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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05077618
Collaborator
(none)
94
1
17.9
5.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: sampling of dental plaque and blood sample during the treatment

Study Design

Study Type:
Observational
Anticipated Enrollment :
94 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Oral Bacterial and Viral Mapping by Dental Plaque in Elderly Patients With and Without Alzheimer's Disease(ORal MICrobiology in Alzheimer's Patients)
Anticipated Study Start Date :
Nov 2, 2021
Anticipated Primary Completion Date :
May 2, 2023
Anticipated Study Completion Date :
May 2, 2023

Arms and Interventions

Arm Intervention/Treatment
patients with Alzheimer's disease

47 cases (patients with Alzheimer's disease)

Other: sampling of dental plaque and blood sample during the treatment
sampling of dental plaque and blood sample analysed on day 1

patients without Alzheimer's disease

47 patients without Alzheimer's disease

Outcome Measures

Primary Outcome Measures

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

  1. Oral status presence of dentures [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nice Nice Chu de Nice France 06000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT05077618
Other Study ID Numbers:
  • 21-AOI-05
  • 2021-A01501-40
First Posted:
Oct 14, 2021
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021