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

Exploratory Study of Oral Therapeutic Education in Stimulated Parkinsonian Patients: Monitoring of Periodontal Status and Microbiota

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Oral Infection
• Intervention / Treatment: Behavioral: Oral education

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Laure Gervais; Phone Number: +33 0299284312; Email: marie-laure.gervais@chu-rennes.fr

Study Locations

• France
  • Besançon, France
    • Not yet recruiting
    • CHU Besançon
    • Contact: Mathieu BEREAU; Phone Number: +33 03 81 66 81 37
    • Principal Investigator: Mathieu BEREAU, Md
    • Sub-Investigator: Helene BIGEARD JOUFFROY, PhD
  • Rennes, France, 35033
    • Recruiting
    • CHU de Rennes
    • Contact: Manon Auffret; Phone Number: +33 299284312; Email: manon.auffret@univ-rennes1.fr
    • Contact: Marc Verin; Phone Number: +33 299284312; Email: marc.verin@chu-rennes.fr
    • Principal Investigator: Marc Verin, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parodontal disease progression after 12 months	Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parodontal disease progression after 6 months	Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery	6 months
Parodontal disease progression at inclusion	Parodontal disease progression according to criteria defined by CDC/AAP at inclusion	1 month
Caries index progression	Assessment of dental state using caries index (from 1 : low risk to 3) at inclusion and 6 and 12 months after surgery. Carious index measuring the number of decayed teeth, absent for decay and closed in permanent toothing.	12 months
Plaque index progression	Assessment of dental state using plaque index (from 0 : absence of microbial plaque to 3 : large amount of plaque in sulcus or pocket), at inclusion and 6 and 12 months after surgery. After all teeth are examined and scored, the index is calculated by dividing the number of plaque containing surfaces by the total number of available surfaces.	12 months
Gingival index progression	Assessment of dental state using gingival index at inclusion and 6, and 12 months after surgery. Gingivitis index is the number assigned to designate the degree of gingival inflammation. From 0 : Normal to 3 : Advanced gingivitis	12 months
Papillary bleeding index progression	Assessment of dental state using papillary bleeding index at inclusion and 6, and 12 months after surgery. The intensity of any bleeding is recorded as: Score 0 - no bleeding; to Score 4 - Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.	12 months
Number of loss of attachment	Assessment of dental state using number of loss of attachment at inclusion and 6, and 12 months after surgery.	12 months
OHIP-14 score at inclusion	oral health impacts profile (OHIP-14) score at inclusion. Questionnaire with 14 items, each from 1 (no problem) to 5 (Locker et al. J Can Dent Assoc, 1993)	1 month
OHIP-14 score after 6 months	oral health impacts profile (OHIP-14) score 6 months after surgery. Questionnaire with 14 items, each from 1 (no problem) to 5 (Locker et al. J Can Dent Assoc, 1993)	6 months
OHIP-14 score after 12 months	oral health impacts profile (OHIP-14) score 12 months after surgery. Questionnaire with 14 items, each from 1 (no problem) to 5 (Locker et al. J Can Dent Assoc, 1993)	12 months
NMSS score at inclusion	Non Motor Symptoms Scale score at inclusion. Medical questionnaire with 30 items assessing symptoms progression. For each item, severity and frequency are assessed. Severity is assessed from 0 (no severity) to 3 and frequency from 1 (rare) to 4	1 month
NMSS score after 6 months	Non Motor Symptoms Scale score 6 months after surgery. Medical questionnaire with 30 items assessing symptoms progression. For each item, severity and frequency are assessed. Severity is assessed from 0 (no severity) to 3 and frequency from 1 (rare) to 4	6 months
NMSS score after 12 months	Non Motor Symptoms Scale score 12 months after surgery. Medical questionnaire with 30 items assessing symptoms progression. For each item, severity and frequency are assessed. Severity is assessed from 0 (no severity) to 3 and frequency from 1 (rare) to 4	12 months
alpha diversity of microbiota	alpha diversity is expressed as number of observed species of oral and intestinal microbiota at inclusion, and 6, and 12 months after surgery. Alpha diversity is defined by Whittaker (1972) as the species richness of a place. The higher the number, the higher the diversity.	12 months
beta diversity of microbiota	beta diversity is relative bacterial abundance at different levels in percent at inclusion, and 6, and 12 months after surgery. Beta diversity was defined by Whittaker (1972) as "the extent of species replacement or biotic change along environmental gradients. The higher the number, the higher the change is	12 months
Change in non-motor aspects of experiences of daily living (MDS-UPDRS I)	Change in non-motor aspects of experiences of daily living (MDS-UPDRS I) between the Baseline assessment and the assessment at 6, and 12 months' follow up The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part I include 13 items (6 semistructured interview items and 7 self-reported items) scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.	12 months
Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II)	Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II) between the Baseline assessment and the assessment at 6, and 12 months' follow up The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part II include 13 self-reported items) scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.	12 months
Change in motor examination during "on" periods (MDS-UPDRS III)	Change in motor examination during "on" periods (MDS-UPDRS III) between the Baseline assessment and the assessment at 6, and 12 months' follow up The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part III include 18 items scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.	12 months
Change in motor complications with MDS-UPDRS IV	Change in motor complications with MDS-UPDRS IV between the Baseline assessment and the assessment at 6, and 12 months' follow up The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part IV include 6 items assessed in a semistructured interview, scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.	12 months
Motor symptom evaluation using Hoehn and Yahr score	Motor symptom evaluation using Hoehn and Yahr stade. Hoehn and Yahr score evaluation at inclusion and 6 and 12 months after surgery. Hoehn and Yahr ladder defines 6 stages, from 0 (no parkinson signs) to 6 (no more autonomy). Reference : Hoehn et al. Neurology 1967	12 months
Ferric markers determination	Determination of ferric markers using ferric blood test results. Blood tests will be realized at inclusion and 6 and 12 months after surgery	12 months

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Marc VERIN, Pr, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2019
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: parkinson; oral microbiota; brain stimulation surgery; oral therapeutic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 35RC18_8971_BUCCO-PARK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No