Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes
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
- 否
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
Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy
干预措施: Hyperbaric Oxygen therapy (Device)
CWC with HBO
Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy
干预措施: Conventional Wound Therapies (Other)
CWC without HBO
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
