PeriodontitisORAMICALNCT04869904
Oral Bacterial and Viral Mapping by Dental Plaque in Elderly Patients With and Without Alzheimer's Disease(ORal MICrobiology in Alzheimer's Patients)
An observational study of Periodontitis and Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The neurological disorders that accompany aging represent a major public health problem. The management of these diseases is a major medical and social priority. This project is based on the assumption that the oral cavity represents a privileged observation space to address these issues. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Alzheimer Disease
- What is being tested?
- dental and plaque sampling
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Observational
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients coming to the Nice University Hospital (Autonomy Rehabilitation and Ageing Unit) for a memory consultation or a frailty screening
Who may be able to join
- Age greater than or equal to 70 years old
- Patient (or trusted person) having read and understood the study information note and signed the informed consent form
- Membership in a social security scheme
- For cases : Diagnosis of possible or probable Alzheimer's disease according to the DSM-V
Who cannot join
- Presence of a neurodegenerative pathology (excluding Alzheimer's disease for cases)
- Presence of a neurocognitive disorder (excluding Alzheimer's disease for the cases)
- Patient with or having had any kind of cancer, including oral or aerodigestive tract
- Patients with or having had autoimmune diseases (HIV, hepatitis)
- Patients with inflammatory diseases (such as rheumatoid arthritis (RA) or Gougerot-Sjogren's syndrome (GSJ))
- Patients with severe haemopathy
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- Patients with severe acute or chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, pulmonary, neuropsychiatric pathologies, judged by the investigator to be incompatible with the study, as all these pathologies may interfere with the results of the oral flora sampling
- Patients who have undergone oral surgery in the two months prior to sampling
- Patients treated with oral retinoids, bisphosphonates, oral anticoagulants or anticonvulsants
- Patients who have had anti-cancer or immunosuppressive chemotherapy within the last 6 months
- Patient who has had antibiotic or anti-inflammatory treatment in the last 4 weeks
- A history of treatments (drugs and probiotics) taken in the month prior to sampling will be taken, as well as a record of toxic habits (tobacco, alcohol, other)
Trial locations and contacts
1 site in 1 country.
laurence Lupi contact
France1 site
Nice University Hospital
Nice, 06000
Leslie BORSA, borsa.l@chu-nice.fr
leslie Borsa
About this study
Official title: Analysis of the Periodontal Microbiota in Elderly Subjects With and Without Alzheimer's Disease: a Case Control Study
The neurological disorders that accompany aging represent a major public health problem. The management of these diseases is a major medical and social priority. This project is based on the assumption that the oral cavity represents a privileged observation space to address these issues. The mouth is a site of easy access for painless sampling; there is therefore a major interest in identifying early oral infectious markers of the development or evolution of senile dementia. In addition to the interest of an early oral diagnosis, the mapping of the oral microbial flora in the demented elderly would allow a better understanding, prevention or even control of the evolution of neurodegenerative diseases. The final objective of our approach is to characterize the oral pathogens, or more probably the group of oral pathogens, which are significantly associated with Alzheimer's disease.
- Conditions
- Periodontitis, Alzheimer Disease
- Being tested
- dental and plaque sampling
- Medical subject headings
- Periodontitis, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental and plaque samplingProcedure or surgery
sampling of dental plaque and saliva during the treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with Alzheimer's disease | Not described Receives: Procedure: dental and plaque sampling | |
| patients without Alzheimer's disease | Not described Receives: Procedure: dental and plaque sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of periodontal bacterial and viral species from dental plaque samples
Quantification of periodontal bacterial and viral species by microfluidic multiplex PCR-Biomark HD system Microfluidigm 9 Herpes viruses = HSV-1 and 2 (or HHV-1 and -2), VZV (or HHV-3), EBV (or HHV-4), CMV (or HHV-5), HHV-6A, HHV-6B, HHV-7, HHV-8 (or Kaposi virus) 16 periodontal bacteria = Porphyromonas gingivalis, Tannerella forsythensis, Treponema denticola, Prevotella intermedia, Campylobacter rectus, Fusobacterium nucleatum, Prevotella nigrescens, Eubacterium nodatum, Peptostreptococcus micros, Prevotella melaninogenica, Aa, Actinomyces naeslundii, Eikenella corrodens, Streptococcus mitis, Streptococcus oralis, Streptococcus sanguis
For each species:
Less than 25 CT (Cycle Treshold): positive More than 30 CT (Cycle Treshold): negative Between 25 and 30 CT (Cycle Treshold): need to increase significance by using an additional primer CT: allows to determine the number of copies of each bacterial or viral species
Measured: 9 months
Secondary outcomes (9)
Oral status presence of dentures
presence of dentures: Yes/No masticatory coefficient: Coefficient from 1 to 5% assigned to each tooth according to its function, sum of all coefficients gives the result mobilities: Mühlemann index (from 0 to 3) caries involvement: DMFT
Measured: 9 Months
Oral status presence of dentures
presence of dentures: Yes/No
Measured: 9 Months
Oral status masticatory coefficient
presence of dentures: Yes/No masticatory coefficient: Coefficient from 1 to 5% assigned to each tooth according to its function, sum of all coefficients gives the result
Measured: 9 Months
Oral status mobilities
Mühlemann index (from 0 to 3)
Measured: 1 day
Oral status caries involvement
DMFT: number of Decayed Missing or Filled teeth (from 0 to 32)
Measured: 1 day
Periodontal status: pocket depth (PPS)
pocket depth (PPS): between the gum line and the bottom of the pocket, measures in mm.
