Oral Health for Healthy Cognitive Aging

NCT ID: NCT02986386

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Malocclusion Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention 1

Dental occlusion restoration by placement of dental implants and prosthesis on missing teeth.

Group Type EXPERIMENTAL

Dental occlusion restoration

Intervention Type 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

Wait list control 1

Group of patients that will be evaluated until they receive the dental occlusion restoration procedure.

Group Type OTHER

Dental occlusion restoration

Intervention Type 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

Intervention 2

Orthodontic treatment of malocclusion.

Group Type EXPERIMENTAL

Orthodontic treatment of malocclusion

Intervention Type PROCEDURE

Orthodontic therapy to treat malocclusion

Wait list control 2

Group of patients that will be evaluated until they receive the orthodontic treatment of malocclusion.

Group Type OTHER

Orthodontic treatment of malocclusion

Intervention Type PROCEDURE

Orthodontic therapy to treat malocclusion

Interventions

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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

Intervention Type PROCEDURE

Orthodontic treatment of malocclusion

Orthodontic therapy to treat malocclusion

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Pablo Galindo-Moreno

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pablo Galindo-Moreno, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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Facultad de Odontología

Granada, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 23254518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24128078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23763956 (View on PubMed)

Other Identifiers

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SOECS-905

Identifier Type: -

Identifier Source: org_study_id

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