ANZCTR - Registration

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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]

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

Public Health

Condition category

Condition code

Oral and Gastrointestinal

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]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in overall plaque levels as recorded using Turesky Modified Quigley Hein Index

Timepoint [1]

immediately after use & 2 weeks

Secondary outcome [1]

Change in gingival margin plaque levels as recorded using Marginal Plaque Index

Timepoint [1]

immediately after use & 2 weeks

Secondary outcome [2]

Acceptability
- assessed by participant feedback questionnaire designed specifically for this study

Timepoint [2]

2 weeks

Secondary outcome [3]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Dental Hospital of Melbourne - Carlton

Recruitment postcode(s) [1]

3053 - Carlton

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of State Development, Business and Innovation

Address [1]

Level 35, 121 Exhibition Street
Melbourne VIC 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Government body

Name [1]

Dental Health Services Victoria

Address [1]

720 Swanston St, Carlton VIC 3053

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Dental School Human Ethics Advisory Group

Ethics committee address [1]

Office for Research Ethics & Integrity
Level 3, 780 Elizabeth St
The University of Melbourne
VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/06/2016

Approval date [1]

01/08/2016

Ethics approval number [1]

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

A/Prof Rodrigo Marino

Address

Oral Health CRC
The University of Melbourne
Level 5, 720 Swanston Street
Carlton VIC 3053

Country

Australia

Phone

+61 3 9341 1558

Fax

r.marino@unimelb.edu.au

Contact person for public queries

Name

Callum MacLeod

Address

Project Manager
APS Innovations Pty Ltd
41 / 756 Burwood Hwy, Ferntree Gully VIC 3156

Country

Australia

Phone

+61 3 9752 2144

Fax

callumm@apsinnovations.com.au

Contact person for scientific queries

Name

Rodrigo Marino

Address

Oral Health CRC
The University of Melbourne
Level 5, 720 Swanston Street
Carlton VIC 3053

Country

Australia

Phone

+61 3 9341 1558

Fax

r.marino@unimelb.edu.au

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

No additional documents have been identified.

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