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出境医 / 临床实验 / Oral Therapeutic Education in Stimulated Parkinsonian Patients (BUCCO-PARK)

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

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
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


Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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).
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Marie-Laure Gervais 0299284312 ext +33 marie-laure.gervais@chu-rennes.fr

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Marc VERIN, Pr Rennes University Hospital
Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE December 14, 2019
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
Parodontal disease progression after 2 years [ Time Frame: 2 years ]
Parodontal disease progression according to criteria defined by CDC/AAP 2 years after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Parodontal disease progression after 6 months [ Time Frame: 6 months ]
    Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
  • Parodontal disease progression after 12 months [ Time Frame: 12 months ]
    Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
  • Parodontal disease progression at inclusion [ Time Frame: 1 month ]
    Parodontal disease progression according to criteria defined by CDC/AAP at inclusion
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • Number of infections [ Time Frame: 24 months ]
    Number of infections developed during the study and caracteriztion of the infectious agent
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Parodontal disease progression after 6 months [ Time Frame: 6 months ]
    Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
  • Parodontal disease progression after 12 months [ Time Frame: 12 months ]
    Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
  • Parodontal disease progression at inclusion [ Time Frame: 1 month ]
    Parodontal disease progression according to criteria defined by CDC/AAP at inclusion
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • Number of infections [ Time Frame: 24 months ]
    Number of infections developed during the study and caracteriztion of the infectious agent
  • alpha diversity index of microbiota [ Time Frame: 24 months ]
    alpha diversity index 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 index, the higher the diversity
  • beta diversity index of microbiota [ Time Frame: 24 months ]
    beta diversity index of oral and intestinal microbiota 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 index, the higher the change is
  • Motor symptom evaluation using MDS-UPDRS score [ Time Frame: 24 months ]
    Motor symptom evaluation using MDS-UPDRS score. MDS-UPDRS score evaluation at inclusion and 6, 12 and 24 months after surgery. Unified Parkinson's Disease Rating Scale (UPDRS) sponsored by the Movement Disorder Society (MDS). Reference : Goetz et al. Movement disorders 2008. The higher the score is, the higher the disease symptoms are
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Therapeutic Education in Stimulated Parkinsonian Patients
Official Title  ICMJE Exploratory Study of Oral Therapeutic Education in Stimulated Parkinsonian Patients: Monitoring of Periodontal Status and Microbiota
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, 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Parkinson Disease
  • Oral Infection
Intervention  ICMJE 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

Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: Oral education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2024
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie-Laure Gervais 0299284312 ext +33 marie-laure.gervais@chu-rennes.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03965390
Other Study ID Numbers  ICMJE 35RC18_8971_BUCCO-PARK
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc VERIN, Pr Rennes University Hospital
PRS Account Rennes University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP