Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001047482
Ethics application status
Approved
Date submitted
1/10/2024
Date registered
23/09/2025
Date last updated
23/09/2025
Date data sharing statement initially provided
23/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the influence of photobiomodulation on inflammatory biomarkers in patients with Temporomandibular disorders
Scientific title
Assessing the influence of photobiomodulation on inflammatory biomarkers in adults with Temporomandibular disorders
Secondary ID [1] 312987 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
temporomandibular joint disorder 335166 0
Condition category
Condition code
Musculoskeletal 331661 331661 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be requested to expectorate saliva immediately before photobiomodulation therapy. Patients will chew on a paraffin wax block to stimulate saliva production for 2 minutes. Patients will then be asked to relax and administered photobiomodulation (PBM) treatment using near infared lasers on both sides of their TMJ. After 1 hour, patients will be asked to expectorate saliva once again. After 24 hours of treatment, patients will be requested to expectorate saliva for a final time. The experimental treatments involved in this study will take place at the Griffith University Dental Clinic, Gold Coast Campus and The Thirty Two, T28/129 Queen St, Southport.

The wavelength of the laser is 1064 nm. the power of the laser is 80 W. the power of the laser is 50 J. the pulse frequency is 0.5 to 100 Hz. The duration is 10minutes. A dentist will be administering the treatment.
Intervention code [1] 329521 0
Treatment: Devices
Comparator / control treatment
Sham control patients are not subjected to infared-laser treatment. A beam of red visible light will be aimed at one side of the participant's TMJ to simulate the PBM treatment in Sham treatment
Control group
Placebo

Outcomes
Primary outcome [1] 339387 0
Inflammatory biomarker analysis (TNF-A)
Timepoint [1] 339387 0
Prior, 1hr after and 24 after (primary timepoint) infared laser administration
Primary outcome [2] 342663 0
Inflammatory biomarker analysis (Il-1B)
Timepoint [2] 342663 0
Prior, 1hr after and 24 after (primary timepoint) infared laser administration
Secondary outcome [1] 439730 0
Pain
Timepoint [1] 439730 0
baseline and 24hrs after infared laser application

Eligibility
Key inclusion criteria
Patients that are diagnosed with TMD, are above the age of 18
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with TMD that are using pharmaceutical drugs to treat TMD.

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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer
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
Not yet recruiting
Date of first participant enrolment
Anticipated
25/09/2025
Actual
Date of last participant enrolment
Anticipated
30/11/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 43175 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 317424 0
University
Name [1] 317424 0
Griffith University
Country [1] 317424 0
Australia
Primary sponsor type
University
Name
Griffith Univerisity Faculty of Medicine and Dentistry
Address
Country
Australia
Secondary sponsor category [1] 319717 0
None
Name [1] 319717 0
none
Address [1] 319717 0
Country [1] 319717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316146 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316146 0
Ethics committee country [1] 316146 0
Australia
Date submitted for ethics approval [1] 316146 0
09/08/2024
Approval date [1] 316146 0
08/10/2024
Ethics approval number [1] 316146 0

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

Contacts
Principal investigator
Name 136934 0
Prof Roy George
Address 136934 0
G40 7.67, Griffith University, Parklands Drive, Southport Gold Coast Campus, QLD, 4215
Country 136934 0
Australia
Phone 136934 0
+61 7 56780751
Fax 136934 0
Email 136934 0
[email protected]
Contact person for public queries
Name 136935 0
Roy George
Address 136935 0
G40 7.67, Griffith University, Parklands Drive, Southport Gold Coast Campus, QLD, 4215
Country 136935 0
Australia
Phone 136935 0
+61 7 56780751
Fax 136935 0
Email 136935 0
[email protected]
Contact person for scientific queries
Name 136936 0
Roy George
Address 136936 0
G40 7.67, Griffith University, Parklands Drive, Southport Gold Coast Campus, QLD, 4215
Country 136936 0
Australia
Phone 136936 0
+61 7 56780751
Fax 136936 0
Email 136936 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.