Comparing Inflammatory Markers in Patients With and Without Depression With Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Gingival crevicular fluid (GCF)
研究概览
简要总结
This study will evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease.
详细描述
The primary purpose of this study is to evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease. This study will also investigate the link between oral and systemic inflammation in patients diagnosed with depression and periodontal disease. Researcher will collect gingival crevicular fluid, plaque, tissue and blood serum samples to evaluate the link between these two diseases. The collection of gingival crevicular fluid, plaque and blood serum is relatively non-invasive, elicits minimal discomfort and does not require use of any anesthesia. The soft tissue sample will be collected as part of an otherwise planned periodontal surgical procedure under local anesthesia. In periodontal therapy (surgical procedures i.e. gum surgery, tooth extraction and or dental implant surgery) there is enough availability of remnant tissue for the collection of samples, which is otherwise discarded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old
- •Must be a patient of the UAB Dental School
- •Able to read and understand informed consent document
- •Good general health as evidenced by medical history
- •Minimum of 18 teeth, excluding third molars
- •Having moderate to severe periodontal disease according to AAP definition (teeth ≥5 mm PD and ≥3 mm CAL)
- •Having >30 percent bleeding sites upon probing
- •Patients taking depression medication with chronic periodontitis
- •Patients without depression with chronic periodontitis
- •Patients who have not had a dental cleaning in the past 3 months prior to procedure
- •Patients scheduled for surgical procedures (i.e. gum surgery, tooth extraction, or dental implants)
排除标准
- •Non-English speaking
- •Less than 18 years old
- •Smokers/tobacco users (>10 cigarettes/day)
- •Any dental condition that requires immediate treatment, such as emergency care
- •Chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti-inflammatory drugs, steroids). Low-dose aspirin (less than 325 mg daily)
- •Immunocompromised subjects
- •Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as uncontrolled diabetes, nifedipine, phenytoin (Dilantin), subjects with arthritis and morbidly obese (BMI ≥ 40)
结局指标
主要结局
Gingival crevicular fluid (GCF)
时间窗: baseline to 1 week
Measuring oral inflammatory markers in Gingival crevicular fluid (GCF) in patient with chronic periodontitis.
次要结局
- Plaque(baseline to 1 week)
研究者
Maninder Kaur
Principal Investigator
University of Alabama at Birmingham