Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623001287628
Ethics application status
Approved
Date submitted
14/11/2023
Date registered
11/12/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
11/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of hearing protective devices in the clinical dental setting
Scientific title
Use of hearing protective devices in the clinical dental setting: a pilot study
Secondary ID [1] 310963 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing loss (occupational noise induced; ONIHL) 332048 0
Condition category
Condition code
Ear 328772 328772 0 0
Other ear disorders
Public Health 328911 328911 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with hearing protection devices in the form of custom-made earplugs for wear in the clinical dental setting.
The devices are manufactured and provided by Pacific Ears, branded 'PACS Pro31 earplugs'. These devices are high-noise filtering and provide attenuation (reduction of amplitude) in loud environments. The devices are designated 'Class 5 hearing protection' per AS/NZS-1270. They are constructed of medical-grade silicone,
The participants will be asked (not required) to wear the devices 'as much as desired' during usual dental clinical activities for a period of twelve weeks..
Assessment of the use of the devices will be by way of periodic questionnaires to be completed online by the participants.
Intervention code [1] 327394 0
Treatment: Devices
Intervention code [2] 327509 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336580 0
Participant experiences
Timepoint [1] 336580 0
Questionnaire: 0, 1, 2, 4, 8 and 12 weeks from beginning.
Focus Group: As soon as possible after week 12.
Secondary outcome [1] 428855 0
Perceptions of use.
Timepoint [1] 428855 0
Questionnaire: 0, 1, 2, 4, 8 and 12 weeks from beginning.
Focus Group: As soon as possible after week 12.

Eligibility
Key inclusion criteria
Dental practitioner
Current clinical practice
Minimum age
23 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No ear condition(s) precluding wear of the device.
Previous wear of such devices

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
29/02/2024
Actual
21/03/2024
Date of last participant enrolment
Anticipated
1/04/2024
Actual
20/05/2024
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315220 0
University
Name [1] 315220 0
The University of Melbourne
Country [1] 315220 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville, Vic, 3010
Country
Australia
Secondary sponsor category [1] 317253 0
None
Name [1] 317253 0
Address [1] 317253 0
Country [1] 317253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314145 0
Human Research Ethics Committee, University of Melbourne
Ethics committee address [1] 314145 0
Ethics committee country [1] 314145 0
Australia
Date submitted for ethics approval [1] 314145 0
04/11/2023
Approval date [1] 314145 0
20/12/2023
Ethics approval number [1] 314145 0
ID 28344

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

Contacts
Principal investigator
Name 130574 0
A/Prof George Alexander
Address 130574 0
Melbourne Dental School, 720 Swanston Street, Carlton, Vic. 3010
Country 130574 0
Australia
Phone 130574 0
+61 3 8344 5304
Fax 130574 0
Email 130574 0
[email protected]
Contact person for public queries
Name 130575 0
George Alexander
Address 130575 0
Melbourne Dental School, 720 Swanston Street, Carlton, Vic. 3010
Country 130575 0
Australia
Phone 130575 0
+61 3 8344 5304
Fax 130575 0
Email 130575 0
[email protected]
Contact person for scientific queries
Name 130576 0
George Alexander
Address 130576 0
Melbourne Dental School, 720 Swanston Street, Carlton, Vic. 3010
Country 130576 0
Australia
Phone 130576 0
+61 3 8344 5304
Fax 130576 0
Email 130576 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
This is a limited pilot study from which data will not be useful for other or future trials. It is designed merely as a means of development of a tool for future (larger) study. Participants will be recruited with such in mind.


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.