Analysis of the Periodontal Microbiota in Elderly Subjects With and Without Alzheimer's Disease: a Case Control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quantification of periodontal bacterial and viral species from dental plaque samples
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Quantification of periodontal bacterial and viral species from dental plaque samples
时间窗: 9 months
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
次要结局
- Oral status mobilities(1 day)
- Oral status presence of dentures(9 Months)
- Oral status caries involvement(1 day)
- Periodontal status: bleeding on probing (BOP):(9 months)
- Oral status masticatory coefficient(9 Months)
- Periodontal status: pocket depth (PPS)(9 months)
- Periodontal status: clinical attachment (CAL)(9 months)
- Periodontal status: plaque index (PI)(9 months)