Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000922572
Ethics application status
Approved
Date submitted
9/07/2024
Date registered
30/07/2024
Date last updated
30/07/2024
Date data sharing statement initially provided
30/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the Guiding Lifelong Oral Health Wellness Program for mental health consumers.
Scientific title
Evaluating the Impact of the Guiding Lifelong Oral Health Wellness Program on Oral Health Behaviours in Mental Health Consumers
Secondary ID [1] 312438 0
Nil
Universal Trial Number (UTN)
Trial acronym
GLOW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Health 334260 0
Mental Health 334261 0
Condition category
Condition code
Oral and Gastrointestinal 330923 330923 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 331062 331062 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GLOW: Guiding Lifelong Oral Health Wellness
The intervention includes
1. Group oral health education –
o Content overview
• Understanding the connection between oral health and overall systemic health
• Exploring how oral health can impact diseases such as diabetes, cardiovascular diseases and respiratory conditions
• Discussing the etiology and progression of dental caries and periodontal disease, and preventive measures to avoid these common oral health issues
• Demonstrating proper techniques for brushing, flossing and cleaning dentures
• Summarising by discussing the importance of dental check-ups for early detection and treatment of dental problems
o Education Delivery
• An oral health professional will lead the session using engaging PowerPoint presentations and informative video links
• The session will accommodate up to 10 consumers, ensuring a conducive learning environment
• Duration: Approximately 45 minutes
o Strategies for attendance:
• Schedule sessions at convenient times for participants
• Sending reminders via nursing staff either via text messages or phone calls on the day before the session
• Offer small incentives, such as oral hygiene kits to encourage participation
• Collaborate with mental health professionals to promote the sessions and emphasize the importance of oral health

2. Oral health assessment and advice
o Assessment (will be conducted by Oral Health Therapists)
• The validated Oral Health Assessment Tool (OHAT) is used to evaluate the lips, tongue, gums and oral tissues, saliva, natural teeth, dentures, oral cleanliness and dental pain. The assessment takes approximately 10 minutes.
o Plaque Disclosure ( will be conducted by Oral Health Therapists)
• A tri-Plaque ID gel is applied to disclose the level of plaque on participants' teeth, following the Silness and Loe Index
o Personal Advice (will be provided by Oral Health Therapists)
• Based on the assessment results and plaque disclosure, tailored advice will be provided to participants

3. The GLOW program (commences after the education and oral health assessment)
o Plaque Disclosing provider:
• The Tri-Plaque ID gel will be provided by the Oral Health Services
o Toothbrushing and Flossing Demonstration
• Demonstration will be performed using a hands-on approach where professionals will provide step-by-step instructions and assist participants in brushing their teeth using in-mouth demonstration and flossing during the session, offering guidance on correct techniques.
o Nightly reminders for oral care
• A nightly reminder will be provided through mental health clinicians on the wards each evening. Clinicians will deliver the reminder during their routine medication rounds, which occur after dinner. This reminder will encourage participants to complete their oral care routine. The clinicians will also keep a record of whether participants complete their oral care routine each night. This record will be used to monitor the establishment of a routine.
o Mode of review at weeks 4 and 8
• Reviews at week 4 and week 8 will be conducted in person. An oral health professional will visit the wards to perform follow-up assessment, disclosing and reinforce brushing
o Strategies for assessing and monitoring adherence
• Records from mental health clinicians – mental health clinicians will keep a nightly record of whether participants complete their oral care routine – to track daily adherence to oral care routine and provide support
• Review during weeks 4 and 8 – At weeks 4 and 8, follow-up reviews will be conducted. During these reviews, the oral care routine will be discussed with participants, and they will be encouraged to continue their oral care practices – to evaluate progress and reinforce the importance of maintaining the oral care routine
• Readiness for Oral Health Routine (ROHR) questionnaire – participants will complete the ROHR questionnaire to evaluate their motivation and competency in maintaining their oral care routine – to gauge participants’ motivation and readiness for the oral health routine
• Progress tracking: Plaque levels will be assessed using disclosing gel during 4 and 8-week reviews – to monitor changes in oral hygiene, track adherence to recommended practices and evaluate the effectiveness of the oral care routine.
4. Study Design
o Non-randomised study
• In this non-randomised study, group allocation is determined by the clinical setting. Participants at the mental health hospital are allocated to the intervention group. Participants with mental health conditions living independently in the communities are assigned to the comparison group. This approach is used to evaluate the program's effectiveness.
5. Focus group (mental health consumers)
o Aim – explore participants’ perceived facilitators and challenges in establishing a regular oral hygiene routine
o Participants – intervention group and comparison group. Participation is voluntary – individuals will be invited to join based on their interest and willingness to share their experience
o Facilitators – the focus groups will be conducted by an experienced member of the research team
o Size of each group – each focus group will consist of 6-8 participants to have 2-3 focus groups.
o Selection process – participants will be informed about the focus group during the 8th-week review. Those interested will be selected based on voluntary participation. Information including the purpose of the focus group, format and time commitment (45 minutes) will be provided to potential participants.
o Focus group interview – It explores mental health consumers’ experiences and perceptions regarding in-mouth toothbrushing demonstrations and nightly reminders as part of an oral health intervention. It aims to understand how these components influenced their toothbrushing techniques, confidence, routine adherence and overall well-being, while so identify additional strategies and external factors impacting their oral health practices





