Oral Health for Healthy Cognitive Aging (SOECS)

December 2, 2022 updated by: Pablo Galindo-Moreno, Universidad de Granada
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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Granada, Spain, 18071
        • Facultad de Odontología

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention 1
Dental occlusion restoration by placement of dental implants and prosthesis on missing teeth.
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.
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.
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.
Orthodontic therapy to treat malocclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of occlusion units
Time Frame: Baseline, 6, 12 and 36 months
Number of teeth occluding with opposing teeth
Baseline, 6, 12 and 36 months
Change of cerebral activity
Time Frame: Baseline, 6, 12 and 36 months
Functional MRI
Baseline, 6, 12 and 36 months
Change of cognitive function
Time Frame: Baseline, 6, 12 and 36 months
Verbal fluency
Baseline, 6, 12 and 36 months
Change of frame of mind
Time Frame: Baseline, 6, 12 and 36 months
Beck test
Baseline, 6, 12 and 36 months
Change of resting brain activity
Time Frame: Baseline, 6, 12 and 36 months
Electroencephalographic activity
Baseline, 6, 12 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pablo Galindo-Moreno, DDS, PhD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

December 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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