Oral Therapeutic Education in Stimulated Parkinsonian Patients

NCT ID: NCT03965390

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-14
• Study Completion Date: 2023-05-19

Brief 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

Parkinson Disease; Oral Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Classical care pathway

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Oral education

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.

Group Type: EXPERIMENTAL

Oral education

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc VERIN, Pr

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

CHU de Rennes

Rennes, , France

Countries

France

Other Identifiers

35RC18_8971_BUCCO-PARK

Identifier Type: -

Identifier Source: org_study_id