NCT03295435

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
781

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2017

Enrollment Period

1.9 years

First QC Date

September 24, 2017

Last Update Submit

September 24, 2017

Conditions

Keywords

DietOral HealthNutritionDentition

Outcome Measures

Primary Outcomes (1)

  • Dietary intake of nutrients

    A diet history was performed, and data entered into a database which provided daily average nutrient intakes.

    45 minute interview on 1 day (cross-sectional).

Interventions

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

Eligibility Criteria

Age78 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may not qualify if:

  • Moved inter or intrastate (moved out of study area)
  • Death
  • Refused to participate
  • previously withdrawn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centre for Education and Research on Ageing

Sydney, New South Wales, 2234, Australia

Location

Related Publications (5)

  • 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: 18298586BACKGROUND
  • 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: 9185051BACKGROUND
  • 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: 19453869BACKGROUND
  • 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: 12070511BACKGROUND
  • 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: 18405269BACKGROUND

Study Officials

  • Robert Cumming, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2017

First Posted

September 27, 2017

Study Start

August 5, 2014

Primary Completion

July 13, 2016

Study Completion

July 13, 2016

Last Updated

September 27, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

De-identified data is be available for researchers.

Time Frame
Data is currently available
Access Criteria
Data access request will be reviewed by Chief Investigators. All requester's will be required to sign a data access agreement.

Locations