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

NCT04869904 | Unknown

• 1 other identifier: 21Odonto02
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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

  9 months

Secondary Outcomes (9)

• Oral status presence of dentures

  9 Months

• Oral status presence of dentures

  9 Months

• Oral status masticatory coefficient

  9 Months

• Oral status mobilities

  1 day

• Oral status caries involvement

  1 day

Study Arms (2)

Patients with Alzheimer's disease

Procedure: dental and plaque sampling

patients without Alzheimer's disease

Procedure: dental and plaque sampling

Interventions

dental and plaque sampling PROCEDURE

sampling of dental plaque and saliva during the treatment

Patients with Alzheimer's disease; patients without Alzheimer's disease

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients coming to the Nice University Hospital (Autonomy Rehabilitation and Ageing Unit) for a memory consultation or a frailty screening

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva and plaque

MeSH Terms

Conditions

Periodontitis; Alzheimer Disease

Interventions

Dental Health Services

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

leslie Borsa

CONTACT

33625352362; leslie.borsa@univ-cotedazur.fr

laurence Lupi

CONTACT

laurence.lupi@univ-cotedazur.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 3, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 31, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)