Oral Health of Older MenCHAMPNCT03295435
Composition of Functional Tooth Units and Nutrient Intake in Older Men
An observational study of Oral Health of Older Men and Dietary Assessment of Older Men, run by University of Sydney at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 78 years and older, men only
- Conditions the study is for
- Oral Health of Older Men, Dietary Assessment of Older Men
- What is being tested?
- Composition of functional tooth units
- Type of treatment
- Pill or oral medicine
- How many people
- 781 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Aug 2014to 13 Jul 2016
- Phase
- Observational
- 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 78 years and older
- Men only
- No healthy volunteers
- Older adult
Study population: The study population is a subset of a ongoing longitudinal study, that start in 2005. Men over the age of 70 years on the electoral roll for geographical locations within the Canada Bay area of Sydney, NSW were invited to participate. The only exclusion criteria was living in an aged care facility at time of recruitment. The follow up this study is based on, invited participants to be involved in a fourth wave of assessments. Anyone who had moved into an aged care facility was included. However those who had moved outside of the Sydney, had died, previously withdrawn or refused to participate, (but remained active), were excluded.
Who may be able to join
- -
Who cannot join
- Moved inter or intrastate (moved out of study area)
- Death
- Refused to participate
- previously withdrawn
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Centre for Education and Research on Ageing
Sydney, New South Wales, 2234
About this study
Official title: Associations Between the Composition of Functional Tooth Units and Nutrient Intake in Older Men: the Concord Health and Ageing in Men Project.
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.
Read the detailed description
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.
- Being tested
- Composition of functional tooth units
- Keywords
- Diet, Oral Health, Nutrition, Dentition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composition of functional tooth unitsOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary intake of nutrients
A diet history was performed, and data entered into a database which provided daily average nutrient intakes.
Measured: 45 minute interview on 1 day (cross-sectional).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start5 Aug 2014
- Primary completion13 Jul 2016
- Study completion13 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral Health of Older MenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Cumming, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295435
- Sponsor's protocol ID
- 301916
- Acronym
- CHAMP
- Status last verified
- Sep 2017
- First submitted
- 24 Sep 2017
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data is be available for researchers.
Publications
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.
PubMed 18298586Hildebrandt 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.
PubMed 9185051Ervin 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.
PubMed 19453869Shinkai 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.
PubMed 12070511Ueno 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.
PubMed 18405269
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between the Composition of Functional Tooth Units and Nutrient Intake in Older Men: the Concord Health and Ageing in Men Project.
- ClinicalTrials.gov ID
- NCT03295435
- Acronym / sponsor ID
- CHAMP / 301916
- Keywords
- Diet, Oral Health, Nutrition, Dentition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 781 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 13 Jul 2016 (actual)
- Study completion
- 13 Jul 2016 (actual)
- First posted
- 27 Sep 2017 (actual)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 78 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population is a subset of a ongoing longitudinal study, that start in 2005. Men over the age of 70 years on the electoral roll for geographical locations within the Canada Bay area of Sydney, NSW were invited to participate. The only exclusion criteria was living in an aged care facility at time of recruitment. The follow up this study is based on, invited participants to be involved in a fourth wave of assessments. Anyone who had moved into an aged care facility was included. However those who had moved outside of the Sydney, had died, previously withdrawn or refused to participate, (but remained active), were excluded.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (4 listed)
- Moved inter or intrastate (moved out of study area)
- Death
- Refused to participate
- previously withdrawn
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 |
|---|---|---|
| Composition of functional tooth unitsComposition 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 | Other | – |
Primary outcome
Dietary intake of nutrients
Time frame: 45 minute interview on 1 day (cross-sectional).
A diet history was performed, and data entered into a database which provided daily average nutrient intakes.
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 27 Sep 2017.
- Background: PubMed 18298586de 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.
- Background: PubMed 9185051Hildebrandt 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.
- Background: PubMed 19453869Ervin 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.
- Background: PubMed 12070511Shinkai 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.
- Background: PubMed 18405269Ueno 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.
- Individual participant dataSharing planned: Yes. De-identified data is be available for researchers.
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.
Robert Cumming, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health of Older Men and Dietary Assessment of Older Men, run by University of Sydney at 1 site in Australia.
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 1 inclusion and 4 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 27 Sep 2017. 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 Australia. 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?
Dietary intake of nutrients (time frame: 45 minute interview on 1 day (cross-sectional).). 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 NCT03295435, which also lists 5 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 27 Sep 2017.