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Oral Bacterial and Viral Mapping by Dental Plaque in Elderly Patients With and Without Alzheimer's Disease(ORal MICrobiology in Alzheimer's Patients)

Analysis of the Periodontal Microbiota in Elderly Subjects With and Without Alzheimer's Disease: a Case Control Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04869904
Acronym
ORAMICAL
Enrollment
80
Registered
2021-05-03
Start date
2021-06-01
Completion date
2021-12-31
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Periodontitis

Brief 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. 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.

Interventions

PROCEDUREdental and plaque sampling

sampling of dental plaque and saliva during the treatment

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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)

Design outcomes

Primary

MeasureTime frameDescription
Quantification of periodontal bacterial and viral species from dental plaque samples9 monthsQuantification 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

Secondary

MeasureTime frameDescription
Oral status masticatory coefficient9 Monthspresence 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
Oral status mobilities1 dayMühlemann index (from 0 to 3)
Oral status caries involvement1 dayDMFT: number of Decayed Missing or Filled teeth (from 0 to 32)
Oral status presence of dentures9 Monthspresence 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
Periodontal status: clinical attachment (CAL)9 monthsclinical attachment (CAL): between the enamel-cement junction and the bottom of the pocket, measures in mm.
Periodontal status: bleeding on probing (BOP):9 monthsbleeding on probing (BOP): number of sites with bleeding divided by total number of sites measured x 100, measured as a percentage.
Periodontal status: plaque index (PI)9 monthsplaque index (PI): from 0 to 3
Periodontal status: pocket depth (PPS)9 monthspocket depth (PPS): between the gum line and the bottom of the pocket, measures in mm.

Countries

France

Contacts

Primary Contactleslie Borsa
leslie.borsa@univ-cotedazur.fr33625352362
Backup Contactlaurence Lupi
laurence.lupi@univ-cotedazur.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026