Parkinson DiseaseBUCCO-PARKNCT03965390
Oral Therapeutic Education in Stimulated Parkinsonian Patients
A study testing Oral education in people with Parkinson Disease and Oral Infection, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Oral Infection
- What is being tested?
- Oral education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2019to 19 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of Oral Therapeutic Education in Stimulated Parkinsonian Patients: Monitoring of Periodontal Status and Microbiota
The effect of periodontal disease on the general condition of patients remains today underestimated in Parkinson's disease. The BUCCO-PARK project aims to carry out an exploratory study of oral therapeutic education on the clinical evolution and fate of the microbiota of patients undergoing brain stimulation surgery. During the study, patients will follow the standard care pathway alone or combined with an oral therapeutic education. Biological samples will assess how the microbiota of these patients will be impacted. BUCCO-PARK aims to optimize the care of Parkinson's patients by integrating oral care.
Read the 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.
- Conditions
- Parkinson Disease, Oral Infection
- Being tested
- Oral education
- Keywords
- oral microbiota, parkinson, brain stimulation surgery, oral therapeutic
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral educationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Classical care pathway | No intervention | 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. |
| Oral education | Experimental | 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. Receives: Behavioral: Oral education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parodontal disease progression after 12 months
Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
Measured: 12 months
Secondary outcomes (21)
Parodontal disease progression after 6 months
Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
Measured: 6 months
Parodontal disease progression at inclusion
Parodontal disease progression according to criteria defined by CDC/AAP at inclusion
Measured: 1 month
Caries index progression
Assessment of dental state using caries index (from 1 : low risk to 3) at inclusion and 6 and 12 months after surgery. Carious index measuring the number of decayed teeth, absent for decay and closed in permanent toothing.
Measured: 12 months
Plaque index progression
Assessment of dental state using plaque index (from 0 : absence of microbial plaque to 3 : large amount of plaque in sulcus or pocket), at inclusion and 6 and 12 months after surgery. After all teeth are examined and scored, the index is calculated by dividing the number of plaque containing surfaces by the total number of available surfaces.
Measured: 12 months
Gingival index progression
Assessment of dental state using gingival index at inclusion and 6, and 12 months after surgery. Gingivitis index is the number assigned to designate the degree of gingival inflammation. From 0 : Normal to 3 : Advanced gingivitis
Measured: 12 months
Papillary bleeding index progression
Assessment of dental state using papillary bleeding index at inclusion and 6, and 12 months after surgery. The intensity of any bleeding is recorded as: Score 0 - no bleeding; to Score 4 - Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
Measured: 12 months
Number of loss of attachment
Assessment of dental state using number of loss of attachment at inclusion and 6, and 12 months after surgery.
Measured: 12 months
OHIP-14 score at inclusion
oral health impacts profile (OHIP-14) score at inclusion. Questionnaire with 14 items, each from 1 (no problem) to 5 (Locker et al. J Can Dent Assoc, 1993)
Measured: 1 month
OHIP-14 score after 6 months
oral health impacts profile (OHIP-14) score 6 months after surgery. Questionnaire with 14 items, each from 1 (no problem) to 5 (Locker et al. J Can Dent Assoc, 1993)
Measured: 6 months
OHIP-14 score after 12 months
oral health impacts profile (OHIP-14) score 12 months after surgery. Questionnaire with 14 items, each from 1 (no problem) to 5 (Locker et al. J Can Dent Assoc, 1993)
Measured: 12 months
NMSS score at inclusion
Non Motor Symptoms Scale score at inclusion. Medical questionnaire with 30 items assessing symptoms progression. For each item, severity and frequency are assessed. Severity is assessed from 0 (no severity) to 3 and frequency from 1 (rare) to 4
Measured: 1 month
NMSS score after 6 months
Non Motor Symptoms Scale score 6 months after surgery. Medical questionnaire with 30 items assessing symptoms progression. For each item, severity and frequency are assessed. Severity is assessed from 0 (no severity) to 3 and frequency from 1 (rare) to 4
Measured: 6 months
NMSS score after 12 months
Non Motor Symptoms Scale score 12 months after surgery. Medical questionnaire with 30 items assessing symptoms progression. For each item, severity and frequency are assessed. Severity is assessed from 0 (no severity) to 3 and frequency from 1 (rare) to 4
Measured: 12 months
alpha diversity of microbiota
alpha diversity is expressed as number of observed species of oral and intestinal microbiota at inclusion, and 6, and 12 months after surgery. Alpha diversity is defined by Whittaker (1972) as the species richness of a place. The higher the number, the higher the diversity.
