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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis; Alzheimer Disease
• Intervention / Treatment: Procedure: dental and plaque sampling

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: leslie Borsa; Phone Number: 33625352362; Email: leslie.borsa@univ-cotedazur.fr
• Study Contact Backup: Name: laurence Lupi; Email: laurence.lupi@univ-cotedazur.fr

Study Locations

• France
  • Nice, France, 06000
    • Nice University Hospital
    • Contact: Leslie BORSA; Email: borsa.l@chu-nice.fr
    • Principal Investigator: Leslie BORSA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Alzheimer's disease	Procedure: dental and plaque sampling; sampling of dental plaque and saliva during the treatment
patients without Alzheimer's disease	Procedure: dental and plaque sampling; sampling of dental plaque and saliva during the treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	9 Months
Oral status presence of dentures	presence of dentures: Yes/No	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	9 Months
Oral status mobilities	Mühlemann index (from 0 to 3)	1 day
Oral status caries involvement	DMFT: number of Decayed Missing or Filled teeth (from 0 to 32)	1 day
Periodontal status: pocket depth (PPS)	pocket depth (PPS): between the gum line and the bottom of the pocket, measures in mm.	9 months
Periodontal status: clinical attachment (CAL)	clinical attachment (CAL): between the enamel-cement junction and the bottom of the pocket, measures in mm.	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.	9 months
Periodontal status: plaque index (PI)	plaque index (PI): from 0 to 3	9 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Neurodegenerative Diseases; Dementia; Tauopathies; Periodontitis; Alzheimer Disease
• Other Study ID Numbers: 21Odonto02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No