Oral HealthPARKIDENTNCT03827551
Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients
A study testing Delivery of oral hygiene advices in people with Oral Health and Parkinson Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
This is a prospective interventional clinical study whose main objective is to determine the impact of oral hygiene guidance on the oral health status of patients with Parkinson disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Health, Parkinson Disease
- What is being tested?
- Delivery of oral hygiene advices
- 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
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2019to 6 Apr 2021
- 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
- Major patient
- Patient with Parkinson disease
- Able to give written informed consent
- Affiliated to French health care system
Who cannot join
- Patient under tutorship and curatorship
- Pregnant women
- Patient wearing subtotal or total dental prosthesis
- Antibiotic treatment or antiseptic mouthwashes in the month prior to sampling
- Patient with less than 6 teeth distributed on maxilla and mandible
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective interventional clinical study whose main objective is to determine the impact of oral hygiene guidance on the oral health status of patients with Parkinson disease
Read the detailed description
Caries and periodontitis are infectious diseases that can eventually lead to the loss of the dental organ. The masticatory deficit engendered will have repercussions on the general state of the subject and on his quality of life (pains, difficulties of feeding which can cause nutritional deficiencies ...). The systematic review of the literature, despite low levels of evidence, shows that there is an influence of Parkinson's disease on oral health. Our goal is therefore to determine the impact of implementing appropriate oral hygiene measures on improving the quality of life of patients with Parkinson's disease.
This is a 40-patient, interventional, preliminary study that will rely on indicators of oral health status (DMF, Periodontal Index, presence of pathogenic bacteria), as well as a questionnaire measuring impact of oral conditions on patient well-being (OHIP-14). These data will be collected before and after the implementation of the hygiene measures, within a period of 6 months.
- Conditions
- Oral Health, Parkinson Disease
- Being tested
- Delivery of oral hygiene advices
- Keywords
- Oral Health, Parkinson Disease, Tooth cavities, Saliva, Mucosa
- Medical subject headings
- Parkinson Disease, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery of oral hygiene advicesBehavioural
Patients will benefit from hygiene advice and maintenance of good oral health. No treatment will be administered as part of this study. Patients will continue their usual treatment according to the contraindications. Patients will benefit from salivary sampling and a collection of oral bacteria contained in the dental plaque using paper tips. These reviews will be conducted during the Inclusion Visit and the 6 month Follow-Up Visit.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Patients | Experimental | Not described Receives: Behavioral: Delivery of oral hygiene advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decayed Missing Filled (DMF) index score
Min value : 0 (good oral health), Max value : 32
Measured: 6 months after inclusion
Presence of cariogenic bacteria in saliva and dental film
Streptococcus mutans and Lactobacillus
Measured: 6 months after inclusion
Presence of periodontopathogenic bacteria in saliva and dental film
Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus
Measured: 6 months after inclusion
Secondary outcomes (8)
Decayed Missing Filled (DMF) index score
Min value : 0 (good oral health), Max value : 32
Measured: Inclusion visit (Day 0)
Presence of cariogenic bacteria in saliva and dental film
Streptococcus mutans and Lactobacillus
Measured: Inclusion visit (Day 0)
Presence of periodontopathogenic bacteria in saliva and dental film
Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus
Measured: Inclusion visit (Day 0)
Change of Oral Health Impact Profile-14 (OHIP-14)
Min value : 14, Max value : 70 (satisfactory oral health)
Measured: Inclusion Visit (Day 0) and 6 month after
Change of Geriatric/General Oral Health Assessment Index (GOHAI)
Min value : 12, Max value : 60 (satisfactory oral health)
Measured: Inclusion Visit (Day 0) and 6 month after
Saliva pH
Normal / Acid / Very acid
Measured: Inclusion Visit (Day 0) and 6 month after
Quantification of saliva flow
Normal / Low
Measured: Inclusion Visit (Day 0) and 6 month after
Change of Community Periodontal Index of Treatment Needs (CPITN)
CPI Min value : 0 (healthy periodontium), Max value : 4 ; TN Min value : 0 (No periodontal treatment needed), Max value : 3
Measured: Inclusion Visit (Day 0) and 6 month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start29 Apr 2019
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Capionis, France Parkinson Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827551
- Sponsor's protocol ID
- CHUBX 2018/44
- Acronym
- PARKIDENT
- Status last verified
- Sep 2021
- First submitted
- 25 Jan 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Samot J, Courtin E, Guehl D, Damon-Perriere N, Branchard O, Saint-Jean M, Chuy V, Ella B, Badet MC. Periodontal health in a longitudinal French cohort of people with Parkinson's disease. Sci Rep. 2026 Jun 5. doi: 10.1038/s41598-026-55641-3. Online ahead of print.
