SOECS: Oral Health for Healthy Cognitive Aging

Sponsor

Universidad de Granada (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02986386

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Malocclusion Dementia	Procedure: Dental occlusion restoration Procedure: Orthodontic treatment of malocclusion	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Oral Health for Healthy Cognitive Aging

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 1 Dental occlusion restoration by placement of dental implants and prosthesis on missing teeth.	Procedure: Dental occlusion restoration Placement of dental implants by surgical intervention followed, after a healing period of 2 months, by fabrication and installation of implant supported dental prosthesis
Other: Wait list control 1 Group of patients that will be evaluated until they receive the dental occlusion restoration procedure.	Procedure: Dental occlusion restoration Placement of dental implants by surgical intervention followed, after a healing period of 2 months, by fabrication and installation of implant supported dental prosthesis
Experimental: Intervention 2 Orthodontic treatment of malocclusion.	Procedure: Orthodontic treatment of malocclusion Orthodontic therapy to treat malocclusion
Other: Wait list control 2 Group of patients that will be evaluated until they receive the orthodontic treatment of malocclusion.	Procedure: Orthodontic treatment of malocclusion Orthodontic therapy to treat malocclusion

Outcome Measures

Primary Outcome Measures

Change of occlusion units [Baseline, 6, 12 and 36 months]
Number of teeth occluding with opposing teeth
Change of cerebral activity [Baseline, 6, 12 and 36 months]
Functional MRI
Change of cognitive function [Baseline, 6, 12 and 36 months]
Verbal fluency
Change of frame of mind [Baseline, 6, 12 and 36 months]
Beck test
Change of resting brain activity [Baseline, 6, 12 and 36 months]
Electroencephalographic activity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.