Evaluation of Oral Hygiene Self-efficacy in Patients With Grief: a Short-term Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Frequency of dental plaque
研究概览
简要总结
to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and complicated grief (CG)
详细描述
Aim: to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and complicated grief (CG). Study design: randomized controlled trial. Setting: Institute of Psychiatry-FMUSP (Ipq-FMUSP). Subjects: cases: patients seeking for treatment or under treatment for CG (Group 1), and patients with normal grief (Group 2). Controls: Hospital staff at the HC-FMUSP or volunteers from a list of other studies conducted at the Ipq-FMUSP (Group 3). Method. Psychiatric evaluation: Structured Clinical Interview (SCID), Texas Revised Inventory of Grief (TRIG) and clinical interview. Intervention: instruction of oral hygiene. Dental evaluation: probing depth, clinical attachment level, bleeding on probing, and frequency of plaque at six sites per tooth. Procedures: all participants will complete the psychiatry and dental evaluation at baseline. The bleeding on probing and frequency of plaque will be recorded at baseline, once a week (1 month follow-up) and at 3 months. The probing depth and clinical attachment level will be recorded at baseline and at 3 months. After 3 months, the patients will be referred for dental 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of grief or complicated grief
- •Informed consent signature
排除标准
- •Patients with severe major depressive disorder at risk for suicide;
- •Substance abuse or dependence,
- •Psychotic disorders
- •Systemic alteration that precludes periodontal clinical examination
结局指标
主要结局
Frequency of dental plaque
时间窗: Change from baseline, 1 and 3 months after oral hygiene instruction
frequency of dental plaque at 6 sites per tooth
次要结局
- Bleeding on probing(Change from baseline, 1 and 3 months after oral hygiene instruction)
- probing depth(Change from baseline and 3 months after oral hygiene instruction)
- clinical attachment level(Change from baseline and 3 months after oral hygiene instruction)
研究者
Francisco Lotufo Neto
Principal investigator
University of Sao Paulo General Hospital