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

Alzheimer Disease Clinical Trial

— ORAMICAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04869904
• Other study ID #: 21Odonto02
• Status: Not yet recruiting
• Start date: June 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: leslie Borsa
• Phone: 33625352362
• Email: leslie.borsa[@]univ-cotedazur.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Periodontitis

Intervention

Procedure:
• dental and plaque sampling
sampling of dental plaque and saliva during the treatment

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

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