Clinical trial NCT03965390: Oral Therapeutic Education in Stimulated Parkinsonian Patients
Official title: Exploratory Study of Oral Therapeutic Education in Stimulated Parkinsonian Patients: Monitoring of Periodontal Status and Microbiota
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Oral Infection
Keywords: oral microbiota
parkinson
brain stimulation surgery
oral therapeutic
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Parodontal disease progression after 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Parodontal disease progression after 6 months
timeFrame: 6 months
measure: Parodontal disease progression at inclusion
timeFrame: 1 month
measure: Caries index progression
timeFrame: 12 months
measure: Plaque index progression
timeFrame: 12 months
measure: Gingival index progression
timeFrame: 12 months
measure: Papillary bleeding index progression
timeFrame: 12 months
measure: Number of loss of attachment
timeFrame: 12 months
measure: OHIP-14 score at inclusion
timeFrame: 1 month
measure: OHIP-14 score after 6 months
timeFrame: 6 months
measure: OHIP-14 score after 12 months
timeFrame: 12 months
measure: NMSS score at inclusion
timeFrame: 1 month
measure: NMSS score after 6 months
timeFrame: 6 months
measure: NMSS score after 12 months
timeFrame: 12 months
measure: alpha diversity of microbiota
timeFrame: 12 months
measure: beta diversity of microbiota
timeFrame: 12 months
measure: Change in non-motor aspects of experiences of daily living (MDS-UPDRS I)
timeFrame: 12 months
measure: Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II)
timeFrame: 12 months
measure: Change in motor examination during "on" periods (MDS-UPDRS III)
timeFrame: 12 months
measure: Change in motor complications with MDS-UPDRS IV
timeFrame: 12 months
measure: Motor symptom evaluation using Hoehn and Yahr score
timeFrame: 12 months
measure: Ferric markers determination
timeFrame: 12 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Marc VERIN, Pr
role: PRINCIPAL_INVESTIGATOR
References: