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临床试验/NCT02671136
NCT02671136终止不适用

Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes

Loma Linda University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2016年8月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Counts of Each Subgingival Bacterial Species

研究概览

简要总结

Diabetes and Periodontitis are both prevalent diseases affecting millions of Americans. Periodontitis is prevalent among Diabetics. Furthermore, Periodontitis and associated inflammation can increase insulin resistance in Diabetics and worsens the condition. Hyperbaric Oxygen Therapy (HBOT) has the potential to improve periodontal treatment outcome in poorly controlled diabetics. The study will compare periodontal treatment (SRP) outcome between 2 main diabetic type 2 patient groups receiving medical care treatment: either Conventional Wound Therapies (CWC) with or without adjunctive Hyperbaric Oxygen Therapy at LLU Health.

24 poorly controlled diabetic mellitus (DM) type 2 subjects (HbA1c =>7%) with Periodontitis will be assigned into the study arms HBO therapy and Non HBO therapy, based on their medical needs.

For all subjects demographic data (age, gender, ethnicity, smoking history, alcohol use history, BMI, current medication list) and oral health habits will be obtained. Blood samples for HbA1c determinations, clinical periodontal measurements (plaque index, probing measurements including pocket depth, attachment levels, gingival index and bleeding-on-probing) and subgingival microbial samples will be obtained at baseline and end of the study. Subgingival microbial samples will be collected from three randomly selected sites and analyzed for detection of about 300 of the most prevalent oral bacterial species. Differences in periodontal clinical outcomes and bacterial profiles will be identified utilizing ANCOVA (Analysis of Covariance).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetes type 2 (HbA1c =>7%)
  • Generalized moderate to severe chronic periodontitis.
  • Minimum of 10 permanent teeth
  • Registered LLU patients

排除标准

  • Well controlled Diabetes type 2
  • Other systematic conditions with known associations to periodontitis
  • Intra-oral conditions which may interfere with the accuracy of periodontal probing
  • BMI greater than 45%

研究组 & 干预措施

CWC with HBO

Other

Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy

干预措施: Hyperbaric Oxygen therapy (Device)

CWC with HBO

Other

Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy

干预措施: Conventional Wound Therapies (Other)

CWC without HBO

Other

Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy

干预措施: Conventional Wound Therapies (Other)

结局指标

主要结局

Counts of Each Subgingival Bacterial Species

时间窗: 12 weeks

Subgingival microbial samples will be obtained at baseline and end of the study. Subgingival microbial samples will be collected from three randomly selected sites with probing depth =\>5mm. Collected microbial samples will be processed for HOMINGS analysis (The Human Oral Microbe Identification Microarray). Counts and proportions of each bacterial species will be determined for each subject and then averaged across subjects in the two groups. Differences in bacterial profiles will be analyzed using the repeated measures ANCOVA (Analysis of Covariance) procedure for paired observations.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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