Trials / Terminated
TerminatedNCT03965390
Oral Therapeutic Education in Stimulated Parkinsonian Patients
Exploratory Study of Oral Therapeutic Education in Stimulated Parkinsonian Patients: Monitoring of Periodontal Status and Microbiota
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Rennes University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Oral education | Oral therapeutic education aims to improve dietary practices, daily hygiene and care, in an approach adapted to the characteristics and consequences of Parkinson's disease. An oral prevention package will be given to patients. Initially, dentists expose various oral health problems commonly found in Parkinson's disease, in order to give patients the necessary information for the understanding Secondly, dentists dispenseront practical advice tailored to pathology, to maintain good oral health |
Timeline
- Start date
- 2019-12-14
- Primary completion
- 2023-05-19
- Completion
- 2023-05-19
- First posted
- 2019-05-29
- Last updated
- 2024-06-06
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03965390. Inclusion in this directory is not an endorsement.