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临床试验/NCT03190512
NCT03190512已完成不适用

The Effect of Periodontal Treatment on Depression, Body Image, Self-Esteem and Anxiety in Depressed Patients: A Randomized Controlled Clinical Trial

Ozge Gokturk2 个研究点 分布在 2 个国家目标入组 184 人开始时间: 2015年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
184
试验地点
2
主要终点
Depression level

研究概览

简要总结

There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease.

详细描述

Background: Depression is a multi-factorial disease characterized by a variety of symptoms. Psychiatric disorders seem to be more prone to periodontitis compared to patients without psychiatric disorders. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal disease can also be an effect on depression. The aim of this randomized controlled clinical study is to determine the effect of non-surgical mechanical periodontal treatment on psychological state.

Material and methods

The study population consisted of 184 depressed patients with non-treated periodontal diseases. Two randomized group is formed from these patients. Immediately periodontal treatment (test group, n = 92) and delayed periodontal treatment (control group, n = 92). Clinical periodontal and psychological measures were performed at baseline and 6th weeks on control and test group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • the presence of periodontal diseases,
  • the presence of diagnosed minor depression
  • being under maintenance therapy regarding the depression

排除标准

  • any hormonal condition such as pregnancy or lactation
  • received any periodontal treatment within six months

结局指标

主要结局

Depression level

时间窗: Baseline and after 6 weeks

The changes in depression level within 6 weeks. Depression level was determined using the Beck Depression Inventory.

次要结局

  • Body image level(Baseline and after 6 weeks)
  • Probing pocket depth(Baseline and after 6 weeks)
  • Gingival index(Baseline and after 6 weeks)
  • Plaque index(Baseline and after 6 weeks)
  • Bleeding on probing(Baseline and after 6 weeks)
  • Anxiety level(Baseline and after 6 weeks)
  • Self-esteem level(Baseline and after 6 weeks)
  • Clinical attachment level(Baseline and after 6 weeks)

研究者

发起方
Ozge Gokturk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ozge Gokturk

Principal Investigator

Tokat Gaziosmanpasa University

研究点 (2)

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