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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02986386
Other study ID # SOECS-905
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date December 2025

Study information

Verified date May 2024
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date December 2025
Est. primary completion date January 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Orthodontic treatment of malocclusion
Orthodontic therapy to treat malocclusion

Locations

Country Name City State
Spain Facultad de Odontología Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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