Oral Health for Healthy Cognitive Aging

Not Applicable

Active, not recruiting

• Conditions: Malocclusion; Dementia
• Interventions: Procedure: Dental occlusion restoration; Procedure: Orthodontic treatment of malocclusion

• Registration Number: NCT02986386
• Lead Sponsor: Universidad de Granada

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-08
• Primary Completion: 2023-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wait list control 1	Dental occlusion restoration	Group of patients that will be evaluated until they receive the dental occlusion restoration procedure.
Intervention 2	Orthodontic treatment of malocclusion	Orthodontic treatment of malocclusion.
Wait list control 2	Orthodontic treatment of malocclusion	Group of patients that will be evaluated until they receive the orthodontic treatment of malocclusion.
Intervention 1	Dental occlusion restoration	Dental occlusion restoration by placement of dental implants and prosthesis on missing teeth.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Facultad de Odontología; 🇪🇸 Granada, Spain