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Trial registered on ANZCTR


Registration number
ACTRN12625000200482
Ethics application status
Approved
Date submitted
23/12/2024
Date registered
20/02/2025
Date last updated
20/02/2025
Date data sharing statement initially provided
20/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the effectiveness of Hospital-Based Manufactured Medical Device Restorabite for treatment of Trismus in adults after head and neck cancer surgery (Cohort 2)
Scientific title
Efficacy of Hospital-Based Manufactured Medical Device Restorabite for treatment of Trismus in adults after head and neck cancer surgery (Cohort 2).
Secondary ID [1] 313588 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is a sub-study of ACTRN12621000585820

Health condition
Health condition(s) or problem(s) studied:
Trismus 336117 0
Head and Neck Cancer 336118 0
Condition category
Condition code
Cancer 332669 332669 0 0
Head and neck
Musculoskeletal 332670 332670 0 0
Other muscular and skeletal disorders
Oral and Gastrointestinal 332671 332671 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
The primary objective is to determine optimal exercise duration and force to treat Trismus.

Description of Interventions:
• Passive jaw range of motion exercises using Restorabite as per randomised Arm
• Active jaw range of motion exercises using Restorabite as per randomised Arm
• 10 x 1hr weekly sessions face to face or over telehealth with speech pathology. Gradual progression through the force hierarchy as clinically indicated.
• Home practice: daily for 20 minutes for duration of study (10 weeks)

Passive and active jaw range of motion exercises is a continuous exercise performed with Restorabite. It involves inserting the pressed down Restorabite between the front teeth and letting the device stretch the jaw (passive motion exercise) then bite down on the mouth guards (active motion exercise). Then repeat the letting go of the bite (passive motion exercise) and biting down on the device (active motion exercise).

Participants will be given a Restorabite device and randomised to one of seven daily exercise programs (20 minutes daily).
Arm 1. Low force for maximum of 30 seconds of 4 repetitions x 5 times with Restorabite
Arm 2. Low force for maximum of 60 seconds of 2 repetitions x 5 times with Restorabite
Arm 3. Low force for maximum of 120 seconds of 1 repetition x 5 times with Restorabite
Arm 4. High force for maximum of 30 seconds of 4 repetitions x 5 times with Restorabite
Arm 5. High force for maximum of 60 seconds of 2 repetitions x 5 times with Restorabite
Arm 6. High force for maximum of 120 seconds of 1 repetition x 5 times with Restorabite
Control. Stacked tongue depressor for maximum of 30 seconds of 5 repetitions x 5 times

Low force is defined as maximum intensity of up to 30N (insert position 4 on Restorabite device)
High force is defined as maximum intensity of up to 50N (insert position 8 on Restorabite device)

Participants will be given a device, and the treatment will last for 10 weeks. Participants will be asked to attend 10 sessions of 1-hour weekly appointments with the speech pathologist. These appointments can be conducted either in person or via Telehealth.

Follow up appointments will be required at 6 months and 12 months after the study treatment finishes.

At the first and last appointments and 6 months and 12 months follow up appointments, participants will be asked to answer Quality of Life (QoL) questionnaires.

Optional semi-structured interviews, using an interview guide, will be conducted with patients to evaluate their experiences using a device for trismus at the end of the intervention. These 30-60minute interviews will be conducted via video conferencing (Zoom) once during the course of the trial.

To monitor adherence to the intervention speech pathologists will closely follow up participants. To increase the adherence to the intervention, speech pathologists will set up a 10-week appointment plan at the beginning of the trial and also offer tele-health appointments.
Intervention code [1] 330183 0
Treatment: Devices
Comparator / control treatment
Standard care as control. Standard of care of trismus includes other common devices such as Ark-J (wooden tongue depressor) Theraband or Therabite.

Note: This intervention does not differ from the standard of care of trismus, the novel part of this intervention is the use of Restorabite (with defined duration and force) instead of other devices such as Ark-J.

