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NCT Number: NCT05077618

Nalysis 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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, CHU de NICE, 06000, France

Location status: Recruiting

Location contact

Leslie BORSA

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

0492034702

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ge 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)

Treatment and study plan

sampling of dental plaque and blood sample during the treatment

Other

sampling of dental plaque and blood sample analysed on day 1

Primary outcomes

  1. Quantification of periodontal bacterial and viral species from dental plaque samples

    Time frame: day 1

    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

Secondary outcomes

  1. Oral status presence of dentures

    Time frame: day 1

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Leslie Borsa

CONTACT

[email protected]

0492034702

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: ORAMICAL

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Oct 14, 2021
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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