Oral Health for Healthy Cognitive Aging (SOECS)
Primary Purpose
Malocclusion, Dementia
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dental occlusion restoration
Orthodontic treatment of malocclusion
Sponsored by
About this trial
This is an interventional supportive care trial for Malocclusion focused on measuring Dental Occlusion, Oral Health, Mastication, Dementia, Psychological health
Eligibility 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.
Sites / Locations
- Facultad de Odontología
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Other
Arm Label
Intervention 1
Wait list control 1
Intervention 2
Wait list control 2
Arm Description
Dental occlusion restoration by placement of dental implants and prosthesis on missing teeth.
Group of patients that will be evaluated until they receive the dental occlusion restoration procedure.
Orthodontic treatment of malocclusion.
Group of patients that will be evaluated until they receive the orthodontic treatment of malocclusion.
Outcomes
Primary Outcome Measures
Change of occlusion units
Number of teeth occluding with opposing teeth
Change of cerebral activity
Functional MRI
Change of cognitive function
Verbal fluency
Change of frame of mind
Beck test
Change of resting brain activity
Electroencephalographic activity
Secondary Outcome Measures
Full Information
NCT ID
NCT02986386
First Posted
November 23, 2016
Last Updated
December 2, 2022
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT02986386
Brief Title
Oral Health for Healthy Cognitive Aging
Acronym
SOECS
Official Title
Oral Health for Healthy Cognitive Aging
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Dementia
Keywords
Dental Occlusion, Oral Health, Mastication, Dementia, Psychological health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention 1
Arm Type
Experimental
Arm Description
Dental occlusion restoration by placement of dental implants and prosthesis on missing teeth.
Arm Title
Wait list control 1
Arm Type
Other
Arm Description
Group of patients that will be evaluated until they receive the dental occlusion restoration procedure.
Arm Title
Intervention 2
Arm Type
Experimental
Arm Description
Orthodontic treatment of malocclusion.
Arm Title
Wait list control 2
Arm Type
Other
Arm Description
Group of patients that will be evaluated until they receive the orthodontic treatment of malocclusion.
Intervention Type
Procedure
Intervention Name(s)
Dental occlusion restoration
Intervention Description
Placement of dental implants by surgical intervention followed, after a healing period of 2 months, by fabrication and installation of implant supported dental prosthesis
Intervention Type
Procedure
Intervention Name(s)
Orthodontic treatment of malocclusion
Intervention Description
Orthodontic therapy to treat malocclusion
Primary Outcome Measure Information:
Title
Change of occlusion units
Description
Number of teeth occluding with opposing teeth
Time Frame
Baseline, 6, 12 and 36 months
Title
Change of cerebral activity
Description
Functional MRI
Time Frame
Baseline, 6, 12 and 36 months
Title
Change of cognitive function
Description
Verbal fluency
Time Frame
Baseline, 6, 12 and 36 months
Title
Change of frame of mind
Description
Beck test
Time Frame
Baseline, 6, 12 and 36 months
Title
Change of resting brain activity
Description
Electroencephalographic activity
Time Frame
Baseline, 6, 12 and 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Galindo-Moreno, DDS, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Odontología
City
Granada
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23254518
Citation
Akazawa Y, Kitamura T, Fujihara Y, Yoshimura Y, Mitome M, Hasegawa T. Forced mastication increases survival of adult neural stem cells in the hippocampal dentate gyrus. Int J Mol Med. 2013 Feb;31(2):307-14. doi: 10.3892/ijmm.2012.1217. Epub 2012 Dec 18.
Results Reference
background
PubMed Identifier
24128078
Citation
Elsig F, Schimmel M, Duvernay E, Giannelli SV, Graf CE, Carlier S, Herrmann FR, Michel JP, Gold G, Zekry D, Muller F. Tooth loss, chewing efficiency and cognitive impairment in geriatric patients. Gerodontology. 2015 Jun;32(2):149-56. doi: 10.1111/ger.12079. Epub 2013 Oct 16.
Results Reference
background
PubMed Identifier
23763956
Citation
Gil-Montoya JA, Ponce G, Sanchez Lara I, Barrios R, Llodra JC, Bravo M. Association of the oral health impact profile with malnutrition risk in Spanish elders. Arch Gerontol Geriatr. 2013 Nov-Dec;57(3):398-402. doi: 10.1016/j.archger.2013.05.002. Epub 2013 Jun 10.
Results Reference
background
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Oral Health for Healthy Cognitive Aging
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