- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03965390
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
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
-
-
-
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
Accepts Healthy Volunteers
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)
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. |
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
Time Frame: 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
Time Frame: 6 months
|
Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
|
6 months
|
Parodontal disease progression at inclusion
Time Frame: 1 month
|
Parodontal disease progression according to criteria defined by CDC/AAP at inclusion
|
1 month
|
Caries index progression
Time Frame: 12 months
|
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
Time Frame: 12 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 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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
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)
|
1 month
|
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)
|
6 months
|
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 months
|
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
|
1 month
|
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
|
6 months
|
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
|
12 months
|
alpha diversity of microbiota
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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)
Time Frame: 12 months
|
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)
Time Frame: 12 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, 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)
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Investigators
- Principal Investigator: Marc VERIN, Pr, Rennes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC18_8971_BUCCO-PARK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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