Oral Health for Healthy Cognitive Aging

Dementia Clinical Trial

— SOECS  

Official title:

Oral Health for Healthy Cognitive Aging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02986386
• Other study ID #: SOECS-905
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dementia
• Malocclusion

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