NCT02986386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

6.2 years

First QC Date

November 23, 2016

Last Update Submit

May 9, 2026

Conditions

Keywords

Dental OcclusionOral HealthMasticationDementiaPsychological health

Outcome Measures

Primary Outcomes (5)

  • Change of occlusion units

    Number of teeth occluding with opposing teeth

    Baseline, 6, 12 and 36 months

  • Change of cerebral activity

    Functional MRI

    Baseline, 6, 12 and 36 months

  • Change of cognitive function

    Verbal fluency

    Baseline, 6, 12 and 36 months

  • Change of frame of mind

    Beck test

    Baseline, 6, 12 and 36 months

  • Change of resting brain activity

    Electroencephalographic activity

    Baseline, 6, 12 and 36 months

Study Arms (4)

Intervention 1

EXPERIMENTAL

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

Procedure: Dental occlusion restoration

Wait list control 1

OTHER

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

Procedure: Dental occlusion restoration

Intervention 2

EXPERIMENTAL

Orthodontic treatment of malocclusion.

Procedure: Orthodontic treatment of malocclusion

Wait list control 2

OTHER

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

Procedure: Orthodontic treatment of malocclusion

Interventions

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 1Wait list control 1

Orthodontic therapy to treat malocclusion

Intervention 2Wait list control 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Psychoactive drug.
  • Central nervous system depressor.
  • Patients not willing or not able to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de OdontologĂ­a

Granada, Granada, 18071, Spain

Location

Related 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.

    PMID: 23254518BACKGROUND
  • 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.

    PMID: 24128078BACKGROUND
  • 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.

    PMID: 23763956BACKGROUND

MeSH Terms

Conditions

MalocclusionDementiaBites and StingsPsychological Well-Being

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPoisoningChemically-Induced DisordersWounds and InjuriesPersonal SatisfactionBehavior

Study Officials

  • Pablo Galindo-Moreno, DDS, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2016

First Posted

December 8, 2016

Study Start

November 1, 2016

Primary Completion

January 1, 2023

Study Completion

December 1, 2025

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations