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临床试验/NCT05513118
NCT05513118已完成不适用

Evaluation of the Relationship Between Menopause and Periodontal Health With Biochemical and Microbiological Parameters

Ege University1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
1
主要终点
Periodontitis

研究概览

简要总结

Menopause is characterized by major physiological and concomitant psychological changes. The study aimed to evaluate the association between oral health parameters, bone mineral density (BMD) and physiological or psychological symptoms in post-menopausal women (PMW), compared with regularly menstruating women (RMW). Inflammatory biomarker levels in gingival crevicular fluid, saliva, serum and determination of microbial niches in subgingival plaque samples were further aimed. The participants were asked to complete the Women's Health Questionnaire to measure emotional and physical well-being.

A total of 148 women (PMW, n=76,RMW, n=72) received a comprehensive medical assessment and a full-mouth oral examination. The corresponding bone mineral density (BMD) and body mass indices (BMI) were obtained from their medical records.

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
35 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being 35-65 years of age
  • Having history of spontaneous amenorrhea for the last 12 months for PMW.
  • Lack of irregularity in menstrual cycles during the past 12 months for RMPW.
  • Possessing at least 10 natural teeth without any prosthetic restoration

排除标准

  • History of antibiotics use in last 3 months
  • Ongoing cancer therapy
  • Presence of oral ulcers or acute infectious disease
  • Presence of diabetes mellitus

结局指标

主要结局

Periodontitis

时间窗: 1 month

Interdental attachment loss is detectable at ≥2 non-adjacent teeth, or buccal/oral attachment loss ≥3 mm with pocketing \>3 mm at ≥2 adjacent teeth were present.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülnur Emingil

Prof. Dr.

Ege University

研究点 (1)

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