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