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Periodontal Treatment and Psychology

2017年6月15日 更新者:Ozge Gokturk

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

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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

184

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tokat、火鸡、60250
        • Gaziosmanpasa University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器:Test Group

Psychological measurements were taken from periodontal disease patients before treatment and after 6 weeks.

Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and the Psychological questionnaires were filled.

Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
安慰剂比较:Control Group

Psychological measurements were taken from periodontal disease patients at the baseline and after 6 weeks without the periodontal treatment.

Intervention: The Psychological questionnaires were filled.

Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Depression level
大体时间:Baseline and after 6 weeks
The changes in depression level within 6 weeks. Depression level was determined using the Beck Depression Inventory.
Baseline and after 6 weeks

次要结果测量

结果测量
措施说明
大体时间
Body image level
大体时间:Baseline and after 6 weeks
The changes in body image level within 6 weeks. Body image level was determined using the Body Cathexis Scale.
Baseline and after 6 weeks
Anxiety level
大体时间:Baseline and after 6 weeks
The changes in anxiety level within 6 weeks. Anxiety level was determined using the Beck Anxiety Inventory.
Baseline and after 6 weeks
Self-esteem level
大体时间:Baseline and after 6 weeks
The changes in self-esteem level within 6 weeks. Self-esteem level was determined using the Rosenberg Self-Esteem Scale.
Baseline and after 6 weeks
Probing pocket depth
大体时间:Baseline and after 6 weeks
The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.
Baseline and after 6 weeks
Clinical attachment level
大体时间:Baseline and after 6 weeks
The changes in clinical attachment level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.
Baseline and after 6 weeks
Gingival index
大体时间:Baseline and after 6 weeks
The changes in gingival index level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.
Baseline and after 6 weeks
Plaque index
大体时间:Baseline and after 6 weeks
The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.
Baseline and after 6 weeks
Bleeding on probing
大体时间:Baseline and after 6 weeks
The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.
Baseline and after 6 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Ozge Gokturk、Gaziosmanpasa Universty

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年5月4日

初级完成 (实际的)

2016年3月31日

研究完成 (实际的)

2016年9月1日

研究注册日期

首次提交

2017年6月12日

首先提交符合 QC 标准的

2017年6月15日

首次发布 (实际的)

2017年6月16日

研究记录更新

最后更新发布 (实际的)

2017年6月16日

上次提交的符合 QC 标准的更新

2017年6月15日

最后验证

2017年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 14-KAEK-218

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Psychological measurements的临床试验

3
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