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临床试验/NCT04260880
NCT04260880已完成不适用

Assessment of Periodontal Status in Patients With Depression : A Cross Sectional Study.

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2020年1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
135
试验地点
1
主要终点
clinical attachment loss

研究概览

简要总结

To assess the periodontal status in the patients with depression. Evaluation of periodontal status in patients with mild depression. Evaluation of periodontal status in patients with moderate depression. Evaluation of periodontal parameters in patients without depression.

详细描述

Periodontitis, a periodontal disease, results from interaction between the immune system and oral bacteria that may promote oxidative stress and initiate an inflammatory cascade inducing the destruction of the oral structure.

The immune-microbial pathogenesis of periodontitis involves chronic inflammation, which alters the balance among multiple systems, including the neural, immune, and endocrine systems. Multiple systemic conditions, such as diabetes, cardiovascular diseases, and respiratory diseases, have been shown to have an inflammatory association with periodontitis, and pro-inflammatory cytokines such as tumor necrosis factor (TNF)-a, interleukin (IL)-1, and IL-6 are involved. In addition, distress experienced by the patients with periodontitis showed correlation with the progression of periodontitis. Studies have demonstrated that chronic stress and depression fall into a spectrum and could induce dysregulation of the immune system, impairing the course of periodontitis.

Depression, a disabling psychiatric disorder, manifests with depressed mood, vegetative symptoms, and cognitive impairment, and could impair the personal life quality and physical function. In 2015, this mental disorder was classified as the third main cause of global disability . It is a well established and important risk factor for many systemic conditions, including obesity, sleep disturbance, and chronic diseases . In addition to the general health conditions, oral diseases have also been associated with depression . Although some biomarkers were reported to be associated with depression, such as inflammatory cytokines, the serum level of neurotropic factors, and the hypothalamic-pituitary-adrenal (HPA) axis hormone, the clinical use are still unclear.

In the last years, most studies have drawn attention to a contribution of depression to poor oral health status . Conversely, there are researchers investigating a possible influence of oral health conditions on depression suggesting a bi-directional relationship between oral health and mental disorders. Therefore, it can be hypothesized that treatment of periodontitis may lead to improvement in the depression score in patients.

Only few cross-sectional studies have been conducted evaluating association of depression and periodontitis that too in high income countries (Finland, USA and Korea) and the results are inconclusive. So the present study will be conducted in our country to evaluate association of periodontitis and depression to provide high level of evidence.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with age 18-50 years
  • Newly diagnosed patients of clinical depression (international classification of diseases, classification of Mental and Behavioural Disorders, 10th Revision, Diagnostic criteria for Research35 )
  • Having ≥20 natural teeth
  • Exclusion criteria
  • Systemic disease or condition that is reported to be associated with periodontal disease, including diabetes mellitus, osteoporosis, rheumatoid arthritis, chronic renal failure, cardiovascular disease, and pregnancy
  • Treatment with the following drugs in the previous 3 months: antibiotics, anti-inflammatories, steroids, immune-suppressants, lipid-lowering drugs, anticoagulants, bisphosphonates, and host modulatory drugs
  • Psychiatric disorder other than depression or any other comorbid psychiatric disorder (organic mental disorder, disorders as a result of psychoactive substance use, schizophrenia and schizoaffective disorder, delirium, delusion, dementia, eating disorders, type 1 or 2 bipolar disorder, neurotic disorder, and psychotic depression)
  • Treatment with any antidepressant drug
  • Non-surgical or surgical periodontal treatment within the past 6 months before inclusion into the study

排除标准

  • 未提供

结局指标

主要结局

clinical attachment loss

时间窗: 1 year

It will be measured from cemento-enamel junction to base of the pocket.

次要结局

  • pocket depth(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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