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临床试验/NCT03594968
NCT03594968已完成不适用

Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries

Recep Tayyip Erdogan University Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2018年4月15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
206
试验地点
1
主要终点
17-OH-progesterone

研究概览

简要总结

This study evaluates the oxidative stress parameters in females with polycystic ovary syndrome (PCOS) and clinically healthy. Because of the fact that both oral disease included periodontitis and dental caries, and metabolic syndrome are associated with systemic inflammation, these two disorders may be linked through a common pathophysiologic pathway

详细描述

Power analysis was performed with the G-Power software package to determine sample size. To cover possible data loss, 10% of a group were added to each group. Medical and dental examination will be performed both of control and experimental groups. Age and body mass index (BMI) will be recorded.

In dental examination decayed, missing, or filled teeth (DMFT) index will be used according to World Health Organization (WHO 1997) criteria. All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II). To analyze the correlation between oral health status and polycystic ovary syndrome linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.

研究设计

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

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • females with Polycystic Ovary Syndrome

排除标准

  • history of ovarian surgery, patients with thyroid or prolactin hormone level abnormalities, non-classic 21-hydroxylase deficiency and hormonal therapy, steroid drug use past 6 months, obese patients (body mass index, BMI > 35), acute or chronic upper respiratory tract diseases, dental fluorosis, patients using fluoride supplements or orthodontic appliances will not be included in the study.

结局指标

主要结局

17-OH-progesterone

时间窗: 1 day

17-OH-progesterone is tested by blood sample 20-100 ng/dL

luteinizing hormone

时间窗: 1 day

luteinizing hormone \[LH\] is tested by blood sample 1.68-15 U/L

FSH hormone ovarian morphology (PCOM)

时间窗: 1 Day

follicle-stimulating hormone \[FSH\] is tested by blood sample 6.3_24 mlu/ml

dehydroepiandrosterone-sulfate

时间窗: 1 day

dehydroepiandrosterone-sulfate \[DHEA-S\] is tested by blood sample 65 to 380 µg/dL or 1.75 to 10.26 µmol/L

次要结局

  • Clinical attachment level(1 Day)
  • Plaque Examination(1 Day)
  • dental examination(1 Day)
  • periodontal examination(1 Day)
  • Bleeding Examination(1 Day)
  • Gingival Examination(1 Day)

研究者

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

Gul Yildiz Telatar

Assistant Professor

Recep Tayyip Erdogan University Training and Research Hospital

研究点 (1)

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