Oral Therapeutic Education in Stimulated Parkinsonian Patients

NCT03965390 | Terminated

• 1 other identifier: 35RC18_8971_BUCCO-PARK
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Oral Infection

Keywords

oral microbiota; parkinson; brain stimulation surgery; oral therapeutic

Outcome Measures

Primary Outcomes (1)

• Parodontal disease progression after 12 months

  Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery

  12 months

Secondary Outcomes (21)

• Parodontal disease progression after 6 months

  6 months

• Parodontal disease progression at inclusion

  1 month

• Caries index progression

  12 months

• Plaque index progression

  12 months

• Gingival index progression

  12 months

Study Arms (2)

Classical care pathway

NO INTERVENTION

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

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.

Behavioral: Oral education

Interventions

Oral education 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

Oral education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Marc VERIN, Pr

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 29, 2019
• Study Start: December 14, 2019
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

FR (1)