<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/NCT03295435</url>
  </required_header>
  <id_info>
    <org_study_id>301916</org_study_id>
    <nct_id>NCT03295435</nct_id>
  </id_info>
  <brief_title>Composition of Functional Tooth Units and Nutrient Intake in Older Men</brief_title>
  <acronym>CHAMP</acronym>
  <official_title>Associations Between the Composition of Functional Tooth Units and Nutrient Intake in Older Men: the Concord Health and Ageing in Men Project.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sydney</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sydney</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Various definitions of poor dentition in older adults has been linked with inadequate intake&#xD;
      of nutrients and poor diet quality. This study aims to look at the associations between poor&#xD;
      dentition as defined by the composition of functional tooth units, and dietary intake of&#xD;
      nutrients in community dwelling older men.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Poor dentition, defined by numbers of teeth, functional tooth units or edentulism has been&#xD;
      previously shown to be associated with poor intakes of nutrients in older adults, including&#xD;
      but not limited to vitamin C, calcium, fibre, protein, zinc and folate. Similar findings have&#xD;
      been found when poor dentition is defined by the presence of a prosthesis. Reasons for this&#xD;
      inverse relationship include poor denture quality, reduced chewing capacity, or the&#xD;
      inadequacy of prosthesis to replace natural teeth.&#xD;
&#xD;
      However limited studies have looked at how the composition (natural verses prosthetic) of&#xD;
      functional tooth units is associated with nutrient intake. A cross sectional analysis of a&#xD;
      cohort of male older adults, participating in an ongoing longitudinal study, was conducted to&#xD;
      investigate nutrition and oral health associations, including the relationship between the&#xD;
      composition of functional tooth units and nutrient intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2014</start_date>
  <completion_date type="Actual">July 13, 2016</completion_date>
  <primary_completion_date type="Actual">July 13, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary intake of nutrients</measure>
    <time_frame>45 minute interview on 1 day (cross-sectional).</time_frame>
    <description>A diet history was performed, and data entered into a database which provided daily average nutrient intakes.</description>
  </primary_outcome>
  <enrollment type="Actual">781</enrollment>
  <condition>Oral Health of Older Men</condition>
  <condition>Dietary Assessment of Older Men</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Composition of functional tooth units</intervention_name>
    <description>Composition of functional tooth units measured by trained oral health therapists and was categorised into 3 groups:&#xD;
Group A: Natural units only Group B: Natural &amp; Prosthetic units present Group C: No natural units present</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is a subset of a ongoing longitudinal study, that start in 2005. Men&#xD;
        over the age of 70 years on the electoral roll for geographical locations within the Canada&#xD;
        Bay area of Sydney, NSW were invited to participate. The only exclusion criteria was living&#xD;
        in an aged care facility at time of recruitment.&#xD;
&#xD;
        The follow up this study is based on, invited participants to be involved in a fourth wave&#xD;
        of assessments. Anyone who had moved into an aged care facility was included. However those&#xD;
        who had moved outside of the Sydney, had died, previously withdrawn or refused to&#xD;
        participate, (but remained active), were excluded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moved inter or intrastate (moved out of study area)&#xD;
&#xD;
          -  Death&#xD;
&#xD;
          -  Refused to participate&#xD;
&#xD;
          -  previously withdrawn&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>78 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Cumming, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sydney</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Centre for Education and Research on Ageing</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2234</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <link>
    <url>http://www.foodstandards.gov.au/science/monitoringnutrients/ausnut/Pages/ausnut2007.aspx</url>
    <description>Nutrient Database used to determine daily nutrient intakes of diet history</description>
  </link>
  <reference>
    <citation>de Andrade FB, de Franca Caldas A Jr, Kitoko PM. Relationship between oral health, nutrient intake and nutritional status in a sample of Brazilian elderly people. Gerodontology. 2009 Mar;26(1):40-5. doi: 10.1111/j.1741-2358.2008.00220.x. Epub 2008 Feb 19.</citation>
    <PMID>18298586</PMID>
  </reference>
  <reference>
    <citation>Hildebrandt GH, Dominguez BL, Schork MA, Loesche WJ. Functional units, chewing, swallowing, and food avoidance among the elderly. J Prosthet Dent. 1997 Jun;77(6):588-95. doi: 10.1016/s0022-3913(97)70100-8.</citation>
    <PMID>9185051</PMID>
  </reference>
  <reference>
    <citation>Ervin RB, Dye BA. The effect of functional dentition on Healthy Eating Index scores and nutrient intakes in a nationally representative sample of older adults. J Public Health Dent. 2009 Fall;69(4):207-16. doi: 10.1111/j.1752-7325.2009.00124.x.</citation>
    <PMID>19453869</PMID>
  </reference>
  <reference>
    <citation>Shinkai RS, Hatch JP, Rugh JD, Sakai S, Mobley CC, Saunders MJ. Dietary intake in edentulous subjects with good and poor quality complete dentures. J Prosthet Dent. 2002 May;87(5):490-8. doi: 10.1067/mpr.2002.124093.</citation>
    <PMID>12070511</PMID>
  </reference>
  <reference>
    <citation>Ueno M, Yanagisawa T, Shinada K, Ohara S, Kawaguchi Y. Masticatory ability and functional tooth units in Japanese adults. J Oral Rehabil. 2008 May;35(5):337-44. doi: 10.1111/j.1365-2842.2008.01847.x.</citation>
    <PMID>18405269</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>September 24, 2017</last_update_submitted>
  <last_update_submitted_qc>September 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diet</keyword>
  <keyword>Oral Health</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Dentition</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data is be available for researchers.</ipd_description>
    <ipd_time_frame>Data is currently available</ipd_time_frame>
    <ipd_access_criteria>Data access request will be reviewed by Chief Investigators. All requester's will be required to sign a data access agreement.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03295435
org study id: 301916
nct id: NCT03295435
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Various definitions of poor dentition in older adults has been linked with inadequate intake
      of nutrients and poor diet quality. This study aims to look at the associations between poor
      dentition as defined by the composition of functional tooth units, and dietary intake of
      nutrients in community dwelling older men.
Poor dentition, defined by numbers of teeth, functional tooth units or edentulism has been
      previously shown to be associated with poor intakes of nutrients in older adults, including
      but not limited to vitamin C, calcium, fibre, protein, zinc and folate. Similar findings have
      been found when poor dentition is defined by the presence of a prosthesis. Reasons for this
      inverse relationship include poor denture quality, reduced chewing capacity, or the
      inadequacy of prosthesis to replace natural teeth.

      However limited studies have looked at how the composition (natural verses prosthetic) of
      functional tooth units is associated with nutrient intake. A cross sectional analysis of a
      cohort of male older adults, participating in an ongoing longitudinal study, was conducted to
      investigate nutrition and oral health associations, including the relationship between the
      composition of functional tooth units and nutrient intake.
observational model: Cohort
time perspective: Cross-Sectional
measure: Dietary intake of nutrients
time frame: 45 minute interview on 1 day (cross-sectional).
description: A diet history was performed, and data entered into a database which provided daily average nutrient intakes.
intervention type: Other
intervention name: Composition of functional tooth units
description: Composition of functional tooth units measured by trained oral health therapists and was categorised into 3 groups:
Group A: Natural units only Group B: Natural & Prosthetic units present Group C: No natural units present
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 78 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Cumming, PhD
role: Principal Investigator
affiliation: University of Sydney
facility: 
country: Australia
url: http://www.foodstandards.gov.au/science/monitoringnutrients/ausnut/Pages/ausnut2007.aspx
description: Nutrient Database used to determine daily nutrient intakes of diet history
citation: de Andrade FB, de Franca Caldas A Jr, Kitoko PM. Relationship between oral health, nutrient intake and nutritional status in a sample of Brazilian elderly people. Gerodontology. 2009 Mar;26(1):40-5. doi: 10.1111/j.1741-2358.2008.00220.x. Epub 2008 Feb 19.
PMID: 18298586
citation: Hildebrandt GH, Dominguez BL, Schork MA, Loesche WJ. Functional units, chewing, swallowing, and food avoidance among the elderly. J Prosthet Dent. 1997 Jun;77(6):588-95. doi: 10.1016/s0022-3913(97)70100-8.
PMID: 9185051
citation: Ervin RB, Dye BA. The effect of functional dentition on Healthy Eating Index scores and nutrient intakes in a nationally representative sample of older adults. J Public Health Dent. 2009 Fall;69(4):207-16. doi: 10.1111/j.1752-7325.2009.00124.x.
PMID: 19453869
citation: Shinkai RS, Hatch JP, Rugh JD, Sakai S, Mobley CC, Saunders MJ. Dietary intake in edentulous subjects with good and poor quality complete dentures. J Prosthet Dent. 2002 May;87(5):490-8. doi: 10.1067/mpr.2002.124093.
PMID: 12070511
citation: Ueno M, Yanagisawa T, Shinada K, Ohara S, Kawaguchi Y. Masticatory ability and functional tooth units in Japanese adults. J Oral Rehabil. 2008 May;35(5):337-44. doi: 10.1111/j.1365-2842.2008.01847.x.
PMID: 18405269
responsible party type: Sponsor
sharing ipd: Yes
ipd description: De-identified data is be available for researchers.
ipd time frame: Data is currently available
ipd access criteria: Data access request will be reviewed by Chief Investigators. All requester's will be required to sign a data access agreement.