myocardial infarction within the past 6 months

研究组 & 干预措施

Stable angina and periodontitis group (SAP group)

Experimental

Individuals diagnosed with stable angina and periodontitis who will receive non-surgical

干预措施: Non-surgical periodontal therapy (scaling and root planing) (Procedure)

Periodontitis group (P group)

Experimental

Cardiovascularly healthy individuals diagnosed with periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing.

干预措施: Non-surgical periodontal therapy (scaling and root planing) (Procedure)

Control group (C group)

Active Comparator

Periodontally and cardiovascularly healthy individuals who will receive routine professional dental cleaning and standardized oral hygiene instruction.

干预措施: Non-surgical periodontal therapy (Professional dental cleaning) (Procedure)

结局指标

主要结局

Change in serum ischemia-modified albumin (IMA) concentration after non-surgical periodontal therapy

时间窗: Baseline and 3 months

Serum ischemia-modified albumin (IMA) concentration measured in nanograms per milliliter (ng/mL) using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. Assessed at baseline and 3 months after non-surgical periodontal therapy.

次要结局

  • Change in serum soluble suppression of tumorigenicity 2(sST2) concentration after non-surgical periodontal therapy(Baseline and 3 months)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sena Altintas

Research assistant

Ondokuz Mayıs University

研究点 (1)

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