MalocclusionSOECSNCT02986386
Oral Health for Healthy Cognitive Aging
A study testing Dental occlusion restoration and Orthodontic treatment of malocclusion in people with Malocclusion and Dementia, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malocclusion, Dementia
- What is being tested?
- Dental occlusion restoration and Orthodontic treatment of malocclusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2016to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Psychoactive drug.
- Central nervous system depressor.
- Patients not willing or not able to consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Malocclusion, Dementia
- Being tested
- Dental occlusion restoration, Orthodontic treatment of malocclusion
- Keywords
- Dental Occlusion, Oral Health, Mastication, Dementia, Psychological health
- Medical subject headings
- Malocclusion, Dementia, Bites and Stings, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental occlusion restorationProcedure or surgery
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 malocclusionProcedure or surgery
Orthodontic therapy to treat malocclusion
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | Dental occlusion restoration by placement of dental implants and prosthesis on missing teeth. Receives: Procedure: Dental occlusion restoration |
| Wait list control 1 | Other | Group of patients that will be evaluated until they receive the dental occlusion restoration procedure. Receives: Procedure: Dental occlusion restoration |
| Intervention 2 | Experimental | Orthodontic treatment of malocclusion. Receives: 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. Receives: Procedure: Orthodontic treatment of malocclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of occlusion units
Number of teeth occluding with opposing teeth
Measured: Baseline, 6, 12 and 36 months
Change of cerebral activity
Functional MRI
Measured: Baseline, 6, 12 and 36 months
Change of cognitive function
Verbal fluency
Measured: Baseline, 6, 12 and 36 months
Change of frame of mind
Beck test
Measured: Baseline, 6, 12 and 36 months
Change of resting brain activity
Electroencephalographic activity
Measured: Baseline, 6, 12 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2023
- Study completionDec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Galindo-Moreno, Universidad de Granada
- Investigators
- Pablo Galindo-Moreno, DDS, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986386
- Sponsor's protocol ID
- SOECS-905
- Acronym
- SOECS
- Status last verified
- May 2026
- First submitted
- 23 Nov 2016
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23254518Elsig 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.
PubMed 24128078Gil-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.
PubMed 23763956
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health for Healthy Cognitive Aging
- ClinicalTrials.gov ID
- NCT02986386
- Acronym / sponsor ID
- SOECS / SOECS-905
- Conditions
- Malocclusion, Dementia
- Keywords
- Dental Occlusion, Oral Health, Mastication, Dementia, Psychological health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2023 (actual)
- Study completion
- Dec 2025 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Procedure: Dental occlusion restorationDental occlusion restoration by placement of dental implants and prosthesis on missing teeth. |
| Wait list control 1 | Other | Procedure: Dental occlusion restorationGroup of patients that will be evaluated until they receive the dental occlusion restoration procedure. |
| Intervention 2 | Experimental | Procedure: Orthodontic treatment of malocclusionOrthodontic treatment of malocclusion. |
| Wait list control 2 | Other | Procedure: Orthodontic treatment of malocclusionGroup of patients that will be evaluated until they receive the orthodontic treatment of malocclusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Psychoactive drug.
- Central nervous system depressor.
- Patients not willing or not able to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental occlusion restorationPlacement of dental implants by surgical intervention followed, after a healing period of 2 months, by fabrication and installation of implant supported dental prosthesis | Procedure or surgery | Intervention 1, Wait list control 1 |
| Orthodontic treatment of malocclusionOrthodontic therapy to treat malocclusion | Procedure or surgery | Intervention 2, Wait list control 2 |
Primary outcome
Change of occlusion units
Time frame: Baseline, 6, 12 and 36 months
Number of teeth occluding with opposing teeth
Change of cerebral activity
Time frame: Baseline, 6, 12 and 36 months
Functional MRI
Change of cognitive function
Time frame: Baseline, 6, 12 and 36 months
Verbal fluency
Change of frame of mind
Time frame: Baseline, 6, 12 and 36 months
Beck test
Change of resting brain activity
Time frame: Baseline, 6, 12 and 36 months
Electroencephalographic activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 23254518Akazawa 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.
- Background: PubMed 24128078Elsig 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.
- Background: PubMed 23763956Gil-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.
Related trials for Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Galindo-Moreno, DDS, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental occlusion restoration and Orthodontic treatment of malocclusion in people with Malocclusion and Dementia, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of occlusion units (time frame: Baseline, 6, 12 and 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986386, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.