跳至主要内容
临床试验/NCT02986386
NCT02986386已完成不适用

Oral Health for Healthy Cognitive Aging

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Change of occlusion units

研究概览

简要总结

Oral health is a critical factor of systemic health, although usually forgotten. A potential relation between cognitive deficits and oral diseases has been suggested. Adult cognitive dysfunctions have a high impact, not only economic, but social and in the family environment. Based on anatomical connectivity between the oral cavity and the central nervous system, the proposed study hypothesizes that masticatory function is a relevant determinant of human cognitive health. The restoration of canonical masticatory function and masticatory training could help to delay the development of such conditions. This project will also test if restoring phasic masticatory function improves the execution of cognitive tasks.

详细描述

Objective 1: To determine volumetric and anatomical changes of subcortical structures and cortical areas involved in the masticatory circuit and superior cognitive functions.

Objective 2: To determine the functional and brain connectivity changes associated with malocclusion and oral health.

Objective 3: To correlate the anatomic and functional changes associated with malocclusion and oral health with the performance of cognitive tasks representative of those executed in daily life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For Dental occlusion restoration groups: Need of, at least, two molar teeth replacement in the same quadrant.
  • For Orthodontic treatment of malocclusion groups: Class I, II or III malocclusion.

排除标准

  • Psychoactive drug.
  • Central nervous system depressor.
  • Patients not willing or not able to consent.

研究组 & 干预措施

Intervention 2

Experimental

Orthodontic treatment of malocclusion.

干预措施: Orthodontic treatment of malocclusion (Procedure)

Intervention 1

Experimental

Dental occlusion restoration by placement of dental implants and prosthesis on missing teeth.

干预措施: Dental occlusion restoration (Procedure)

Wait list control 1

Other

Group of patients that will be evaluated until they receive the dental occlusion restoration procedure.

干预措施: Dental occlusion restoration (Procedure)

Wait list control 2

Other

Group of patients that will be evaluated until they receive the orthodontic treatment of malocclusion.

干预措施: Orthodontic treatment of malocclusion (Procedure)

结局指标

主要结局

Change of occlusion units

时间窗: Baseline, 6, 12 and 36 months

Number of teeth occluding with opposing teeth

Change of cerebral activity

时间窗: Baseline, 6, 12 and 36 months

Functional MRI

Change of cognitive function

时间窗: Baseline, 6, 12 and 36 months

Verbal fluency

Change of frame of mind

时间窗: Baseline, 6, 12 and 36 months

Beck test

Change of resting brain activity

时间窗: Baseline, 6, 12 and 36 months

Electroencephalographic activity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo Galindo-Moreno

Professor

Universidad de Granada

研究点 (2)

Loading locations...

相似试验