Clinical trial NCT02986386: Oral Health for Healthy Cognitive Aging
Official title: Oral Health for Healthy Cognitive Aging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malocclusion
Dementia
Keywords: Dental Occlusion
Oral Health
Mastication
Dementia
Psychological health
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change of occlusion units
timeFrame: Baseline, 6, 12 and 36 months
measure: Change of cerebral activity
timeFrame: Baseline, 6, 12 and 36 months
measure: Change of cognitive function
timeFrame: Baseline, 6, 12 and 36 months
measure: Change of frame of mind
timeFrame: Baseline, 6, 12 and 36 months
measure: Change of resting brain activity
timeFrame: Baseline, 6, 12 and 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Facultad de Odontología
Study officials:
affiliation: Universidad de Granada
name: Pablo Galindo-Moreno, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.