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临床试验/NCT02903264
NCT02903264已完成不适用

Gestational Diabetes Mellitus, Obesity and Periodontal Disease: a Cross Sectional Study

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
1
主要终点
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity

研究概览

简要总结

This study evaluated the periodontal condition of gestational diabetes mellitus (GDM) patients and a healthy non-pregnant control group. For the GDM group all medical data were recorded, including obesity/insulin resistance indicators.

详细描述

Gestational diabetes mellitus is associated to a worse periodontal condition. Many patients with these two diseases are also obese. After delivery, some patients maintain the pre-pregnancy obesity status and this condition is also associated to periodontal disease. The mechanisms involved in the relationship of all these medical and periodontal conditions are not clear.

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 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion criteria for GDM group was pregnant women with diagnosis of GDM based on glucose determination described in a previous study (19) and under medical treatment of an endocrinologist and the presence of at least one tooth per sextant.
  • Inclusion criteria for control group were absence of periodontal disease, mean age similar to test group and presence of at least one tooth per sextant.

排除标准

  • The exclusion criteria for GDM group were pregnant women without diagnosis of diabetes, age below 18 years or higher than 42 years, and the presence of other systemic diseases.
  • In control group, women were excluded if they were pregnant, had diabetes or other systemic disease and age below 18 years or higher than 42 years.

结局指标

主要结局

Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity

时间窗: One day

Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 6mm and ≥1 interproximal site with PPD ≥5mm. Moderate periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 4mm or ≥ 2 interproximal sites in different teeth with PPD ≥5mm. Mild periodontitis was defined as ≥ 2 interproximal sites in different teeth with ≥ 3 mm CAL and ≥ 2 interproximal sites in different teeth with ≥ 4 mm PPD or at least 1 site with PPD ≥ 5 mm (20,21). Gingivitis was determined as follows: Subjects were considered healthy if presented PPD ≤3mm/BOP extent scores \< 10% and with gingivitis if presented PPD ≤3mm/ BOP extent scores \>10%. Prevalence of periodontal disease was the sum of gingivitis, mild, moderate and severe periodontitis.

Obesity measured by a tape and a scale

时间窗: one day

Obese if: body mass index - BMI ≥ 25 Kg/m2 (weight in kilograms, height in meters) Obese if : waist-to-hip ratio - WHR \>0.85 (cm)

Gestational diabetes mellitus diagnosed by an endocrinologist

时间窗: one day

Diagnosis stablished by a doctor based on glucose determination. The data was registered in the patient's medical chart.

次要结局

  • Dyslipidemia as an indicator of obesity/insulin resistance(one day)
  • Leukocytosis as an indicator of inflammation(one day)

研究者

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

Carla Andreotti Damante

Associate professor

University of Sao Paulo

研究点 (1)

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