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Trial registered on ANZCTR


Registration number
ACTRN12623000449639
Ethics application status
Approved
Date submitted
12/04/2023
Date registered
2/05/2023
Date last updated
17/04/2024
Date data sharing statement initially provided
2/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Toothbrushing instruction and mouth health educational videos targeting patients within cardiac rehabilitation clinics.
Scientific title
Effect of oral hygiene instruction and digital oral health education within cardiac rehabilitation clinics, a randomised controlled trial.
Secondary ID [1] 309437 0
Nil known
Universal Trial Number (UTN)
U1111-1291-1744
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 329690 0
Periodontal disease 329691 0
Condition category
Condition code
Cardiovascular 326588 326588 0 0
Coronary heart disease
Oral and Gastrointestinal 326589 326589 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 randomised into one of 3 arms as follows:

Group A) Individualised oral hygiene instruction (OHI) partnered with an oral health education video package,
Group B) oral health education video package only,
Group C) Control arm consisting of usual care within the cardiac rehabilitation clinic (no oral health education).

Oral hygiene instruction will be delivered using results from the clinical assessment as a guide for patient focus by a trained research assistant and/or dental/oral health students at baseline and the 6 week follow up. The advice will take no longer than 10 mins and will be reinforced by the outcome assessor (qualified oral health therapist) at the 12-week follow up. Toothbrushing or interdental cleaning instructions will be given in accordance with the oral hygiene standard operating procedure (SOP) designed specifically for the study. Oral health clinical measurements taken at each visit should show if the patient has changed their habits as per the advice, and if they are continuing to use these throughout the study.

Oral health education video package will include videos that are advertisement free; and created by either government bodies, or relevant health bodies such as the Australian Dental Association (ADA). They will contain content related to oral health and cardiovascular health, and if randomised into Group A or Group B, the same videos will be repeated at each visit. This will again be monitored for change via oral health clinical measurements at each visit. The video package will contain approximately 4-6 videos which are between 1-2 minutes of duration each.

At the final follow up (12-weeks), after completing clinical measurements and the follow-up questionnaire, Group B and Group C will be given tailored OHI. Group C will also be shown the video package.
Intervention code [1] 325864 0
Prevention
Comparator / control treatment
Participants in the control arm: Group C will receive usual care from the cardiac rehabilitation clinic which includes education on diet, fitness and other cardiovascular disease risk factors, however does not include oral health/toothbrushing. Participants in Group C will receive oral health education at the final follow-up appointment.
Control group
Active

Outcomes
Primary outcome [1] 334443 0
The primary outcome of this study is to show a change in approximal plaque index (API) score between baseline and the 6-week follow up
Timepoint [1] 334443 0
Baseline and 6-weeks after inital/baseline assessment.
Secondary outcome [1] 420674 0
To show a change in API score between baseline and the 12-week follow up
Timepoint [1] 420674 0
Baseline and 12 week follow-up from the base line assessment.
Secondary outcome [2] 420676 0
Compare changes in API mean scores after 6 and 12 weeks, compared to baseline, between each group.
Timepoint [2] 420676 0
Baseline, 6- and 12-week from baseline assessment.
Secondary outcome [3] 420678 0
Change in oral hygiene habits using a Likert Scale
Timepoint [3] 420678 0
6- and 12-weeks post- commencement of intervention
Secondary outcome [4] 420679 0
Change in understanding between the link between heart health and oral health using a Likert Scale
Timepoint [4] 420679 0
6- and 12-weeks post- commencement of intervention
Secondary outcome [5] 420680 0
Cardiac nurse perception of the importance of the intervention using a Likert scale.
Timepoint [5] 420680 0
After study conclusion
Secondary outcome [6] 420934 0
Cardiac nurse perception of the effectiveness of the intervention using a Likert scale.
Timepoint [6] 420934 0
After study conclusion
Secondary outcome [7] 420935 0
Change in confidence to improve oral hygiene habits using a Likert scale
Timepoint [7] 420935 0
6- and 12-weeks post- commencement of intervention
Secondary outcome [8] 420936 0
Change in motivation to improve their oral health using a Likert scale.
Timepoint [8] 420936 0
6- and 12-weeks post- commencement of intervention
Secondary outcome [9] 421318 0
Compare changes in sulcus bleeding index mean scores after 6 and 12 weeks, compared to baseline, between each group.
Timepoint [9] 421318 0
6- and 12 weeks follow-up from the base line assessment.
Secondary outcome [10] 421319 0
Change in motivation to see an oral health practitioner (OHP) regularly using a Likert scale.
Timepoint [10] 421319 0
6- and 12-weeks post- commencement of intervention

Eligibility
Key inclusion criteria
- Equal to or greater than 18 years old with a recent cardiovascular disease event
- Recent myocardial infarction and/or recent hospitalisation resulting from cardiovascular disease
- Greater than or equal to 60% API Score
- Speaks English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- they have been diagnosed with heart failure.
- have/are waiting for a heart transplant,
- are too physically or mentally unwell on the day.
- have a cognitive impairment and are attending without a carer.
- who do not speak or have limited language skills in English.
If they have visited an OHP for treatment of gum disease (supra- and/or subgingival scaling and root planning) in the last 6 months,
- have an API score of less than or equal to 59%
- are edentulous.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The required sample size for this study is calculated to be a total of 165 (1:1:1 Group A: Group B: Group C). This calculation includes provision for a 10% attrition rate, two tailed tests, type 1 error of 5%, and will have 80% power to detect any significant difference between Group A and Group C. This calculation is based from an API score reduction of 25% in the intervention arm of Ziebolz, et al 2009 study. However, due to our exclusion criteria of less than or equal to 59% API score, we will expect to see a 40% decrease in Group A, compared to 15% in Group C. This current study is powered to detect a difference in percentage proportion of those between Group A and Group C however, has poor power to detect a difference between Group B and Group C.

The statistical plan for this study will be determined prior to study completion. Analysis of the difference in API will be according to the intention-to-treat principle where participants are analysed in the arm they have been allocated. The level of statistical significance will be set at p-value <0.05. The primary analysis will be an adjusted analysis of variance performed to assess differences between groups for API scores between baseline and follow-up. Covariates used for adjusted analyses will include age, sex, highest PSR code, level of education, smoking status, and number of teeth. Subgroup analysis of the intervention effect and age, sex, education, ethnicity, and cardiovascular disease presentation (coronary heart disease, heart failure, heart transplant list, heart transplant receiver) will also be explored. Outcome measures available at baseline (PSR, SBI and API) will also be included in the statistical model. An unadjusted analysis will be performed to assess differences between groups using a X2 test for binary (categorical) outcomes and independent sample t-tests for continuous outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/08/2023
Actual
22/08/2023
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
9/01/2025
Actual
Sample size
Target
165
Accrual to date
56
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24500 0
Westmead Hospital - Westmead
Recruitment hospital [2] 24501 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 40089 0
2145 - Westmead
Recruitment postcode(s) [2] 40090 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 313633 0
University
Name [1] 313633 0
The University of Sydney
Country [1] 313633 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Cnr Hawkesbury Road and, Darcy Rd,
Westmead NSW 2145.
Country
Australia
Secondary sponsor category [1] 315426 0
None
Name [1] 315426 0
Address [1] 315426 0
Country [1] 315426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312803 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312803 0
Ethics committee country [1] 312803 0
Australia
Date submitted for ethics approval [1] 312803 0
14/03/2023
Approval date [1] 312803 0
14/06/2023
Ethics approval number [1] 312803 0

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

Contacts
Principal investigator
Name 125978 0
Prof Clara Chow
Address 125978 0
Westmead Hospital
Level 5
Block K - Entrance 10,
Hawkesbury Road Westmead, NSW, 2145
Country 125978 0
Australia
Phone 125978 0
+61286273580
Fax 125978 0
Email 125978 0
[email protected]
Contact person for public queries
Name 125979 0
Shalinie King
Address 125979 0
Westmead Hospital
Level 5
Block K - Entrance 10,
Hawkesbury Road Westmead, NSW, 2145
Country 125979 0
Australia
Phone 125979 0
+61402166671
Fax 125979 0
Email 125979 0
[email protected]
Contact person for scientific queries
Name 125980 0
Axel Spahr
Address 125980 0
The University of Sydney School of Dentistry
Sydney Dental Hospital
2 Chalmers St.
Surry Hills NSW 2010
Country 125980 0
Australia
Phone 125980 0
+61292933274
Fax 125980 0
Email 125980 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices) will be made available. Other documents that will be available include the study protocol and statistical analysis plan.
When will data be available (start and end dates)?
The data will be available beginning 9 months and ending 5 years after article publication.
Available to whom?
To researchers who provide a methodologically sound proposal to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve the aims stated in the approved proposal.
How or where can data be obtained?
Proposals should be directed to the lead researcher ([email protected]). To gain access, data requestors will need to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18845Study protocol  [email protected]
18846Statistical analysis plan  [email protected]



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.