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Trial registered on ANZCTR


Registration number
ACTRN12617001646336p
Ethics application status
Submitted, not yet approved
Date submitted
25/11/2017
Date registered
21/12/2017
Date last updated
21/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Oral care intervention in people with and without dementia living in residential aged care
Scientific title
Effect of oral care intervention on type and load of oral microorganisms associated with aspiration pneumonia and ill health in people with and without dementia living in residential aged care
Secondary ID [1] 293409 0
Nil known
Universal Trial Number (UTN)
U1111-1205-4670
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aspiration pneumonia 305561 0
Dementia 305562 0
Oral health 305563 0
Condition category
Condition code
Public Health 304786 304786 0 0
Health promotion/education
Neurological 304787 304787 0 0
Dementias
Respiratory 304788 304788 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 304789 304789 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Effect of oral care intervention on type and load of oral bacteria in people with and without dementia living in residential care
This project evaluates changes in the type and load of bacteria in adults in residential aged care, before and after a 6-week period of daily oral care. One non-invasive oral swab will be taken from each of four places in the mouth: the tongue surface, hard palate, gum line, and cheek before and after the 6-week period of daily oral care. The oral swabs will be taken, face-to-face, from each individual resident by nurses, or care staff under their supervision, who know each resident well. Participating residents will be placed in one of two groups: (I) experimental (2-minutes of teeth cleaning after meals or daily cleaning of dentures), and (ii) control (usual/standard care).
Residents in the experimental group will be given an Oral B electric toothbrush that is set on low intensity and timed to brush for 2 minutes, indicating a change in quadrant (upper right teeth, lower right teeth, upper left teeth, lower left teeth) every 30 seconds. This electric toothbrush also can be used to clean dentures. If residents are apprehensive about using the electric toothbrush, they will be given a regular soft-bristled toothbrush and assisted to brush for 2 minutes using strategies such as brushing to a favourite recorded song. A fluoridated toothpaste will be used; the brand, mouth feel, and taste may differ to address residents' preferences. Teeth brushing will be done twice per day, following breakfast and the evening meal. Staff do not feel they can accommodate brushing after lunch. The use of the electric toothbrushes will be monitored through an App which is downloaded to an android telephone. Data will be downloaded following every 30 brushings (15 days) by a designated staff nurse. Care staff who are working with each resident will assist them as needed in the teeth brushing and/or denture cleaning. Denture cleaning will be done each night before sleep. Care staff will be asked to document, on a daily care sheet, if dentures also are cleaned before breakfast, following residents' request.
Residents in the control (usual care) group will be assisted by care staff to brush their teeth following breakfast and dinner, and/or clean their dentures each day. The duration of the teeth brushing will not be timed but observations suggest that it will be notably less than 2 minutes/time. The care staff will indicate on a daily care sheet what type of oral care was provided each day and when dentures were cleaned.
The mode of delivery for residents in both the experimental and control groups will be face-to-face and for a period of 6 weeks. The oral care will take place in each resident's room.
Intervention code [1] 299653 0
Early detection / Screening
Intervention code [2] 299654 0
Prevention
Comparator / control treatment
Control group - residents who have agreed to participate in the oral swab procedure but who do not wish to participate in the ongoing oral health study to ensure 2-minutes of teeth cleaning after meals. These residents will live in the same residential aged care community. Their oral care will be the usual (standard) care provided by staff. For the purposes of this study, usual or standard care is described as (a) teeth cleaning at least once per day for an average of less than one minute, or (b) periodic (not every day) cleaning of dentures.

Control group
Active

Outcomes
Primary outcome [1] 304047 0
Change in type of oral microorganisms, as documented through real-time polymerase chain reaction (qPCR) assays using 7 primers for major oral pathogens.
Timepoint [1] 304047 0
Types of oral microorganisms prior to the 6-week intervention commencement will be compared to types of oral microorganisms immediately following the intervention period.
Primary outcome [2] 304048 0
Change in load of oral microorganisms, as documented through real-time polymerase chain reaction (qPCR) assays using a universal primer for oral pathogens.
Timepoint [2] 304048 0
The load of oral microorganisms prior to the 6-week intervention commencement will be compared to the load of oral microorganisms immediately following the intervention period.
Primary outcome [3] 304049 0
Proportion of participants with an improvement in oral health, as measured by repeat screening with the Oral health Assessment Tool.
Timepoint [3] 304049 0
At 6-weeks after the daily oral care intervention
Secondary outcome [1] 340787 0
Change in instances of unplanned hospital transfers or admissions to hospital related to clinical signs of aspiration pneumonia, as documented from residents' medical charts by each Facility Manager
Timepoint [1] 340787 0
Instances during the 6-months prior to the 6-week intervention commencement will be compared to instances throughout the 6-week intervention period.

