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临床试验/NCT01128374
NCT01128374已完成不适用

The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 DiabetesS

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2010年6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
134
试验地点
2
主要终点
HbA1c percentage

研究概览

简要总结

Type 2 diabetes mellitus (T2DM) has become a significant pandemic with more than 7% of the population in the United States affected. Moreover, up to one-third of these individuals may not be aware of the diagnosis and, are not involved in treatment. In the Mexican-American population, prevalence rates may be up to 50%. Contributing factors such as poor education, low household income, language barriers and restricted access to medical services may increase this prevalence. The association between periodontal disease and diabetes has been well documented; however, interventional studies have resulted in conflicting conclusions on improvements in glycemic control following periodontal therapy.

Diabetes and periodontal disease share common pathways in pathogenesis, such as their polygenic nature and immunoregulatory dysfunction. To answer these questions, we, the investigators, propose this randomized controlled trial designed to elucidate how treatment of periodontal disease can be used for preventive and therapeutic purposes in a diabetic population as well as to study the role of IL-1 gene cluster polymorphisms as a risk factor for the presence of periodontitis in a Hispanic T2DM population. Our central hypothesis is that the Mexican-American T2DM population in Texas is at risk for an increased presence and severity of periodontal disease due to the presence of Il-1 gene cluster polymorphisms; furthermore we suggest that providing non-surgical periodontal therapy to this group will decrease the bacterial load associated with disease and as a consequence, will improve glycemic control as measured by HbA1c values. Our long-term goal is to study risk factors associated with the presence of periodontal disease and to understand how the treatment of periodontal disease can be used for preventive and therapeutic purposes in a Hispanic type 2 diabetic population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • At least 18 years old
  • Diagnosed type 2 diabetes mellitus
  • Existence of moderate to severe periodontitis as defined by the American Academy of Periodontology
  • In good general health - able to undergo the proposed therapy without compromise to existing health
  • Demonstrated ability to read and understand written Spanish or English without the aid of ad-hoc interpretation by a third party
  • Demonstrated ability to understand the proposed therapy and possible outcome
  • Demonstrated willingness to comply with all protocol requirements as outlined in the informed consent document
  • Willingness/ability to sign an informed consent document for their own inclusion in the study
  • Hispanic origin as confirmed by patient records

排除标准

  • Pregnancy at the time of enrollment (Pregnancy test is required for female study participants of child-bearing potential.)
  • Use of antibiotics within last 3 months
  • Immunocompromised health status
  • Other medical conditions that represent a threat to life
  • Osteoporosis
  • Biphosphonates, corticosteroids or behavior alteration medications
  • Historical abuse of alcohol or drugs
  • Use of cigarettes/tobacco products within the past 12 months
  • Mental diseases
  • Any other oral pathology that compromise the patient's medical status
  • Diagnosed type 1 diabetes mellitus (Information will be obtained from the medical records)

结局指标

主要结局

HbA1c percentage

时间窗: At baseline and 120 days after treatment

次要结局

  • microbial burden(Baseline and 120 days after therapy)
  • gene polymorphisms(120 days after enrolment)

研究者

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

Isabel Gay

Assistant Professor - Periodontics, UT Houston Dental Branch

The University of Texas Health Science Center, Houston

研究点 (2)

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