<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02986386</url>
  </required_header>
  <id_info>
    <org_study_id>SOECS-905</org_study_id>
    <nct_id>NCT02986386</nct_id>
  </id_info>
  <brief_title>Oral Health for Healthy Cognitive Aging</brief_title>
  <acronym>SOECS</acronym>
  <official_title>Oral Health for Healthy Cognitive Aging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Granada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oral health is a critical factor of systemic health, although usually forgotten. A potential&#xD;
      relation between cognitive deficits and oral diseases has been suggested. Adult cognitive&#xD;
      dysfunctions have a high impact, not only economic, but social and in the family environment.&#xD;
      Based on anatomical connectivity between the oral cavity and the central nervous system, the&#xD;
      proposed study hypothesizes that masticatory function is a relevant determinant of human&#xD;
      cognitive health. The restoration of canonical masticatory function and masticatory training&#xD;
      could help to delay the development of such conditions. This project will also test if&#xD;
      restoring phasic masticatory function improves the execution of cognitive tasks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective 1: To determine volumetric and anatomical changes of subcortical structures and&#xD;
      cortical areas involved in the masticatory circuit and superior cognitive functions.&#xD;
&#xD;
      Objective 2: To determine the functional and brain connectivity changes associated with&#xD;
      malocclusion and oral health.&#xD;
&#xD;
      Objective 3: To correlate the anatomic and functional changes associated with malocclusion&#xD;
      and oral health with the performance of cognitive tasks representative of those executed in&#xD;
      daily life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of occlusion units</measure>
    <time_frame>Baseline, 6, 12 and 36 months</time_frame>
    <description>Number of teeth occluding with opposing teeth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of cerebral activity</measure>
    <time_frame>Baseline, 6, 12 and 36 months</time_frame>
    <description>Functional MRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of cognitive function</measure>
    <time_frame>Baseline, 6, 12 and 36 months</time_frame>
    <description>Verbal fluency</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of frame of mind</measure>
    <time_frame>Baseline, 6, 12 and 36 months</time_frame>
    <description>Beck test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of resting brain activity</measure>
    <time_frame>Baseline, 6, 12 and 36 months</time_frame>
    <description>Electroencephalographic activity</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Malocclusion</condition>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Intervention 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dental occlusion restoration by placement of dental implants and prosthesis on missing teeth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait list control 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group of patients that will be evaluated until they receive the dental occlusion restoration procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orthodontic treatment of malocclusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait list control 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group of patients that will be evaluated until they receive the orthodontic treatment of malocclusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dental occlusion restoration</intervention_name>
    <description>Placement of dental implants by surgical intervention followed, after a healing period of 2 months, by fabrication and installation of implant supported dental prosthesis</description>
    <arm_group_label>Intervention 1</arm_group_label>
    <arm_group_label>Wait list control 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Orthodontic treatment of malocclusion</intervention_name>
    <description>Orthodontic therapy to treat malocclusion</description>
    <arm_group_label>Intervention 2</arm_group_label>
    <arm_group_label>Wait list control 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For Dental occlusion restoration groups: Need of, at least, two molar teeth&#xD;
             replacement in the same quadrant.&#xD;
&#xD;
          -  For Orthodontic treatment of malocclusion groups: Class I, II or III malocclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychoactive drug.&#xD;
&#xD;
          -  Central nervous system depressor.&#xD;
&#xD;
          -  Patients not willing or not able to consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pablo Galindo-Moreno, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Granada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Facultad de Odontología</name>
      <address>
        <city>Granada</city>
        <zip>18071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <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>
    <PMID>23254518</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24128078</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23763956</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Pablo Galindo-Moreno</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dental Occlusion</keyword>
  <keyword>Oral Health</keyword>
  <keyword>Mastication</keyword>
  <keyword>Dementia</keyword>
  <keyword>Psychological health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02986386
org study id: SOECS-905
nct id: NCT02986386
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change of occlusion units
time frame: Baseline, 6, 12 and 36 months
description: Number of teeth occluding with opposing teeth
measure: Change of cerebral activity
time frame: Baseline, 6, 12 and 36 months
description: Functional MRI
measure: Change of cognitive function
time frame: Baseline, 6, 12 and 36 months
description: Verbal fluency
measure: Change of frame of mind
time frame: Baseline, 6, 12 and 36 months
description: Beck test
measure: Change of resting brain activity
time frame: Baseline, 6, 12 and 36 months
description: Electroencephalographic activity
arm group label: Intervention 1
arm group type: Experimental
description: Dental occlusion restoration by placement of dental implants and prosthesis on missing teeth.
arm group label: Wait list control 1
arm group type: Other
description: Group of patients that will be evaluated until they receive the dental occlusion restoration procedure.
arm group label: Intervention 2
arm group type: Experimental
description: Orthodontic treatment of malocclusion.
arm group label: Wait list control 2
arm group type: Other
description: Group of patients that will be evaluated until they receive the orthodontic treatment of malocclusion.
intervention type: Procedure
intervention name: Dental occlusion restoration
description: Placement of dental implants by surgical intervention followed, after a healing period of 2 months, by fabrication and installation of implant supported dental prosthesis
arm group label: Intervention 1
arm group label: Wait list control 1
intervention type: Procedure
intervention name: Orthodontic treatment of malocclusion
description: Orthodontic therapy to treat malocclusion
arm group label: Intervention 2
arm group label: Wait list control 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Pablo Galindo-Moreno, DDS, PhD
role: Principal Investigator
affiliation: Universidad de Granada
facility: 
country: Spain
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.
PMID: 23254518
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.
PMID: 24128078
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.
PMID: 23763956
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Pablo Galindo-Moreno
investigator title: Professor
mesh term: Malocclusion
mesh term: Dementia