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Oral Health for Healthy Cognitive Aging (SOECS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02986386
Recruitment Status : Active, not recruiting
First Posted : December 8, 2016
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
Pablo Galindo-Moreno, Universidad de Granada

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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
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
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Primary Outcome Measures :
  1. Change of occlusion units [ Time Frame: Baseline, 6, 12 and 36 months ]
    Number of teeth occluding with opposing teeth

  2. Change of cerebral activity [ Time Frame: Baseline, 6, 12 and 36 months ]
    Functional MRI

  3. Change of cognitive function [ Time Frame: Baseline, 6, 12 and 36 months ]
    Verbal fluency

  4. Change of frame of mind [ Time Frame: Baseline, 6, 12 and 36 months ]
    Beck test

  5. Change of resting brain activity [ Time Frame: Baseline, 6, 12 and 36 months ]
    Electroencephalographic activity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986386


Locations
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Spain
Facultad de Odontología
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: Pablo Galindo-Moreno, DDS, PhD Universidad de Granada
More Information
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Publications:

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Responsible Party: Pablo Galindo-Moreno, Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02986386    
Other Study ID Numbers: SOECS-905
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022
Keywords provided by Pablo Galindo-Moreno, Universidad de Granada:
Dental Occlusion
Oral Health
Mastication
Dementia
Psychological health
Additional relevant MeSH terms:
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Malocclusion
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurocognitive Disorders
Mental Disorders
Tooth Diseases
Stomatognathic Diseases