- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03214237
A Cross-sectional Study of the Oral Health of Elderly Inpatients in Acute and Subacute Hospitals in Northumberland and North Tyneside
August 8, 2020 updated by: Ben J Steel, Northumbria Healthcare NHS Foundation Trust
To provide a point-in-time measurement of the oral health of elderly inpatients across the trust (elderly defined here as over 70 years).
This will provide information about the number of teeth, need for restorative and periodontal treatment, and extractions, the health of the oral mucosa, quality of any dentures and hygiene of the teeth and dentures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Such information will allow identification of any problems with oral health in this hospital population, thereby allowing development of strategies and protocols for managing these problems.
There have been a number of studies examining these variables in elderly residents in care homes and a few in long term hospital settings (over 1 year admission), but only one in the UK previously in acute hospitals.
Therefore the published literature is sparse, and requires further data collection.
The oral health of the elderly, but particularly the institutionalized, is increasingly recognised for its important relationships with general health, wellbeing and quality of life.
This study will provide useful information to address these concerns.
Study Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cramlington, United Kingdom
- Northumbria Hospitals NHS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
older adults admitted to elderly care wards within the trust.
The hospital sites to be included are - NSECH, North Tyneside, Wansbeck, Hexham, Haltwhistle, Morpeth, Blyth, Alnwick and Berwick.
Description
Inclusion Criteria:
- age 70 or over and admitted to geriatric ward within the study area, able to consent
Exclusion Criteria:
- unable to consent, aged under 70
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants
Older adult inpatients on elderly care wards in acute hospitals within the Northumbria Hospitals NHS Foundation trust area, aged 70 or over and able to consent to involvement in the study
|
no intervention - cross-sectional observational only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
level of oral hygiene
Time Frame: 1 month
|
using modified plaque index
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
age
Time Frame: 1 month
|
age in years
|
1 month
|
gender
Time Frame: 1 month
|
male or female
|
1 month
|
condition of oral mucosa
Time Frame: 1 month
|
presence of absence of specific disease, e.g.
candidosis, leukoplakia
|
1 month
|
number of broken and decayed teeth
Time Frame: 1 month
|
a simple count of the number of decayed and broken teeth present
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ben J Steel, Northumbria Hospitals NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
July 31, 2018
Study Completion (Actual)
July 31, 2018
Study Registration Dates
First Submitted
July 3, 2017
First Submitted That Met QC Criteria
July 7, 2017
First Posted (Actual)
July 11, 2017
Study Record Updates
Last Update Posted (Actual)
August 11, 2020
Last Update Submitted That Met QC Criteria
August 8, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- IRAS217606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not planned to be shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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