Home practice: daily for 20 minutes for duration of study (10 weeks)
10 x sessions of 1-hour weekly appointments with the speech pathologist. These appointments can be conducted either in person or via Telehealth.
Control group
Active

Outcomes
Primary outcome [1] 340191 0
Change in interincisal distance (IID)
Timepoint [1] 340191 0
Baseline, end of 10 X weekly sessions, 6 and 12 months follow up.
Secondary outcome [1] 443226 0
Change in patient quality of life
Timepoint [1] 443226 0
Baseline, end of 10 x weekly sessions, 6 and 12 months follow up
Secondary outcome [2] 443227 0
Change in patient quality of life
Timepoint [2] 443227 0
Baseline, end of 10 x weekly sessions, 6 and 12 months follow up
Secondary outcome [3] 443228 0
Change in patient quality of life
Timepoint [3] 443228 0
Baseline, end of 10 x weekly sessions, 6 and 12 months follow up
Secondary outcome [4] 443230 0
Changes in patient quality of life
Timepoint [4] 443230 0
Baseline, end of 10 x weekly sessions, 6 and 12 months
Secondary outcome [5] 444594 0
Changes in patient quality of life
Timepoint [5] 444594 0
Baseline, end of 10 x weekly sessions, 6 and 12 months follow up

Eligibility
Key inclusion criteria
• 18 years and older
• Diagnosis of head and neck cancer (HNC)
• Patients with an interincisal distance (IID) of 35mm or less
• Willingness to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients where trismus therapy is contraindicated due to medical/surgical parameters, guided by their managing physician.

Study design
Purpose of the study
Treatment
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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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 maximum sample size of 280 (7 arms with 20 participants at stage 1 and 7 arms with 20 participants at stage 2) is based on a minimal detectable difference of 5 mm increase in IID, baseline mean IID of 20 mm, standard deviation 6 mm, Family-wide error rate (FWER) 0.05, power 80%, and 20% dropout rate. If futility is demonstrated at interim analysis with no dropouts, the sample size required is 112 participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/04/2023
Date of last participant enrolment
Anticipated
8/06/2025
Actual
Date of last data collection
Anticipated
9/06/2026
Actual
Sample size
Target
280
Accrual to date
146
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 27434 0
Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 27435 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 27436 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 27437 0
Westmead Private Hospital - Westmead
Recruitment hospital [5] 27438 0
Wollongong Hospital - Wollongong
Recruitment hospital [6] 27439 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 43546 0
2050 - Camperdown
Recruitment postcode(s) [2] 43547 0
3000 - Melbourne
Recruitment postcode(s) [3] 43548 0
3050 - Parkville
Recruitment postcode(s) [4] 43549 0
2145 - Westmead
Recruitment postcode(s) [5] 43550 0
2500 - Wollongong
Recruitment postcode(s) [6] 43551 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 318056 0
Hospital
Name [1] 318056 0
Chris O'Brien Lifehouse
Country [1] 318056 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 320435 0
None
Name [1] 320435 0
Address [1] 320435 0
Country [1] 320435 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316707 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 316707 0
https://svhs.org.au/home/research-education/research-office
Ethics committee country [1] 316707 0
Australia
Date submitted for ethics approval [1] 316707 0
23/04/2021
Approval date [1] 316707 0
09/06/2021
Ethics approval number [1] 316707 0
2021/ETH00758

Summary
Brief summary
This study aims to assess the efficacy of a "Restorabite" device to treat a disorder called trismus in head and neck cancer patients.

Who is it for?
You may be eligible for this study if you are an adult with, or who has had in the past, head and neck cancer, and has trouble opening your jaw wider than 35mm.

Study details
Patients will attend 10 x 1 hour weekly sessions with a speech pathologist, where they will be taken through passive and active jaw range of motion exercises. They will also be instructed to complete 20 minutes of home practice daily over the 10-week study period. Data on changes in jaw opening distance and quality of life will be collected.

It is hoped that findings in this study help researchers determine optimal stretching regime for trismus treatment.

Participation in this clinical trial is voluntary.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138738 0
Prof Jonathan Clark
Address 138738 0
Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 138738 0
Australia
Phone 138738 0
+61 2 8514 0268
Fax 138738 0
Email 138738 0
[email protected]
Contact person for public queries
Name 138739 0
Masako Dunn
Address 138739 0
Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 138739 0
Australia
Phone 138739 0
+61 2 8514 0411
Fax 138739 0
Email 138739 0
[email protected]
Contact person for scientific queries
Name 138740 0
Jonathan Clark
Address 138740 0
Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 138740 0
Australia
Phone 138740 0
+61 2 8514 0268
Fax 138740 0
Email 138740 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?

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.