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临床试验/NCT06638580
NCT06638580已完成不适用

Periodontitis Provokes Retinal Neurodegenerative Effects of Metabolic Syndrome: A Cross-Sectional Study

Recep Tayyip Erdogan University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
optical coherence tomography (OCT)

研究概览

简要总结

This cross-sectional study aimed to investigate the retino-choroidal degenerative effects of periodontitis, metabolic syndrome (Mets), and the combination of these diseases using optical coherence tomography (OCT) measurements. Methods: Ninety-two patients selected according to inclusion criteria were divided into 4 groups: systemically and periodontally healthy (Control), systemically healthy periodontitis (PD), periodontally healthy metabolic syndrome (MetS), and periodontitis and metabolic syndrome combined (PD-MetS). The systemic inflammatory-oxidative effects of periodontitis and MetS were biochemically evaluated using serum TNF (Tumor necrosis factor)-α level, IL(Interleukin)-1β/IL-10 ratio, and oxidative stress index (OSI: TOS/TAS). Retinal (AMT, peripapillary retinal nerve fiber layer thickness (pRNFLT), and Ganglion cell and Inner plexiform layers (GCL+T) and choroidal (SFCT) morphometric measurements and vascular evaluations (foveal capillary density) were performed via OCT Angio with swept-source technology.

To the best of our knowledge, although there are many clinical studies on the possible effects of Mets on retino-choroidal layers, there is a limited amount of evidence on the effects of periodontitis which is from an animal study. Moreover, there are no studies on the retinal degenerative effects of the combined presence of periodontitis and Mets. In this context, the present study is unique and based on the hypothesis that the alone or combined presence of periodontitis and Mets may provoke retino-choroidal degenerative changes through systemic inflammatory stress.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

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

  • Individuals with stage III/IV, grade C periodontitis,
  • Patients with at least 20 teeth,
  • Patients diagnosed with MetS,
  • Obese [waist circumference (WC) 80 cm ≥ for women and 94 cm ≥ for men], Type 2 (Diabetes Mellitus) DM and hypertensive patients.

排除标准

  • Any autoimmune disease,
  • Osteoporosis,
  • Active infectious disease (acute hepatitis, tuberculosis, AIDS),
  • Vitreoretinal, optic nerve or choroidal vascular disease,
  • Acute and chronic ocular diseases (such as cataract, glaucoma, macular degeneration, uveitis, Behçet's, scleritis),
  • History of refractive or intraocular surgery,
  • Immunosuppressive, oral contraceptive, bisphosphonate and antioxidant drug use,
  • Pregnancylactation,

结局指标

主要结局

optical coherence tomography (OCT)

时间窗: 6 months

Retinal and choroidal imaging and measurements will perform with it.

次要结局

  • probing pocket depth (PPD)(6 months)
  • clinical attachment level (CAL)(6 months)

研究者

发起方
Recep Tayyip Erdogan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Yemenoglu

Assistant Professor

Recep Tayyip Erdogan University

研究点 (1)

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