Measured: 12 months
beta diversity of microbiota
beta diversity is relative bacterial abundance at different levels in percent at inclusion, and 6, and 12 months after surgery. Beta diversity was defined by Whittaker (1972) as "the extent of species replacement or biotic change along environmental gradients. The higher the number, the higher the change is
Measured: 12 months
Change in non-motor aspects of experiences of daily living (MDS-UPDRS I)
Change in non-motor aspects of experiences of daily living (MDS-UPDRS I) between the Baseline assessment and the assessment at 6, and 12 months' follow up The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part I include 13 items (6 semistructured interview items and 7 self-reported items) scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.
Measured: 12 months
Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II)
Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II) between the Baseline assessment and the assessment at 6, and 12 months' follow up The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part II include 13 self-reported items) scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.
Measured: 12 months
Change in motor examination during "on" periods (MDS-UPDRS III)
Change in motor examination during "on" periods (MDS-UPDRS III) between the Baseline assessment and the assessment at 6, and 12 months' follow up The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part III include 18 items scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.
Measured: 12 months
Change in motor complications with MDS-UPDRS IV
Change in motor complications with MDS-UPDRS IV between the Baseline assessment and the assessment at 6, and 12 months' follow up The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part IV include 6 items assessed in a semistructured interview, scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.
Measured: 12 months
Motor symptom evaluation using Hoehn and Yahr score
Motor symptom evaluation using Hoehn and Yahr stade. Hoehn and Yahr score evaluation at inclusion and 6 and 12 months after surgery. Hoehn and Yahr ladder defines 6 stages, from 0 (no parkinson signs) to 6 (no more autonomy). Reference : Hoehn et al. Neurology 1967
Measured: 12 months
Ferric markers determination
Determination of ferric markers using ferric blood test results. Blood tests will be realized at inclusion and 6 and 12 months after surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start14 Dec 2019
- Primary completion19 May 2023
- Study completion19 May 2023
Why it stopped: impossibility of continuing the study due to lack of medical staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc VERIN, Pr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965390
- Sponsor's protocol ID
- 35RC18_8971_BUCCO-PARK
- Acronym
- BUCCO-PARK
- Status last verified
- Jun 2024
- First submitted
- 21 May 2019
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Oral Therapeutic Education in Stimulated Parkinsonian Patients: Monitoring of Periodontal Status and Microbiota
- ClinicalTrials.gov ID
- NCT03965390
- Acronym / sponsor ID
- BUCCO-PARK / 35RC18_8971_BUCCO-PARK
- Conditions
- Parkinson Disease, Oral Infection
- Keywords
- oral microbiota, parkinson, brain stimulation surgery, oral therapeutic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: impossibility of continuing the study due to lack of medical staff
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical care pathway | No intervention | –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. |
| Oral education | Experimental | Behavioral: Oral educationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral educationOral 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 | Behavioural | Oral education |
Primary outcome
Parodontal disease progression after 12 months
Time frame: 12 months
Parodontal disease progression according to criteria defined by CDC/AAP 6 months after surgery
21 secondary outcomes
Parodontal disease progression after 6 months
Time frame: 6 months
Parodontal disease progression at inclusion
Time frame: 1 month
Caries index progression
Time frame: 12 months
Plaque index progression
Time frame: 12 months
Gingival index progression
Time frame: 12 months
Papillary bleeding index progression
Time frame: 12 months
Number of loss of attachment
Time frame: 12 months
OHIP-14 score at inclusion
Time frame: 1 month
OHIP-14 score after 6 months
Time frame: 6 months
OHIP-14 score after 12 months
Time frame: 12 months
NMSS score at inclusion
Time frame: 1 month
NMSS score after 6 months
Time frame: 6 months
NMSS score after 12 months
Time frame: 12 months
alpha diversity of microbiota
Time frame: 12 months
beta diversity of microbiota
Time frame: 12 months
Change in non-motor aspects of experiences of daily living (MDS-UPDRS I)
Time frame: 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 examination during "on" periods (MDS-UPDRS III)
Time frame: 12 months
Change in motor complications with MDS-UPDRS IV
Time frame: 12 months
Motor symptom evaluation using Hoehn and Yahr score
Time frame: 12 months
Ferric markers determination
Time frame: 12 months
Results and safety
The study was stopped early (reason given: impossibility of continuing the study due to lack of medical staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc VERIN, Pr principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral education in people with Parkinson Disease and Oral Infection, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: impossibility of continuing the study due to lack of medical staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parodontal disease progression after 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.