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

Primary Purpose

Parkinson Disease, Oral Infection

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oral education
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson Disease focused on measuring oral microbiota, parkinson, brain stimulation surgery, oral therapeutic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CHU de RennesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Classical care pathway

Oral education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Parodontal disease progression after 12 months
Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery

Secondary Outcome Measures

Parodontal disease progression after 6 months
Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
Parodontal disease progression at inclusion
Parodontal disease progression according to criteria defined by CDC/AAP at inclusion
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.
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.
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
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.
Number of loss of attachment
Assessment of dental state using number of loss of attachment at inclusion and 6, and 12 months after surgery.
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)
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)
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)
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
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
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
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.
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
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.
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.
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.
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.
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
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

Full Information

First Posted
May 21, 2019
Last Updated
March 28, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03965390
Brief Title
Oral Therapeutic Education in Stimulated Parkinsonian Patients
Acronym
BUCCO-PARK
Official Title
Exploratory Study of Oral Therapeutic Education in Stimulated Parkinsonian Patients: Monitoring of Periodontal Status and Microbiota
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2019 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Oral Infection
Keywords
oral microbiota, parkinson, brain stimulation surgery, oral therapeutic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Classical care pathway
Arm Type
No Intervention
Arm Description
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.
Arm Title
Oral education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Oral education
Intervention Description
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 Measure Information:
Title
Parodontal disease progression after 12 months
Description
Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Parodontal disease progression after 6 months
Description
Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
Time Frame
6 months
Title
Parodontal disease progression at inclusion
Description
Parodontal disease progression according to criteria defined by CDC/AAP at inclusion
Time Frame
1 month
Title
Caries index progression
Description
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.
Time Frame
12 months
Title
Plaque index progression
Description
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.
Time Frame
12 months
Title
Gingival index progression
Description
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
Time Frame
12 months
Title
Papillary bleeding index progression
Description
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.
Time Frame
12 months
Title
Number of loss of attachment
Description
Assessment of dental state using number of loss of attachment at inclusion and 6, and 12 months after surgery.
Time Frame
12 months
Title
OHIP-14 score at inclusion
Description
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)
Time Frame
1 month
Title
OHIP-14 score after 6 months
Description
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)
Time Frame
6 months
Title
OHIP-14 score after 12 months
Description
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)
Time Frame
12 months
Title
NMSS score at inclusion
Description
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
Time Frame
1 month
Title
NMSS score after 6 months
Description
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
Time Frame
6 months
Title
NMSS score after 12 months
Description
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
Time Frame
12 months
Title
alpha diversity of microbiota
Description
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.
Time Frame
12 months
Title
beta diversity of microbiota
Description
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
Time Frame
12 months
Title
Change in non-motor aspects of experiences of daily living (MDS-UPDRS I)
Description
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.
Time Frame
12 months
Title
Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II)
Description
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.
Time Frame
12 months
Title
Change in motor examination during "on" periods (MDS-UPDRS III)
Description
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.
Time Frame
12 months
Title
Change in motor complications with MDS-UPDRS IV
Description
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.
Time Frame
12 months
Title
Motor symptom evaluation using Hoehn and Yahr score
Description
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
Time Frame
12 months
Title
Ferric markers determination
Description
Determination of ferric markers using ferric blood test results. Blood tests will be realized at inclusion and 6 and 12 months after surgery
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Laure Gervais
Phone
0299284312
Ext
+33
Email
marie-laure.gervais@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc VERIN, Pr
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon Auffret
Phone
299284312
Ext
+33
Email
manon.auffret@univ-rennes1.fr
First Name & Middle Initial & Last Name & Degree
Marc Verin
Phone
299284312
Ext
+33
Email
marc.verin@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Marc Verin, Pr

12. IPD Sharing Statement

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Oral Therapeutic Education in Stimulated Parkinsonian Patients

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