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临床试验/NCT03786133
NCT03786133已完成不适用

The Subgingival Microbiota in Chronic Periodontitis Patients Affected by Type 2 Diabetes Mellitus: a Retrospective Comparative Study

University of Bologna1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年6月10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
40
试验地点
1
主要终点
Bacterial load of six main periodontal pathogens

研究概览

简要总结

This study is a retrospective comparative evaluation of six main periodontal pathogens and total bacterial load in chronic periodontitis patients affected or not by type 2 diabetes mellitus by polymerase chain reaction analysis.

详细描述

The aim of this study was to compare prevalence and bacterial load of six main periodontal pathogens among chronic periodontitis patients with and without type 2 diabetes mellitus. Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans genotypes were also investigated.

The recruitment for the study sample was performed analysing the medical records of adult patients with chronic periodontitis visited between 2010 and 2016. Eligible patients were subdivided in two balanced groups on the basis of the presence or absence of type 2 diabetes mellitus at the time of the microbiological test.

For each subject, the following data have been collected: age, gender, smoking habits, type of metabolic control of diabetes, duration of diabetes, number of missing teeth.

For each subject, four periodontal sites were studied. Probing pocket depth, sites with bleeding on probing, sites with suppuration and microbiological data were evaluated.

An individual matching on the basis of severity and extension of periodontitis was performed by pairing a diabetic patient with another non-diabetic one with the same degree of severity and extension of the periodontal disease.

研究设计

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

入排标准

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

入选标准

  • diagnosis of chronic periodontitis
  • diagnosis of type 2 diabetes mellitus (only in the test group)
  • the presence of at least 12 teeth (except for the third molar)
  • belonging to caucasian ethnic group
  • age greater than 18 years.

排除标准

  • pregnant or lactating
  • history of systemic antibiotics within 3 months prior to the microbiological testing or anti-inflammatory therapy in the month before the visit
  • if they were suffering from any other systemic disease except diabetes mellitus (arthritis, ulcerative colitis, Crohn's disease, osteoporosis or osteopenia, HIV infection, hematologic diseases, neoplastic diseases, cardiovascular diseases or pathologies that could potentially interfere with the periodontitis and/or with diabetes)
  • mental disorders
  • if they had received periodontal treatment in the 6 months before the microbiological test.

结局指标

主要结局

Bacterial load of six main periodontal pathogens

时间窗: November 16th 2016

Bacterial load mean of six main periodontal pathogens expressed as number after a polymerase chain reaction count

Prevalence of six main periodontal pathogens

时间窗: November 16th 2016

Number of sites presenting a specific pathogen

Total bacterial load

时间窗: November 16th 2016

A mean of all bacteria present in a periodontal site expressed as number after a polymerase chain reaction count

Relative bacterial load of six main periodontal pathogens

时间窗: November 16th 2016

A mean percentage that derives from the comparison of the bacterial load to the total bacterial load

次要结局

  • Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans(November 16th 2016)

研究者

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

Marco Montevecchi

Aggregate Professor of Periodontology

University of Bologna

研究点 (1)

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