Oral Therapeutic Education in Stimulated Parkinsonian Patients (BUCCO-PARK)

Rennes University Hospital

Status: Terminated

Conditions: Parkinson Disease; Oral Infection

Treatments: Behavioral: Oral education

Study type: Interventional

Funder types: Other

Identifiers

NCT03965390

35RC18_8971_BUCCO-PARK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Classical care pathway

No Intervention group

Description:

Patients are following classical care pathway. Before brain surgery patients will be included after oral, medical and life quality evaluation. After randomization in the control group, patients will be evaluated at 6 and 12months after surgery, during classical follow up visits.

Oral education

Experimental group

Description:

Patients are following classical care pathway but combined at each visit with an oral education Before brain surgery patients will be included after oral, medical and life quality evaluation. After randomization in the experimental group, patients will be evaluated at 6 and 12 months after surgery, during classical follow up visits. At each timepoint an oral education will be realized in parallel.

Treatment:

Behavioral: Oral education