Exploratory Study of Oral Therapeutic Education in Stimulated Parkinsonian Patients: Monitoring of Periodontal Status and Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Parodontal disease progression after 12 months
研究概览
简要总结
The effect of periodontal disease on the general condition of patients remains today underestimated in Parkinson's disease. The BUCCO-PARK project aims to carry out an exploratory study of oral therapeutic education on the clinical evolution and fate of the microbiota of patients undergoing brain stimulation surgery. During the study, patients will follow the standard care pathway alone or combined with an oral therapeutic education. Biological samples will assess how the microbiota of these patients will be impacted. BUCCO-PARK aims to optimize the care of Parkinson's patients by integrating oral care.
详细描述
Patients included will be randomized in one of both defined groups : experimental group, in which patients will receive an oral education or control group, in which patient only follow the traditional care pathway.
Patients will be included in the trial before surgery after medical examination and life quality and oral environment evaluations.
Oral therapeutic education for patients randomized in experimental group will be performed at inclusion, and 6, and 12 months after surgery.
For all patients, an oral examination, an assessment of the quality of life and oral, fecal and blood samples will be carried out at inclusion, and 6 and 12 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 idiopathic Parkinson's disease for whom deep brain stimulation surgery (indifferent target) has been indicated for their Parkinson's disease
- •affiliated to a system of social security;
- •having at least 10 natural teeth (treated or not)
- •having received oral and written information on the protocol and having signed a consent to participate in this research.
排除标准
- •pregnant or lactating women;
- •Persons of legal age subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty;
- •Patients who do not speak French (both written and spoken);
- •Patients whose oral status is considered incompatible by the dental surgeon investigator with entry into the study (history of major maxillofacial surgery, presence of drugs that may cause gingival hypertrophy 2 or gingival bleeding 3).
结局指标
主要结局
Parodontal disease progression after 12 months
时间窗: 12 months
Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
次要结局
- Parodontal disease progression after 6 months(6 months)
- Parodontal disease progression at inclusion(1 month)
- Papillary bleeding index progression(12 months)
- NMSS score at inclusion(1 month)
- NMSS score after 12 months(12 months)
- beta diversity of microbiota(12 months)
- Change in non-motor aspects of experiences of daily living (MDS-UPDRS I)(12 months)
- Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II)(12 months)
- Change in motor examination during "on" periods (MDS-UPDRS III)(12 months)
- Motor symptom evaluation using Hoehn and Yahr score(12 months)
- Ferric markers determination(12 months)
- Plaque index progression(12 months)
- Caries index progression(12 months)
- NMSS score after 6 months(6 months)
- alpha diversity of microbiota(12 months)
- Gingival index progression(12 months)
- OHIP-14 score at inclusion(1 month)
- Change in motor complications with MDS-UPDRS IV(12 months)
- Number of loss of attachment(12 months)
- OHIP-14 score after 6 months(6 months)
- OHIP-14 score after 12 months(12 months)