- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02986386
Oral Health for Healthy Cognitive Aging (SOECS)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Granada, Spain, 18071
- Facultad de Odontología
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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
Sponsor
Investigators
- Principal Investigator: Pablo Galindo-Moreno, DDS, PhD, Universidad de Granada
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOECS-905
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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