Intervention code [1] 328941 0
Prevention
Intervention code [2] 328942 0
Rehabilitation
Intervention code [3] 328943 0
Behaviour
Comparator / control treatment
To evaluate the effectiveness of the intervention, a comparator group will be included in the study. This group will receive the same oral health education in group sessions and personalised oral health assessments with tailored advice. They will also receive a plaque-disclosing procedure to motivate them to brush regularly. They will be shown toothbrushing and flossing techniques using a model rather than receiving in-mouth demonstrations. Additionally, the comparator group will not receive nightly reminders from mental health clinicians. Like the intervention group, they will be advised to brush their teeth twice a day with fluoride toothpaste, focusing on bedtime and one additional time during the day. Oral hygiene progress for the compactor group will also be reviewed at four and eight weeks to assess for changes and the establishment of a regular oral hygiene regime. This setup with help determine the added value of in-mouth demonstrations and nightly reminders in improving health outcomes.
Control group
Active

Outcomes
Primary outcome [1] 338687 0
Changes in oral hygiene practice behaviour
Timepoint [1] 338687 0
Baseline - before intervention
4th Week - to assess the establishment of an oral care routine during intervention using the oral care record maintained by the mental health clinicians
8th Week - to assess the establishment of an oral care routine at the end of intervention using the oral care record maintained by mental health clinicians
Secondary outcome [1] 437025 0
To measure changes in plaque index as an indicator of oral hygiene
Timepoint [1] 437025 0
Baseline - initial assessment of plaque index before intervention
4th Week - reassess the changes in plaque index during intervention
8th Week - reassess the changes in plaque index at the end of intervention
Secondary outcome [2] 437026 0
Changes in oral health knowledge
Timepoint [2] 437026 0
Baseline- to assess initial oral health knowledge before the start of the intervention
4th Week - reassess changes in oral health knowledge after 4 weeks of the intervention
8th Week - reassess changes in oral health knowledge to evaluate the longer-term impact at end of intervention
Secondary outcome [3] 437027 0
Factors influencing motivation and confidence levels in establishing a regular oral hygiene regime as a composite secondary outcome
Timepoint [3] 437027 0
Questionnaire -
Baseline - complete ROHR questionnaire before the intervention
4 weeks - re-complete the ROHR questionnaire to assess changes in readiness and motivation after 4 weeks of intervention
8 weeks - complete the ROHR questionnaire for the final assessment of readiness and motivation at the end of the intervention.
Focus Group - Participate in focus group interviews after the intervention period (8 weeks)

Eligibility
Key inclusion criteria
• Aged 18 years and over
• Diagnosed with a mental health condition
• Either receiving mental health care in a hospital or community-based mental health care (living independently in the community)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with mental health conditions who are acutely unwell that impact their ability to engage in study activities. However, due to the fluctuations in the conditions which are usually temporary or episodic; an attempt would be made to seek consent at a time when the condition improves (NHRME4.5.6)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
The primary objective of the study is to evaluate the effectiveness of the comprehensive oral health intervention by assessing the oral health status using the Oral Health Assessment Tool (OHAT). The oral health pre-and post-survey includes oral health knowledge, oral hygiene habits, Self-regulation (SRQ) and Perceived Competence Scale (PCS).
The sample size determination was based on the parameter estimation of the mean. Specifically, the power analysis is based on the method suggested by Kupper and Hafner (1989) which incorporates unknown standard deviation in the sample size determination. The sample size analysis indicated that, if the population size is 120, for a two-sided 95% confidence interval (or 90% power) of mean DMFT/Plaque Index with a margin of error of 1.0, and a 0.09 probability of achieving the target confidence width for an assumed standard deviation of 2, a minimum sample of 49 subjects are required. This sample of 49 subjects is adequate to detect a weak to moderate (r<=0.35) between DMFT/Plaque Index and other variables. Adjusting a non-participation rate of 20%, a total of 59 (or approximately equal to ˜ 60) subjects will be included in the study. Since the sample size is greater than or equal to 30, the criteria of the central limit theorem in terms of normality of the distribution of the means will not get violated in conducting the quantitative analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2024
Actual
Date of last participant enrolment
Anticipated
14/04/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316856 0
Government body
Name [1] 316856 0
Oral Health Services, Primary and Community Health, NSLHD, NSW Health
Country [1] 316856 0
Australia
Primary sponsor type
Government body
Name
Oral Health Services, Northern Sydney Local Health District, NSW Health
Address
Country
Australia
Secondary sponsor category [1] 319091 0
Government body
Name [1] 319091 0
Drug and Alcohol Mental Health Service, Northern Sydney Local Health District, NSW Health
Address [1] 319091 0
Country [1] 319091 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315615 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315615 0
Ethics committee country [1] 315615 0
Australia
Date submitted for ethics approval [1] 315615 0
28/04/2024
Approval date [1] 315615 0
03/06/2024
Ethics approval number [1] 315615 0

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

Contacts
Principal investigator
Name 135262 0
Dr Grace Wong
Address 135262 0
Oral Health Executive Unit, Level 1, Wallace Wurth Building, Macquarie Hospital, Wicks Road, North Ryde, NSW 2113
Country 135262 0
Australia
Phone 135262 0
+61 492 499 016
Fax 135262 0
Email 135262 0
[email protected]
Contact person for public queries
Name 135263 0
Grace Wong
Address 135263 0
Oral Health Executive Unit, Level 1, Wallace Wurth Building, Macquarie Hospital, Wicks Road, North Ryde, NSW 2113
Country 135263 0
Australia
Phone 135263 0
+61 492 499 016
Fax 135263 0
Email 135263 0
[email protected]
Contact person for scientific queries
Name 135264 0
Grace Wong
Address 135264 0
Oral Health Executive Unit, Level 1, Wallace Wurth Building, Macquarie Hospital, Wicks Road, North Ryde, NSW 2113
Country 135264 0
Australia
Phone 135264 0
+61 492 499 016
Fax 135264 0
Email 135264 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


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.