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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03295435




Registration number
NCT03295435
Ethics application status
Date submitted
24/09/2017
Date registered
27/09/2017
Date last updated
27/09/2017

Titles & IDs
Public title
Composition of Functional Tooth Units and Nutrient Intake in Older Men
Scientific title
Associations Between the Composition of Functional Tooth Units and Nutrient Intake in Older Men: the Concord Health and Ageing in Men Project.
Secondary ID [1] 0 0
301916
Universal Trial Number (UTN)
Trial acronym
CHAMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Health of Older Men 0 0
Dietary Assessment of Older Men 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Composition of functional tooth units

Other interventions: Composition of functional tooth units
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dietary intake of nutrients
Timepoint [1] 0 0
45 minute interview on 1 day (cross-sectional).

Eligibility
Key inclusion criteria
-
Minimum age
78 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Moved inter or intrastate (moved out of study area)
* Death
* Refused to participate
* previously withdrawn

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/07/2016
Sample size
Target
Accrual to date
Final
781
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Centre for Education and Research on Ageing - Sydney
Recruitment postcode(s) [1] 0 0
2234 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03295435
Trial related presentations / 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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Robert Cumming, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03295435