Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000004561p
Ethics application status
Not yet submitted
Date submitted
10/10/2023
Date registered
8/01/2024
Date last updated
8/01/2024
Date data sharing statement initially provided
8/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study for smart dental hygiene (the Smart toothbrush) in aged care facilities
Scientific title
A pilot study for smart dental hygiene (the Smart toothbrush) in aged care facilities
Secondary ID [1] 310771 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Health 331730 0
Condition category
Condition code
Oral and Gastrointestinal 328477 328477 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
The study has two stages. Stage 1 seeks to familiarise staff and residents with the use of a Smart toothbrush (SmartBrush). In this stage, the Smartbrush will be used as an electric toothbrush. Stage 2, is the actual trial, it will use all the features of a Smartbrush (i.e., Toothbrush and App), to investigate the acceptability of an Smartbrush linked to an IT application that tracks the brush time, pressure and places cleaned in mouth. In this way the project investigates the use and acceptability of both an Smartbrush and an IT application that seeks to support improved oral hygiene

Stage 1.
• Participants will attend a screening visit including an oral examination by an oral health professional from Monash Health Dental Service.
This examination will determine the health and cleanliness of participants’ teeth and mouth at baseline, by recording on the dental chart the extent of plaque and the extent of gum bleeding.
• At the first appointment, participants will be provided with oral hygiene instructions (e.g., demonstration by oral health professional), including how to properly brush their teeth with a Smart toothbrush, which will be given to them. The approximate duration of the first appointment will be about 30 minutes.
• On entry to the study, a complete dental clean will be conducted
• Participants will be asked to maintain regular oral hygiene throughout the study using the Smart toothbrush (e.g., brush for 2 minutes at least once a day).
• At the end of this familiarization stage, participants will be asked to have a one-to-one conversation with a research team member so they can discuss any difficulties participants may be experiencing with the use of the Smart toothbrush and offer possible solutions.

The main reason for this stage is that, before starting the actual trial, we need to be sure that the participants are using the Smart toothbrush properly.

Stage 2,
• Participants will be provided with a tablet screen displayed to help them count down the time they spent brushing, and guide where to brush in their mouth so all their teeth are cleaned.
• Participants will be asked to maintain regular oral hygiene, including brushing in the morning and at night, for the duration of the 4-week study using the Smart toothbrush (e.g., brush for 2 minutes).
• At the end of Stage 2, participants will be invited to another one-to-one 30 min structured interview with a research team member so they can tell them what was good or bad about the brush and if they think it is useful to help you clean their teeth, and to understand if the display with the timer and brush position guide was helpful.
• Participants will be asked to maintain regular oral hygiene throughout the study using the Smartbrush.
• A last visit will be arranged when another full oral examination will be carried out and the cleanliness of their teeth and mouth will be recorded again.
* To assess or monitor adherence to the Smart toothbrushing brush data analytics will be used.
Intervention code [1] 327177 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336299 0
Acceptability of smart toothbrushes for aged care facilities residents.
Timepoint [1] 336299 0
4 weeks after the commencement of the trial
Primary outcome [2] 336300 0
Oral hygiene
Timepoint [2] 336300 0
2 weeks and 4 weeks after commencement.
Secondary outcome [1] 427747 0
Change in the oral hygiene of participants as measured by oral hygiene index.
Timepoint [1] 427747 0
2 weeks and 4 weeks after commencement

Eligibility
Key inclusion criteria
* Be 55 or more years of age
* Have the capacity to make informed consent to participate
* Be of good general health
* Have at least 10 natural teeth that are functional
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* For any reason is unable to provide informed consent
* Has been diagnosed with a significant disease requiring regular treatment e.g., chemotherapy or radiotherapy, or is immune-suppressed due to illness
* Is edentulous (no natural teeth) or has less than 10 teeth that are functional
* Has severe periodontal disease