Measured: 9 months
Periodontal status: clinical attachment (CAL)
clinical attachment (CAL): between the enamel-cement junction and the bottom of the pocket, measures in mm.
Measured: 9 months
Periodontal status: bleeding on probing (BOP):
bleeding on probing (BOP): number of sites with bleeding divided by total number of sites measured x 100, measured as a percentage.
Measured: 9 months
Periodontal status: plaque index (PI)
plaque index (PI): from 0 to 3
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869904
- Sponsor's protocol ID
- 21Odonto02
- Acronym
- ORAMICAL
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Periodontal Microbiota in Elderly Subjects With and Without Alzheimer's Disease: a Case Control Study
- ClinicalTrials.gov ID
- NCT04869904
- Acronym / sponsor ID
- ORAMICAL / 21Odonto02
- Conditions
- Periodontitis, Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 May 2021 (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 neurological disorders that accompany aging represent a major public health problem. The management of these diseases is a major medical and social priority. This project is based on the assumption that the oral cavity represents a privileged observation space to address these issues. The mouth is a site of easy access for painless sampling; there is therefore a major interest in identifying early oral infectious markers of the development or evolution of senile dementia. In addition to the interest of an early oral diagnosis, the mapping of the oral microbial flora in the demented elderly would allow a better understanding, prevention or even control of the evolution of neurodegenerative diseases. The final objective of our approach is to characterize the oral pathogens, or more probably the group of oral pathogens, which are significantly associated with Alzheimer's disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Alzheimer's disease | – | Procedure: dental and plaque sampling |
| patients without Alzheimer's disease | – | Procedure: dental and plaque sampling |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients coming to the Nice University Hospital (Autonomy Rehabilitation and Ageing Unit) for a memory consultation or a frailty screening
Key inclusion criteria (4 listed)
- Age greater than or equal to 70 years old
- Patient (or trusted person) having read and understood the study information note and signed the informed consent form
- Membership in a social security scheme
- For cases : Diagnosis of possible or probable Alzheimer's disease according to the DSM-V
Key exclusion criteria (12 listed)
- Presence of a neurodegenerative pathology (excluding Alzheimer's disease for cases)
- Presence of a neurocognitive disorder (excluding Alzheimer's disease for the cases)
- Patient with or having had any kind of cancer, including oral or aerodigestive tract
- Patients with or having had autoimmune diseases (HIV, hepatitis)
- Patients with inflammatory diseases (such as rheumatoid arthritis (RA) or Gougerot-Sjogren's syndrome (GSJ))
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 |
|---|---|---|
| dental and plaque samplingsampling of dental plaque and saliva during the treatment | Procedure or surgery | Patients with Alzheimer's disease, patients without Alzheimer's disease |
Primary outcome
Quantification of periodontal bacterial and viral species from dental plaque samples
Time frame: 9 months
Quantification of periodontal bacterial and viral species by microfluidic multiplex PCR-Biomark HD system Microfluidigm 9 Herpes viruses = HSV-1 and 2 (or HHV-1 and -2), VZV (or HHV-3), EBV (or HHV-4), CMV (or HHV-5), HHV-6A, HHV-6B, HHV-7, HHV-8 (or Kaposi virus) 16 periodontal bacteria = Porphyromonas gingivalis, Tannerella forsythensis, Treponema denticola, Prevotella intermedia, Campylobacter rectus, Fusobacterium nucleatum, Prevotella nigrescens, Eubacterium nodatum, Peptostreptococcus micros, Prevotella melaninogenica, Aa, Actinomyces naeslundii, Eikenella corrodens, Streptococcus mitis, Streptococcus oralis, Streptococcus sanguis For each species: Less than 25 CT (Cycle Treshold): positive More than 30 CT (Cycle Treshold): negative Between 25 and 30 CT (Cycle Treshold): need to increase significance by using an additional primer CT: allows to determine the number of copies of each bacterial or viral species
9 secondary outcomes
Oral status presence of dentures
Time frame: 9 Months
Oral status presence of dentures
Time frame: 9 Months
Oral status masticatory coefficient
Time frame: 9 Months
Oral status mobilities
Time frame: 1 day
Oral status caries involvement
Time frame: 1 day
Periodontal status: pocket depth (PPS)
Time frame: 9 months
Periodontal status: clinical attachment (CAL)
Time frame: 9 months
Periodontal status: bleeding on probing (BOP):
Time frame: 9 months
Periodontal status: plaque index (PI)
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- 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.
laurence Lupi contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice 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 12 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: status not confirmed, as of the sponsor's last update on 3 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact leslie Borsa (33625352362, leslie.borsa@univ-cotedazur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of periodontal bacterial and viral species from dental plaque samples (time frame: 9 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 3 May 2021.