Dental Carotid Cognitive Study
关键词
抽象
描述
Periodontal Disease (PD) is present in 60+% of adults >65 years and is associated with tobacco smoking, diabetes, and atherosclerosis that worsen inflammation, comorbidities common in older people with mild to moderate cognitive impairment (MCI). Older MCI patients are prone to poor oral hygiene and dental health, which if untreated worsens inflammation-mediated brain and nervous system function, and accelerates progression to dementia. Asymptomatic carotid artery stenosis (ACAS) is often a silent disease detected in only ~10% of older adults, and may have a strong association with MCI. This study examines the effects of intensive therapy for periodontitis on cognition in high-risk older people with ACAS. Results could highlight PD as a readily modifiable risk factor for dementia.
This pilot study examines the hypothesis that intensive treatment of PD (IPT) in older people with MCI and ACAS will attenuate their cognitive decline by reducing oral microbial-mediated inflammation and improving cerebrovascular endothelial function that contribute to neurodegeneration-associated dementia.
The aims are to determine the effects of intensive compared to control PD treatment (randomized: IPT vs. CPT) in 60 MCI subjects with ACAS and PD on 1) Cognitive function (Primary Outcome) and quality of life (Secondary Outcome), and 2) The potential mechanisms mediating these effects
日期
| 最后验证: | 08/31/2019 |
| 首次提交: | 11/11/2018 |
| 提交的预估入学人数: | 11/25/2018 |
| 首次发布: | 11/27/2018 |
| 上次提交的更新: | 09/10/2019 |
| 最近更新发布: | 09/11/2019 |
| 实际学习开始日期: | 04/07/2019 |
| 预计主要完成日期: | 10/30/2020 |
| 预计完成日期: | 10/30/2021 |
状况或疾病
干预/治疗
Procedure: Standard treatment (control)
Procedure: Intensive Treatment
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Standard treatment (control) Dental evaluation and dental prophylaxis at baseline, 3, 6, and 9 months and standard oral hygiene instruction. | Procedure: Standard treatment (control) Dental evaluation at baseline, 3, 6, and 9 months. |
| Experimental: Intensive Treatment Dental evaluation at baseline, 3, 6, and 9 months. Plus one or more sessions as needed at baseline of full mouth supra- and sub-gingival scaling and root planing, plus oral hygiene instruction. Additional sessions as necessary to remove remaining local factors and treat inflammation and bacteria overgrowth. Additional evaluations and therapy at 2 months or as needed based on therapeutic response. If bleeding on probing levels do not decrease to <20% of sites following initial therapy or at subsequent visits, intermediate treatment visits will be scheduled. Each participant will be instructed to use half of a capful of 0.12% chlorhexidine twice a day during active treatment including two weeks beyond the treatment visit. | Procedure: Intensive Treatment Dental evaluation at baseline, 3, 6, and 9 months. Plus one or more sessions as needed at baseline of full mouth supra- and sub-gingival scaling and root planing, plus oral hygiene instruction. Additional sessions as necessary to remove remaining local factors and treat inflammation and bacteria overgrowth. Additional evaluations and therapy at 2 months or as needed based on therapeutic response. If bleeding on probing levels do not decrease to <20% of sites following initial therapy or at subsequent visits, intermediate treatment visits will be scheduled. Each participant will be instructed to use half of a capful of 0.12% chlorhexidine twice a day during active treatment including two weeks beyond the treatment visit. |
资格标准
| 有资格学习的年龄 | 60 Years 至 60 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age equal to or greater than 65 years. - Body Mass Index 18-35 kg/m2 - Mild to moderate periodontitis - Mild to moderate cognitive impairment on Montreal Cognitive Assessment (MoCA) -range greater than or equal to 17 and less than or equal to 26 (i.e., range from 17-26). - Detectable carotid plaque and carotid artery stenosis <70% as diagnosed by doppler ultrasound. - Able to perform prescribed dental hygiene and travel to medical center as required to participate in the study. Exclusion Criteria: - Inability to provide informed consent. - Subjects with inability to perform cognitive and other research testing - Prior stroke, depression (CESD >16), neurologic or psychiatric disease that would affect cognitive testing, participation, and compliance to the research study. - Subjects requiring chronic treatment with systemic corticosteroids or other systemic immunosuppressive drugs or drugs that would affect the dental treatments in the protocol are excluded. - Subjects requiring essential dental care (e.g., treatment for grossly decayed teeth, broken teeth, dental abscesses, peri-apical infections, other dental infections). - Inability to perform FDG-PET due to renal disease (eGFR <30 mL/min/1.75m2). - Receiving anticoagulant therapy (Warfarin) with an INR greater than 3.3 at time of dental treatment or with a bleeding disorder, or other diseases that may interfere with dental therapy. - Subjects with medical conditions that the clinicians feel would limit their ability to participate. |
结果
主要结果指标
1. Changes in performance on Montreal Cognitive Assessment (MoCA) [1 year]
次要成果指标
1. Presence of oral bacteria in saliva and dental plaque samples [1 year]
2. Presence of bacteria in stool samples [1 year]
3. Systemic inflammation [1 year]
4. Change from baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Metabolic Measure of Standard Uptake Value Ratio (SUVR) [1 year]
5. Changes in performance on Wechsler Adult Intelligence Scale (WAIS)-III Digit Span subtest [1 year]
6. Changes in performance on Hopkins Verbal Learning Test [1 year]
7. Changes in performance on Brief Visuospatial Memory test [1 year]
8. Changes in performance on Trail Making Test (A+B) [1 year]
9. Changes in performance on Controlled Oral Word Association Test [1 year]
10. Changes in performance on Boston Naming Test [1 year]
11. Changes in performance on Modified Wisconsin Card Sorting Test [1 year]
12. Changes in performance on Grooved Pegboard Test [1 year]
13. Changes in Composite Cognitive Function Score [1 year]