Eligibility
Key inclusion criteria
All adults who live in the Fred French or Peace Haven residential aged care communities
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to remain alert or to follow simple, 1-step directions
2. Head-of-bed is restricted to < 30 degrees
3. Unable to open mouth

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We estimate that we will need 33 participants in each of the intervention and control groups to obtain statistically significant results. With 33 residents in each group, we will have >80% power to reveal a significant group x time interaction in oral bacterial load (estimated using procedures documented by Ferozali, Johnson & Cavagnaro, 2007). The reported annual bed turnover rate ranges from 20-30%, we will use the conservative figure of a 15% 6-month drop out rate due to death or relocation. We plan a sample of 38 residents in each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 18151 0
7250 - Newstead

Funding & Sponsors
Funding source category [1] 298034 0
Charities/Societies/Foundations
Name [1] 298034 0
Tasmanian Community Fund (TCF)
Address [1] 298034 0
GPO Box 1350
Hobart 7001
Tasmania
Country [1] 298034 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Office of Research Services
Private Bag 1
Hobart
Tasmania 7001
Country
Australia
Secondary sponsor category [1] 297106 0
None
Name [1] 297106 0
N/A
Address [1] 297106 0
N/A
Country [1] 297106 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299062 0
Health and Medical Human Research Ethics Committee (HREC)
Ethics committee address [1] 299062 0
Office of the Deputy Vice-Chancellor (Research)
Office of Research Services
University of Tasmania
Private Bag 1
Hobart
Tasmania 7001
Ethics committee country [1] 299062 0
Australia
Date submitted for ethics approval [1] 299062 0
29/11/2017
Approval date [1] 299062 0
Ethics approval number [1] 299062 0
Ethics committee name [2] 299167 0
Health and Medical Human Research Ethics Committee (Tasmania)
Ethics committee address [2] 299167 0
Office of the Deputy Vice-Chancellor (Research)
Office of Research Services
University of Tasmania
Private Bag 1
Hobart
Tasmania 7001
Ethics committee country [2] 299167 0
Australia
Date submitted for ethics approval [2] 299167 0
29/11/2017
Approval date [2] 299167 0
Ethics approval number [2] 299167 0

Summary
Brief summary
This project seeks to improve and maintain the oral health of people who move into residential aged care by providing an objective way to document they are receiving effective oral care. The project developed as the result of a suggestion by staff at the Fred French and Peace Haven Homes of Masonic Care Tasmania, Inc. during their participation in a current federally-funded initiative with researchers at the University of Tasmania.
The purpose of this project is to determine the impact of a 6-week period of 2-minutes of teeth cleaning after meals, or daily denture cleaning, on the type and load of oral bacteria in the mouths of residents. The hypothesis is that the 6-week intervention will lead to a change in the type and load of oral bacteria, increase residents' oral health, and reduce their risk of aspiration pneumonia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79158 0
Dr Lynette Goldberg
Address 79158 0
Wicking Dementia Research and Education Centre
University of Tasmania
Private Bag 143
Hobart
Tasmania 7001
Country 79158 0
Australia
Phone 79158 0
+61 03 6226 6953
Fax 79158 0
Email 79158 0
Lyn.Goldberg@utas.edu.au
Contact person for public queries
Name 79159 0
Dr Lynette Goldberg
Address 79159 0
Wicking Dementia Research and Education Centre
University of Tasmania
Private Bag 143
Hobart
Tasmania 7001
Country 79159 0
Australia
Phone 79159 0
+61 0362266953
Fax 79159 0
Email 79159 0
Lyn.Goldberg@utas.edu.au
Contact person for scientific queries
Name 79160 0
Dr Lynette Goldberg
Address 79160 0
Wicking Dementia Research and Education Centre
University of Tasmania
Private Bag 143
Hobart
Tasmania 7001
Country 79160 0
Australia
Phone 79160 0
+61 0362266953
Fax 79160 0
Email 79160 0
Lyn.Goldberg@utas.edu.au

No data has been provided for results reporting
Summary results
Not applicable