None listed
Conditions
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.
Interventions
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
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
Sponsors
APS Innovations Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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
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
Outcome results
None listed