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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Oral Health

Condition category

Condition code

Oral and Gastrointestinal

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]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Acceptability of smart toothbrushes for aged care facilities residents.

Timepoint [1]

4 weeks after the commencement of the trial

Primary outcome [2]

Oral hygiene

Timepoint [2]

2 weeks and 4 weeks after commencement.

Secondary outcome [1]

Change in the oral hygiene of participants as measured by oral hygiene index.

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Monash Health Dental Services

Address [1]

122 Thomas Street, Dandenong VIC 3175

Country [1]

Australia

Primary sponsor type

Other

Name

Monash Health

Address

122 Thomas Street, Dandenong VIC 3175

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

122 Thomas Street, Dandenong VIC 3175

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/01/2024

Approval date [1]

Ethics approval number [1]

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

Prof Rodrigo Mariño

Address

Monash Health, 122 Thomas Street, Dandenong, VIC 3175

Country

Australia

Phone

+61 437808554

Fax

[email protected]

Contact person for public queries

Name

Rodrigo Mariño

Address

Monash Health, 122 Thomas Street, Dandenong, VIC 3175

Country

Australia

Phone

+61 437808554

Fax

[email protected]

Contact person for scientific queries

Name

Rodrigo Mariño

Address

Monash Health, 122 Thomas Street, Dandenong, VIC 3175

Country

Australia

Phone

+61 437808554

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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