PubMed 42249009Donnet L, Claisse O, Samot J. Serotype and distribution of adhesion genes in Streptococcus mutans isolated from people with Parkinson's disease. Odontology. 2025 Oct;113(4):1520-1532. doi: 10.1007/s10266-025-01078-5. Epub 2025 Mar 6.
PubMed 40048130
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT03827551
- Acronym / sponsor ID
- PARKIDENT / CHUBX 2018/44
- Conditions
- Oral Health, Parkinson Disease
- Keywords
- Oral Health, Parkinson Disease, Tooth cavities, Saliva, Mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Capionis, France Parkinson Association
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 1 Feb 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.
This is a prospective interventional clinical study whose main objective is to determine the impact of oral hygiene guidance on the oral health status of patients with Parkinson disease
Detailed description
Caries and periodontitis are infectious diseases that can eventually lead to the loss of the dental organ. The masticatory deficit engendered will have repercussions on the general state of the subject and on his quality of life (pains, difficulties of feeding which can cause nutritional deficiencies ...). The systematic review of the literature, despite low levels of evidence, shows that there is an influence of Parkinson's disease on oral health. Our goal is therefore to determine the impact of implementing appropriate oral hygiene measures on improving the quality of life of patients with Parkinson's disease.
This is a 40-patient, interventional, preliminary study that will rely on indicators of oral health status (DMF, Periodontal Index, presence of pathogenic bacteria), as well as a questionnaire measuring impact of oral conditions on patient well-being (OHIP-14). These data will be collected before and after the implementation of the hygiene measures, within a period of 6 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Patients | Experimental | Behavioral: Delivery of oral hygiene advices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient
- Patient with Parkinson disease
- Able to give written informed consent
- Affiliated to French health care system
Key exclusion criteria (5 listed)
- Patient under tutorship and curatorship
- Pregnant women
- Patient wearing subtotal or total dental prosthesis
- Antibiotic treatment or antiseptic mouthwashes in the month prior to sampling
- Patient with less than 6 teeth distributed on maxilla and mandible
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 |
|---|---|---|
| Delivery of oral hygiene advicesPatients will benefit from hygiene advice and maintenance of good oral health. No treatment will be administered as part of this study. Patients will continue their usual treatment according to the contraindications. Patients will benefit from salivary sampling and a collection of oral bacteria contained in the dental plaque using paper tips. These reviews will be conducted during the Inclusion Visit and the 6 month Follow-Up Visit. | Behavioural | Parkinson's Patients |
Primary outcome
Decayed Missing Filled (DMF) index score
Time frame: 6 months after inclusion
Min value : 0 (good oral health), Max value : 32
Presence of cariogenic bacteria in saliva and dental film
Time frame: 6 months after inclusion
Streptococcus mutans and Lactobacillus
Presence of periodontopathogenic bacteria in saliva and dental film
Time frame: 6 months after inclusion
Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus
8 secondary outcomes
Decayed Missing Filled (DMF) index score
Time frame: Inclusion visit (Day 0)
Presence of cariogenic bacteria in saliva and dental film
Time frame: Inclusion visit (Day 0)
Presence of periodontopathogenic bacteria in saliva and dental film
Time frame: Inclusion visit (Day 0)
Change of Oral Health Impact Profile-14 (OHIP-14)
Time frame: Inclusion Visit (Day 0) and 6 month after
Change of Geriatric/General Oral Health Assessment Index (GOHAI)
Time frame: Inclusion Visit (Day 0) and 6 month after
Saliva pH
Time frame: Inclusion Visit (Day 0) and 6 month after
Quantification of saliva flow
Time frame: Inclusion Visit (Day 0) and 6 month after
Change of Community Periodontal Index of Treatment Needs (CPITN)
Time frame: Inclusion Visit (Day 0) and 6 month after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 42249009Samot J, Courtin E, Guehl D, Damon-Perriere N, Branchard O, Saint-Jean M, Chuy V, Ella B, Badet MC. Periodontal health in a longitudinal French cohort of people with Parkinson's disease. Sci Rep. 2026 Jun 5. doi: 10.1038/s41598-026-55641-3. Online ahead of print.
- Derived from this study: PubMed 40048130Donnet L, Claisse O, Samot J. Serotype and distribution of adhesion genes in Streptococcus mutans isolated from people with Parkinson's disease. Odontology. 2025 Oct;113(4):1520-1532. doi: 10.1007/s10266-025-01078-5. Epub 2025 Mar 6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery of oral hygiene advices in people with Oral Health and Parkinson Disease, run by University Hospital, Bordeaux 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 5 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: finished, as of the sponsor's last update on 28 Sep 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decayed Missing Filled (DMF) index score (time frame: 6 months after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827551, which also lists 2 linked publications.
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 28 Sep 2021.