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Trial registered on ANZCTR


Registration number
ACTRN12615001345572
Ethics application status
Approved
Date submitted
17/11/2015
Date registered
9/12/2015
Date last updated
25/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study To Test A New Method Of Improving Oral Hygiene In Adults
Scientific title
Does the plaque removal device (PRD) improve oral hygiene in adults?
Secondary ID [1] 287673 0
CT-2015-CTN-02261-1-v2
Universal Trial Number (UTN)
U1111-1175-5800
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Hygiene 296507 0
Public Health 296723 0
Condition category
Condition code
Oral and Gastrointestinal 296764 296764 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to use the Plaque Removal Device (PRD) for two minutes twice daily, ideally morning and night, with standard toothpaste, for a period of two weeks in lieu of their normal oral hygiene routine.

PRD use involves;
- lightly wetting the PRD under running water, and applying toothpaste to the full length of both sides of the PRD using the applicator provided
- placing the PRD in the mouth & aligning teeth on one side of mouth between PRD bristles
- chew normally for 1min, then remove the PRD from the mouth
- placing the PRD in the mouth & aligning teeth on opposite side of mouth between PRD bristles
- chew normally for 1min, then remove the PRD from the mouth
- rinsing PRD under warm running water & hanging on hook supplied to air dry between uses
- recording PRD usage in diary of device use
- phone review will also be undertaken with participants at halfway (1 week) into the study
Intervention code [1] 293086 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296393 0
Change in overall plaque levels as recorded using Turesky Modified Quigley Hein Index
Timepoint [1] 296393 0
immediately after use & 2 weeks
Secondary outcome [1] 319110 0
Change in gingival margin plaque levels as recorded using Marginal Plaque Index
Timepoint [1] 319110 0
immediately after use & 2 weeks
Secondary outcome [2] 319111 0
Acceptability
- assessed by participant feedback questionnaire designed specifically for this study
Timepoint [2] 319111 0
2 weeks
Secondary outcome [3] 319112 0
Suitability
- adverse outcomes, if any, assessed by clinician during clinical examination or reported by participant
- durability (visual deterioration, if any) assessed by examination of PRD, returned at conclusion of 2 week trial period
Timepoint [3] 319112 0
2 weeks

Eligibility
Key inclusion criteria
Able-bodied adult participants:
- be over 18 years of age
- have the capacity to make informed consent to participate
Adults who require carer support to maintain oral hygiene participants:
- as above, plus
- require carer support to maintain oral hygiene
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients meeting any of the following criteria will be excluded from the study:
- has an intellectual disability or for any reason is unable to provide informed consent
- has a prior diagnosis of heart disease
- has been diagnosed with a significant disease requiring treatment e.g. chemotherapy or radiotherapy treatment or patient is immunodeficient due to illness or medication
- has severe periodontal disease
- is edentulous (no natural teeth) or has less than 20 teeth
- has dentures
- is currently taking Warfarin or other anticoagulants
- any evidence of an incompetent swallowing mechanism

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)
Only applicable for randomised controlled trials. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Only applicable for randomised controlled trials.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
number of participants: 72 (36 able-bodied adults, and 36 adults who require a carer to maintain oral hygiene)

As the PRD has not been tested previously, data was used from available studies to provide mean and standard deviation to use in the power calculation. The data was from studies that examined the effectiveness of manual and electric toothbrushes to remove plaque as measured by the Turesky Modified Quigley Hein Index. To detect a change of 0.5 unit in plaque score using the Turesky Modified Quigley Hein Index (power 0.9, a= 0.05), 30 participants per group are required in the PRD study. To allow for a 20 per cent loss to follow up, 36 participants per group will be recruited. The participants will be drawn from patients already attending RDHM (Special Needs Clinic and Primary Care Clinic).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2016
Actual
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4486 0
The Royal Dental Hospital of Melbourne - Carlton
Recruitment postcode(s) [1] 10670 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 292247 0
Government body
Name [1] 292247 0
Department of State Development, Business and Innovation
Country [1] 292247 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
APS Innovations Pty Ltd
Address
41 / 756 Burwood Highway, Ferntree Gully VIC 3156
Country
Australia
Secondary sponsor category [1] 290924 0
None
Name [1] 290924 0
Address [1] 290924 0
Country [1] 290924 0
Other collaborator category [1] 278671 0
Government body
Name [1] 278671 0
Dental Health Services Victoria
Address [1] 278671 0
720 Swanston St, Carlton VIC 3053
Country [1] 278671 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293711 0
Melbourne Dental School Human Ethics Advisory Group
Ethics committee address [1] 293711 0
Office for Research Ethics & Integrity
Level 3, 780 Elizabeth St
The University of Melbourne
VIC 3010
Ethics committee country [1] 293711 0
Australia
Date submitted for ethics approval [1] 293711 0
03/06/2016
Approval date [1] 293711 0
01/08/2016
Ethics approval number [1] 293711 0

Summary
Brief summary
BACKGROUND & RATIONALE
In 2013, Dental Health Services Victoria and APS Innovations were awarded a grant from the Department of State Development, Business and Innovation to develop a new Plaque Removal Device (PRD) and undertake a feasibility study. The PRD is an alternative for people who cannot use a toothbrush due to manual dexterity issues. This is a three year project (2013-2016) and the PRD is being produced, made using the same materials in the production of standard manual toothbrushes. The PRD will be ready for testing in early 2016.

This pilot study aims to:
1. Determine the impact of the PRD on oral hygiene in two groups:
i. Able-bodied adults, and
ii. Adults who require carer support to maintain oral hygiene.
2. Assess the suitability of the PRD for use in adults.

STUDY OBJECTIVES
1. To determine changes in oral hygiene after two weeks of use of the PRD.
2. To determine the changes in plaque when using the PRD, immediately after use, and after two weeks of use twice daily
i. Overall plaque levels
ii. At gingival margins
3. To determine acceptability of the use of the PRD by participants and carers, as appropriate, over the two week period, with twice daily use.
i. To identify any adverse outcomes from using the PRD on the soft and hard tissues of the oral cavity
ii. To examine the durability of the PRD.

STUDY DESIGN
Type of study
This is a pilot study using pre- and post-design to determine user acceptability and impacts on oral hygiene using the PRD in a small number of adults (able-bodied, and those who require carer support to maintain oral hygiene).

STUDY SETTING
This study will be undertaken at The Royal Dental Hospital of Melbourne and other settings such as aged care facilities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60994 0
A/Prof Rodrigo Marino
Address 60994 0
Oral Health CRC
The University of Melbourne
Level 5, 720 Swanston Street
Carlton VIC 3053
Country 60994 0
Australia
Phone 60994 0
+61 3 9341 1558
Fax 60994 0
Email 60994 0
[email protected]
Contact person for public queries
Name 60995 0
Callum MacLeod
Address 60995 0
Project Manager
APS Innovations Pty Ltd
41 / 756 Burwood Hwy, Ferntree Gully VIC 3156
Country 60995 0
Australia
Phone 60995 0
+61 3 9752 2144
Fax 60995 0
Email 60995 0
[email protected]
Contact person for scientific queries
Name 60996 0
Rodrigo Marino
Address 60996 0
Oral Health CRC
The University of Melbourne
Level 5, 720 Swanston Street
Carlton VIC 3053
Country 60996 0
Australia
Phone 60996 0
+61 3 9341 1558
Fax 60996 0
Email 60996 0
[email protected]

No information has been provided regarding IPD availability


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
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