Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 12
- 主要终点
- Proportion of patients with a Community Peridontal Index (CPI) ≥3
研究概览
简要总结
There are few disease prevention programs or programs to manage somatic disorders in a psychiatric context. The aim of this study is to evaluate the impact in the medium term of a global program to promote dental health on buccodental hygiene in patients with schizophrenia and the ability of these patients to follow the intervention.
This is an interventional trial, randomized in clusters. The participating establishments will be randomized to the "intervention" group (promotion program) or the "control" group (surveillance).
For each patient, the study will last 12 months altogether and will include an initial evaluation of dental health, a 6-month education program for dental care (for patients in the "intervention" group) and a follow-up at 6 and 12 months after the start of the study. The follow-up will evaluate dental health and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM V)
- •Managed at a specialized establishment
- •Older than 18 years.
- •who have provided written informed consent to take part in the study
排除标准
- •Fully hospitalized patients
- •Patients who are unstable from a psychiatric poit of view or who suffer from delirium.
- •Subjects with less than one incisor, canine, premolar and molar on each hemi-arch
- •Patients with a risk of infectious endocarditis or a major risk of superinfection
- •Patients on long-term treatment with antibiotics (Impact of antibiotherapy on oral flora)
- •Patients treated with chemotherapy
- •Pregnant or breastfeeding women
- •Patients without National Health Insurance cover.
- •Poor written and/or oral comprehension of the French language
研究组 & 干预措施
Intervention
干预措施: Dental care education program (Other)
Surveillance
干预措施: Surveillance (Other)
结局指标
主要结局
Proportion of patients with a Community Peridontal Index (CPI) ≥3
时间窗: 6 months
次要结局
未报告次要终点