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Trial registered on ANZCTR


Registration number
ACTRN12621001684819
Ethics application status
Approved
Date submitted
26/08/2021
Date registered
9/12/2021
Date last updated
9/12/2021
Date data sharing statement initially provided
9/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial comparing the efficacy of interdental oral irrigation devices with interdental brushes in adults with gingivitis
Scientific title
Comparison study, identifying statisticial differences in biofilm removal and gingival inflamation markers based upon the cleaning efficacy of interdental oral irrigation and interdental brushes in adults with gingivitis
Secondary ID [1] 305142 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Health 323393 0
Interdental biofilm 323394 0
Gingivitis 323395 0
Oral Biofilm 323396 0
Periodontal disease 323401 0
Condition category
Condition code
Oral and Gastrointestinal 320961 320961 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
Participants will be given taylored oral hygiene instruction on each device, either an interdental brush or an oral irrigation device prior to use. The interdental brush is in essence like a small "bottle" brush that comes in various sizes. The size specific to each individual trial participant will be professionally sized by the trial oral hygiene educators. The oral irrigation device is a high pressure water streaming device which focuses a controlled amount of water pressure on the interdental spaces. Both devices are designed to remove, food debris, biofilm (dental plaque) and remove bacterial toxins to the betterment of gingival health. Both devices are to be used in the participants home bathroom enviroment.
The oral hygiene educators have been calibrated and will have access to a "script" for the fundamental messages on safe and correct use that each participant must receive. The participant will be randomly allocated a device by the oral educator and this information will be noted by them and it is highly important that the participants don't let the clinical assessors know which device they are using at any time.

Participants will only be taught about either the interdental brushes or oral irrigation device prior to them commencing use with that implement for the specified time by the Oral hygiene educators. The educators are year 2 Dentistry students who are already AHPRA registered Oral Health Therapists with at least 3 years experience each as OHT's.

One to one personalised oral hygiene education for each device will be implemented in the dental chair with mirrors and the "touch to teach" method of education i.e. show, demostrate physically and the patient explains and demonstrates to the educator themselves to verify appropriate uptake of the correct technique. This session is expected to take no more than 20-25 minutes. The participant is expected to use each device at least once a day at a time convenient to them. The duration of use for each device is expected to be not more than 4-5 minutes per day for a four week period. The patient then returns, has their clinical parameters taken once again. At this point the participant is asked to return to the Interdental cleaning method they used before the trial for a "washout period" of two weeks. The the participant will return and receive the subsequent oral hygiene education for the device they have not yet used.

The adherance of the participant to the regime is self-motivated on their part. This is part of what we assess via the qualitative questionaire on their last visit of the trial to determine which device they found the easiest to use and felt was the most effective in cleaning inbetween their teeth.

The total timeline for the trial will be 5 visits over 12 weeks.









Intervention code [1] 321551 0
Prevention
Intervention code [2] 321552 0
Treatment: Devices
Intervention code [3] 321553 0
Behaviour
Comparator / control treatment
This is a cross over study. The same cohort of patients will have access to both devices over a set period of time and they will recieved calibrated individualised oral hygiene instruction with each device specific to their needs. The assessors of the oral biofim and gingival inflamation indicies will be blinded to which device the participant is using at any point in the study.
Control group
Active

Outcomes
Primary outcome [1] 328733 0
Any differences in the removal of oral biofilm interdentally by interdental brushes compared to oral irrigation devices.
Gingival inflammation assessed using the Modified papilla bleeding index.
Periodontal screening and recording (PSR) indicies will measure gingival coding according to this indicies, Rustogi modified navy plaque index will assess dental biofilm quality and quantity measurements.
All of these outcomes will be assessed as a composite outcome.
Timepoint [1] 328733 0
Visit 2 - Initial clinical parameters recorded (baseline)
Visit 3 - Clinical parameters recorded 4 weeks post-commencement of intervention 1
Visit 5 - Clinical parameters recorded 4 weeks post-commencement of intervention 2
Secondary outcome [1] 400180 0
Investigate participant preferences as a composite secondary outcome by using a ethics approved specific questionaire to pose questions regarding the ease of use for each device, which device is their preferred and which device motivates them more to clean interdentally.
Timepoint [1] 400180 0
This data is collected at the final appointment 12 weeks post-baseline via an ethics approved questionaire

Eligibility
Key inclusion criteria
1. Oral Disease status/ or disease group for study: Embrasure space of 2 or 3. PSR code<=3.
2. Gender: no restrictions
3. Age range: >18 years
4. At least 24 natural teeth
5.Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
2. Participants with a history of active periodontal disease with a PSR code of 4.
3. Participants with a history of diabetes, tobacco smoking, xerostomia (dry mouth), any form of chronic inflammatory disease.
4. Participants who have taken antibiotics within the past six weeks.
5. Participants currently experiencing psychological illness or other conditions which may interfere with their ability to understand the study requirements or interfere with their motivation to participate in the study, or the evaluation of the study outcome.
6. As the following medication(s) can have interactive effects and may interfere with the participant’s ability to meet the study requirements, they cannot be administered during the clinical study (anticoagulants, anti-convulsant, immunosuppressants, tricyclic antidepressants)
7. Participants that have a medical condition which inhibits their ability to safely use the OH tools, e.g. multiple sclerosis, Parkinson’s disease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation: 40 subjects would be enrolled into the study. A sample size calculation determined 34 participants were required for an effect size of 0.4 (medium sample size approach), with a=0.05 and ß=0.85 (G*Power sample calculation software). An additional 20% is included to allow for dropouts.
Analysis plan: The analysis will be performed using PRISM (Version 8) statistical software, with the level of significance set at p<0.05. The difference in clinical parameters between baseline, and between interventions, will be evaluated using a “Paired t-test”.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2022
Actual
Date of last participant enrolment
Anticipated
29/07/2022
Actual
Date of last data collection
Anticipated
21/10/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20350 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 35112 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 309527 0
Hospital
Name [1] 309527 0
Sydney Dental Hospital
Country [1] 309527 0
Australia
Funding source category [2] 310039 0
Commercial sector/Industry
Name [2] 310039 0
Piksters
Country [2] 310039 0
Australia
Funding source category [3] 310040 0
Commercial sector/Industry
Name [3] 310040 0
WaterPik c/o Church and Dwight Australia PTY LTD
Country [3] 310040 0
Australia
Funding source category [4] 310041 0
Commercial sector/Industry
Name [4] 310041 0
Curaprox Austalia Pty Ltd
Country [4] 310041 0
Australia
Primary sponsor type
Hospital
Name
Sydney Dental Hospital
Address
2 Chalmers Street
Surry Hills
NSW 2010
Country
Australia
Secondary sponsor category [1] 310523 0
University
Name [1] 310523 0
The University of Sydney
Address [1] 310523 0
The University of Sydney,
Camperdown NSW 2006
Country [1] 310523 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309308 0
REGIS Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 309308 0
Ethics committee country [1] 309308 0
Australia
Date submitted for ethics approval [1] 309308 0
20/07/2020
Approval date [1] 309308 0
17/05/2021
Ethics approval number [1] 309308 0
X20-0328 & 2020/ETH01909 9.6/MAY21

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113714 0
Mr Andrew Terry
Address 113714 0
Sydney Dental Hospital
Level 8
2 Chalmers Street
Surry Hills NSW 2010
Country 113714 0
Australia
Phone 113714 0
+61293518337
Fax 113714 0
Email 113714 0
[email protected]
Contact person for public queries
Name 113715 0
Andrew Terry
Address 113715 0
Sydney Dental Hospital
Level 8
2 Chalmers Street
Surry Hills NSW 2010
Country 113715 0
Australia
Phone 113715 0
+61293518337
Fax 113715 0
Email 113715 0
[email protected]
Contact person for scientific queries
Name 113716 0
Andrew Terry
Address 113716 0
Sydney Dental Hospital
Level 8
2 Chalmers Street
Surry Hills NSW 2010
Country 113716 0
Australia
Phone 113716 0
+61293518337
Fax 113716 0
Email 113716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are looking at the cohorts overall percentage reponse to the interventions not at any one individuals data


What supporting documents are/will be available?




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.