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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965390
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Oral Infection Behavioral: Oral education Not Applicable

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, 12 and 24 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, 12 and 24 months after surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exploratory Study of Oral Therapeutic Education in Stimulated Parkinsonian Patients: Monitoring of Periodontal Status and Microbiota
Actual Study Start Date : December 14, 2019
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


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, 12 and 24 months 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, 12 and 24 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





Primary Outcome Measures :
  1. Parodontal disease progression after 2 years [ Time Frame: 2 years ]
    Parodontal disease progression according to criteria defined by CDC/AAP 2 years after surgery


Secondary Outcome Measures :
  1. Parodontal disease progression after 6 months [ Time Frame: 6 months ]
    Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery

  2. Parodontal disease progression after 12 months [ Time Frame: 12 months ]
    Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery

  3. Parodontal disease progression at inclusion [ Time Frame: 1 month ]
    Parodontal disease progression according to criteria defined by CDC/AAP at inclusion

  4. Caries index progression [ Time Frame: 24 months ]
    Assessment of dental state using caries index (from 1 : low risk to 3) at inclusion and 6, 12 and 24 months after surgery. Carious index measuring the number of decayed teeth, absent for decay and closed in permanent toothing.

  5. Plaque index progression [ Time Frame: 24 months ]
    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, 12 and 24 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.

  6. Gingival index progression [ Time Frame: 24 months ]
    Assessment of dental state using gingival index at inclusion and 6, 12 and 24 months after surgery. Gingivitis index is the number assigned to designate the degree of gingival inflammation. From 0 : Normal to 3 : Advanced gingivitis

  7. Papillary bleeding index progression [ Time Frame: 24 months ]
    Assessment of dental state using papillary bleeding index at inclusion and 6, 12 and 24 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.

  8. Number of loss of attachment [ Time Frame: 24 months ]
    Assessment of dental state using number of loss of attachment at inclusion and 6, 12 and 24 months after surgery.

  9. OHIP-14 score at inclusion [ Time Frame: 1 month ]
    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)

  10. OHIP-14 score after 6 months [ Time Frame: 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)

  11. OHIP-14 score after 12 months [ Time Frame: 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. OHIP-14 score after 24 months [ Time Frame: 24 months ]
    oral health impacts profile (OHIP-14) score 24 months after surgery. Self-questionnaire with 14 items, each from 1 (no problem) to 5 (Locker et al. J Can Dent Assoc, 1993)

  13. NMSS score at inclusion [ Time Frame: 1 month ]
    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

  14. NMSS score after 6 months [ Time Frame: 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

  15. NMSS score after 12 months [ Time Frame: 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

  16. NMSS score after 24 months [ Time Frame: 24 months ]
    Non Motor Symptoms Scale score 24 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

  17. Number of infections [ Time Frame: 24 months ]
    Number of infections developed during the study and caracteriztion of the infectious agent

  18. alpha diversity of microbiota [ Time Frame: 24 months ]
    alpha diversity is expressed as number of observed species of oral and intestinal microbiota at inclusion, and 6, 12 and 24 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.

  19. beta diversity of microbiota [ Time Frame: 24 months ]
    beta diversity is relative bacterial abundance at different levels in percent at inclusion, and 6, 12 and 24 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

  20. Change in non-motor aspects of experiences of daily living (MDS-UPDRS I) [ Time Frame: 24 months ]
    Change in non-motor aspects of experiences of daily living (MDS-UPDRS I) between the Baseline assessment and the assessment at 6, 12 & 24 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.

  21. Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II) [ Time Frame: 24 months ]
    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, 12 & 24 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.

  22. Change in motor examination during "on" periods (MDS-UPDRS III) [ Time Frame: 24 months ]
    Change in motor examination during "on" periods (MDS-UPDRS III) between the Baseline assessment and the assessment at 6, 12 & 24 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.

  23. Change in motor complications with MDS-UPDRS IV [ Time Frame: 24 months ]
    Change in motor complications with MDS-UPDRS IV between the Baseline assessment and the assessment at 6, 12 & 24 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.

  24. Motor symptom evaluation using Hoehn and Yahr score [ Time Frame: 24 months ]
    Motor symptom evaluation using Hoehn and Yahr stade. Hoehn and Yahr score evaluation at inclusion and 6, 12 and 24 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

  25. Ferric markers determination [ Time Frame: 24 months ]
    Determination of ferric markers using ferric blood test results. Blood tests will be realized at inclusion and 6, 12 and 24 months after surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965390


Contacts
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Contact: Marie-Laure Gervais 0299284312 ext +33 marie-laure.gervais@chu-rennes.fr

Locations
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France
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Manon Auffret    299284312 ext +33    manon.auffret@univ-rennes1.fr   
Contact: Marc Verin    299284312 ext +33    marc.verin@chu-rennes.fr   
Principal Investigator: Marc Verin, Pr         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Marc VERIN, Pr Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03965390    
Other Study ID Numbers: 35RC18_8971_BUCCO-PARK
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
oral microbiota
parkinson
brain stimulation surgery
oral therapeutic
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases