Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001583831
Ethics application status
Approved
Date submitted
11/09/2021
Date registered
19/11/2021
Date last updated
15/08/2023
Date data sharing statement initially provided
19/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of applying teledentistry in Residential Aged Care Facilities on oral health outcomes: a feasibility study
Scientific title
Effect of applying teledentistry in Residential Aged Care Facilities on oral health outcomes: a feasibility study
Secondary ID [1] 305128 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Health 323365 0
oral hygiene 323366 0
Condition category
Condition code
Oral and Gastrointestinal 320935 320935 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 320936 320936 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials to be used
• Mouthwatch intra-oral camera
• QLD Health approved teleconferencing software, Microsoft Teams and hardware (Logitech webcam) set up for telehealth at the residential aged care facilities
• Appropriate oral hygiene products provided e.g. Oral 7 SLS-free toothpaste, dry mouth gel and moisturising mouthwash; Colgate Neutraflour 5000ppm high fluoride toothpaste; Open wide mouthrest to assist in mouth opening during oral hygiene; Surround toothbrush

Procedure
1. Teledentistry consultation. Resident and staff will be paired to complete this part of the study. The examination will be completed through a real time videoconference.
2. Randomised controlled trial (RCT). We want to assess whether teledentistry can be used to give preventive oral health advice and whether this would improve oral hygiene. This would be conducted through an RCT. The groups will be assigned through an online random number generator.
Intervention group: given preventive dental advice through teledentistry only. Appropriate oral hygiene products will be recommended and provided (delivery to RACF prior to the study).
3. In person site visit. The site visit will be in person, at 1 month after the teledentistry consultation. The aim of this part of the study is to compare the data collected from the self-assessment, the teledentistry consultation and the in-person visit.

Who will deliver the intervention
The study would be completed by a dental specialist or specialist in training in special needs dentistry

Mode of delivery
During the study, there will be a few parts: a dental screen questionnaire, discussion about your oral hygiene and health, and a post study evaluation. The whole study will take approximately 1.5 hours to complete. The study is divided in different parts and the longest time for each of these will be around 20mins.

Number of times intervention delivered
• Teledentistry consultation will happen once
• Oral health and hygiene advice will be delivered once at different stages of the study depending on group allocation
• The aim of the study is to identified underlying oral health problems that require further attention. For participants with dental care needs, referral pathways will be established. (see further treatment requirements)

Location where intervention will occur
The study will involve participants in Metro North (Qld Health) aged care services at Cooinda House and Gannet House in Brisbane. A site visit and small focus group meetings have been conducted at both facilities with the Nurse Unit Manager (NUM) and associate NUM at both facilities.

The study will commence online through Microsoft Teams. For ambulant participants, the consultation would occur in the designated room at the RACF with a desktop, a webcam and Mouthwatch intra-oral camera. For non-ambulant participants, this can be accessed via a laptop with a webcam and Mouthwatch intra-oral camera at their bedside.

The in-site portion will be conducted at the respective facilities. Appropriate rooms are available for a clinical exam.

Participant adherence can be monitored through a spreadsheet, with participant ID and task required:
1. Pre-teledentistry screening
2. Teledentistry consultation
3. Oral hygiene advice: teledentistry (intervention) in person (control)
4. In person site visit

Oral hygiene advice
This would be based on the Government of South Australia “Better Oral Health in Residential Care” resources which can be found here:
https://www.sahealth.sa.gov.au/wps/wcm/connect/774e660047d747529e6d9ffc651ee2b2/BOHRC_Staff_Portfolio_Module_2%5B1%5D.pdf?MOD=AJPERES&CACHEID=ROOTWORKSPACE-774e660047d747529e6d9ffc651ee2b2-nKKILB9
This is the training manual for residential aged care staff which outlines protective equipment requirement, oral hygiene aids and products, toothbrushing alternatives, positioning tips and denture cleaning.
Input could also be based on professional opinions from the clinicians conducting the study.

Further treatment requirements
A domiciliary service can be provided for residents, if appropriate. For those who require dental care beyond the scope of a domiciliary service, referral to appropriate dental care providers will be facilitated. Appropriate dental providers could be a private dentist of their choice. For those who are eligible for public dental services, they will be placed on the appropriate waiting list. This would include waiting list at our own specialist Special Needs Dentistry Clinic depending on the case. For residents this would be either private or public pathways. Investigators in this project are all experienced clinicians in both public and private sectors and impartial and appropriate recommendations will be made to ensure that dental needs are managed.
Intervention code [1] 321538 0
Early detection / Screening
Intervention code [2] 321539 0
Prevention
Comparator / control treatment
Control group will receive the teledentistry assessment as per intervention group. No preventive dental advice during teledentistry, however this group will be given structured and tailored preventive dental advice at the one month in person exam. Discussion regarding medical history will be undertaken to make the time equal as the intervention group during teledentistry.

In-person site visit: Participants in the control group will now receive structured and tailored oral health hygiene advice, delivered in the same manner as for the intervention group. Appropriate oral hygiene products will be recommended and provided at this visit. This is to ensure that every participant will receive tailored preventive oral hygiene advice.

Who will deliver the intervention
The study would be completed by a dental specialist or specialist in training in Special Needs Dentistry

Mode of delivery
During the study, there will be a few parts: a dental screen questionnaire, discussion about your oral hygiene and health, and a post study evaluation. The whole study will take approximately 1.5 hours to complete. The study is divided in different parts and the longest time for each of these will be around 20mins.

Number of times intervention delivered
• Teledentistry consultation will happen once
• Oral health and hygiene advice will be delivered once at different stages of the study depending on group allocation

Location where intervention will occur
The study will involve participants in Metro North (Qld Health) aged care services at Cooinda House and Gannet House in Brisbane. A site visit and small focus group meetings have been conducted at both facilities with the Nurse Unit Manager (NUM) and associate NUM at both facilities.

The study will commence online through Microsoft Teams. For ambulant participants, the consultation would occur in the designated room at the RACF with a desktop, a webcam and Mouthwatch intra-oral camera. For non-ambulant participants, this can be accessed via a laptop with a webcam and Mouthwatch intra-oral camera at their bedside.

The in-site portion will be conducted at the respective facilities. Appropriate rooms are available for a clinical exam.

Participant adherence can be monitored through a spreadsheet, with participant ID and task required:
1. Pre-teledentistry screening
2. Teledentistry consultation
3. Oral hygiene advice: in person (control)
4. In person site visit
Control group
Active

Outcomes
Primary outcome [1] 328718 0
Clinician completing the OHAT through teledentistry
Timepoint [1] 328718 0
initial assessment during teledentistry
Primary outcome [2] 328719 0
Oral health assessment by clinician completing in person exam based on an adapted WHO Oral Health Assessment during the 1 month post-teledentistry in person site visit
Timepoint [2] 328719 0
1 month post teledentistry
Primary outcome [3] 329423 0
Effectiveness of oral hygiene and health advice through teledentistry.

This would examine the oral hygiene status of those in the intervention vs control group.
Timepoint [3] 329423 0
initial assessment during teledentistry, 1 month post-teledentistry during in person site visit
Secondary outcome [1] 402723 0
OHAT completed by nurses
Timepoint [1] 402723 0
primary outcome. baseline exam

Eligibility
Key inclusion criteria
• Residents and staff who reside/ work at the residential aged care facility (Cooinda house and Gannet house)
• Those who consent to participate in study, or those who consent through a substitute decision maker
• Those with < 15 PAS score i.e. those who don't have severe cognitive impairment.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Psychogeriatric Assessment Scale (PAS) Score is an annual assessment for residents at the RACF. A score of equal to or greater than 15 would indicate severe cognitive impairment and they would be excluded from the study.

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)
Allocation will be done by a separate investigator from the clinician doing the clinical examinations
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using an online randomiser such as https://www.randomizer.org/. Participants can be split into either the intervention or control group based on their participant number
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis will be completed for the resident’s baseline characteristics based on the demographic, oral health status, and the data from the questionnaire such as dental attendance pattern. This will inform us of changes in attendance pattern upon entering aged care facility, and its effect on oral health.

Data will be analysed using a variety of approaches. However, the key analyses will involve a repeated measures analysis of variance, with OHAT scores and oral cleanliness as the key dependent measures of interest. The primary prediction to be tested will be that, with a 2 (time: baseline, follow-up) x 2 (group: intervention, control), repeated measures ANOVA, a significant interaction effect will emerge, whereby at baseline, groups should be equivalent in their scores on the measure of oral health, but at follow-up, the intervention group should show significantly better levels of oral health across all key indices of this construct taken relative to the control group.

A total sample size of 60 participants, the power in this study to detect the hypothesised large-sized effects between the two groups meets conventionally accepted criteria.

To achieve the aims of the study, the study will be analysed both qualitatively and quantitatively.

The qualitative analysis will be undertaken based on the results of:
1. the background questionnaire
2. the semi-structure interview

The quantitative analysis involves:
1. Comparison of dentist OHAT and in person clinical exam
2. Comparison of dentist and nurse OHAT
3. Comparison of oral cleanliness control vs test group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/12/2021
Actual
6/04/2022
Date of last participant enrolment
Anticipated
22/09/2023
Actual
30/11/2022
Date of last data collection
Anticipated
31/10/2023
Actual
28/02/2023
Sample size
Target
60
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20337 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 35092 0
4029 - Herston
Recruitment postcode(s) [2] 35093 0
4017 - Brighton
Recruitment postcode(s) [3] 35094 0
4021 - Kippa-Ring

Funding & Sponsors
Funding source category [1] 309520 0
University
Name [1] 309520 0
The University of Queensland
Country [1] 309520 0
Australia
Primary sponsor type
Government body
Name
Metro North Oral Health Services
Address
288 Herston Road, Herston, QLD 4006
Country
Australia
Secondary sponsor category [1] 310504 0
None
Name [1] 310504 0
Address [1] 310504 0
Country [1] 310504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309301 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 309301 0
Ethics committee country [1] 309301 0
Australia
Date submitted for ethics approval [1] 309301 0
30/08/2021
Approval date [1] 309301 0
24/11/2021
Ethics approval number [1] 309301 0
HREC/2021/QRBW/77399

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

Contacts
Principal investigator
Name 113686 0
Dr Candy Fung
Address 113686 0
Oral Health Centre
Metro North Oral Health Services
288 Herston Road, Herston QLD 4006
Country 113686 0
Australia
Phone 113686 0
+61404051202
Fax 113686 0
Email 113686 0
candy.fung@health.qld.gov.au
Contact person for public queries
Name 113687 0
Candy Fung
Address 113687 0
Oral Health Centre
Metro North Oral Health Services
288 Herston Road, Herston QLD 4006
Country 113687 0
Australia
Phone 113687 0
+61404051202
Fax 113687 0
Email 113687 0
candy.fung@health.qld.gov.au
Contact person for scientific queries
Name 113688 0
Candy Fung
Address 113688 0
Oral Health Centre
Metro North Oral Health Services
288 Herston Road, Herston QLD 4006
Country 113688 0
Australia
Phone 113688 0
+61404051202
Fax 113688 0
Email 113688 0
candy.fung@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.