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临床试验/NCT03241277
NCT03241277Unknown不适用

Evaluation of Nonsurgical Periodontal Treatment in Patients With Social Phobia: a Randomized Controlled Clinical Trial

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年10月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
试验地点
2
主要终点
Probing depth

研究概览

简要总结

Objective: To investigate the impact of nonsurgical periodontal treatment in patients with social anxiety disorder (SAD) and controls without phobia.

详细描述

Study design: randomized controlled trial. Setting: Institute of Psychiatry from FMUSP (Ipq-FMUSP). Subjects: patients seeking for Social Phobia treatment at IPq-FMUSP ( before and under treatment). Controls: Hospital staff at the HC-FMUSP or volunteers from a list of other studies conducted at the Ipq-FMUSP. Methods: Dental evaluation: probing depth, clinical attachment level and bleeding on probing will be recorded at 6 sites per tooth, as well as the plaque and/or calculus indexes. The number of decayed, missing and filled teeth (DMFT index) will be also assessed. The visual analogue scale (VAS) will be applied for the assessment of pain after probing after the probing recording. Patients will receive a clinical evaluation for halitosis using a Halimeter® to verify the concentration of the volatile sulfur compounds (before and after periodontal treatment). Main psychiatric assessment: Structured Clinical Interview (SCID) for DSM-IV-TR adapted for DSM-5, the Liebowitz Social Anxiety (LSAs). Duration and frequency: after the initial clinical assessment (dental and psychiatric) patients will be randomized into three groups. Two groups (experimental- social phobia with no psychiatric treatment and control) will receive periodontal treatment after the initial psychiatric evaluation. One group will receive periodontal treatment after the improvement of psychiatric condition (3 months after the initial assessment). The non-surgical periodontal treatment will be performed preferably within 24 h. Patients will be reevaluated 3 and 6 months after the end of nonsurgical periodontal treatment.

研究设计

研究类型
Interventional
分配方式
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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Social Phobia according to the DSM-IV TR adapted for the DSM-5
  • Patients with cut-off score of 4 (moderately ill) in the Global Clinical Impression (GCI) rating scale
  • Informed consent signature

排除标准

  • Patients with severe major depressive disorder at risk for suicide; substance abuse or dependence, psychotic disorders or psychotherapy treatment
  • Patients in psychotherapy treatment
  • Systemic alteration that precludes periodontal clinical examination

结局指标

主要结局

Probing depth

时间窗: Change from baseline at 6 months

the distance from the clinical gingival margin to probe tip

次要结局

  • Clinical attachment level(Change from baseline at 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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