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315001 0
Other
Name [1] 315001 0
Monash Health Dental Services
Country [1] 315001 0
Australia
Primary sponsor type
Other
Name
Monash Health
Address
122 Thomas Street, Dandenong VIC 3175
Country
Australia
Secondary sponsor category [1] 317021 0
None
Name [1] 317021 0
Address [1] 317021 0
Country [1] 317021 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313973 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 313973 0
122 Thomas Street, Dandenong VIC 3175
Ethics committee country [1] 313973 0
Australia
Date submitted for ethics approval [1] 313973 0
17/01/2024
Approval date [1] 313973 0
Ethics approval number [1] 313973 0

Summary
Brief summary
The oral health of residents in aged care facilities (ACF) is poor, contributing to infections, hospital admissions, and decreased quality of life. Furthermore, evidence associates poor oral health with a range of medical conditions, including aspiration pneumonia, bacteraemia, and stroke. A leading cause of mortality in ACFs is pneumonia where one in ten cases could be prevented by improving oral hygiene (Sjögren et al., 2008). Oral hygiene among ACF residents has been identified in Australia’s National Oral Health Plan 2015-2024 as being in a state of crisis (COAG, 2015). Less than 20% of aged care residents maintain oral hygiene without assistance and ACF staff are often under time pressure to do so thoroughly (Tynan et al, 2018).

Smartbrushes that record and transmit information about brushing patterns are not routinely deployed in ACFs. Yet, their use in ACFs promise better oral healthcare.
This study aims to investigate the appropriateness, suitability, and acceptability of smartbrushes for ACF residents and to design a program that analyses brushing practices of residents.

Research question: Are electronic toothbrushes (eBrush) and new IT applications (SmartBrush) acceptable tools for use by the elderly and their carers to support teeth cleaning?

• Objective 1: Assess the acceptability and usability of an eBrush and SmartBrush for oral hygiene amongst the older adults.

• Objective 2: Assess the acceptability and useability of an eBrush and SmartBrush by carers when providing assistance for oral hygiene to older adults.

References
Sjögren P, Nilsson E, Forsell M, Johansson O, Hoogstraate J. A Systematic Review of the Preventive Effect of Oral Hygiene on Pneumonia and Respiratory Tract Infection in Elderly People in Hospitals and Nursing Homes: Effect Estimates and Methodological Quality of Randomized Controlled Trials. JAGS 2008; 56: 2124–2130.
Council of Australian Governments. Oral Health Monitoring Group. Healthy Mouths, Healthy Lives: Australia’s National Oral Health Plan 2015–2024. Canberra:COAG, 2015. URL: http://www.coaghealthcouncil.gov.au/Publications/Reports/ArtMID/514/ArticleID/81/Australias-National-Oral-Health-Plan-2015-2024. Accessed Nov 2022.
Tynan A, Deeth L, McKenzie D. An integrated oral health program for rural residential aged care facilities: a mixed methods comparative study. BMC Health Serv Res. 2018;18:515.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129978 0
Prof Rodrigo Mariño
Address 129978 0
Monash Health, 122 Thomas Street, Dandenong, VIC 3175
Country 129978 0
Australia
Phone 129978 0
+61 437808554
Fax 129978 0
Email 129978 0
rodrigo.marino@monashhealth.org
Contact person for public queries
Name 129979 0
Prof Rodrigo Mariño
Address 129979 0
Monash Health, 122 Thomas Street, Dandenong, VIC 3175
Country 129979 0
Australia
Phone 129979 0
+61 437808554
Fax 129979 0
Email 129979 0
rodrigo.marino@monashhealth.org
Contact person for scientific queries
Name 129980 0
Prof Rodrigo Mariño
Address 129980 0
Monash Health, 122 Thomas Street, Dandenong, VIC 3175
Country 129980 0
Australia
Phone 129980 0
+61 437808554
Fax 129980 0
Email 129980 0
rodrigo.marino@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.