Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000022460
Ethics application status
Approved
Date submitted
18/10/2024
Date registered
15/01/2025
Date last updated
15/01/2025
Date data sharing statement initially provided
15/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of photobiomodulation 808 nm and 660 nm by assessing S100 A8/A9 protein level in pulp blood and gingival crevicular fluid in patients with symptomatic irreversible pulpitis
Scientific title
Effect of photobiomodulation 808 nm and 660 nm by assessing S100 A8/A9 protein level in pulp blood and gingival crevicular fluid in patients with symptomatic irreversible pulpitis
Secondary ID [1] 313217 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
symptomatic irreversible pulpitis 335516 0
Condition category
Condition code
Oral and Gastrointestinal 332076 332076 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

Participants in the intervention group will receive PBM only receive one of either wavelength treatment
A single intervention session last about 1 min , a postgraduate student in the Doctor of Clinical Dentistry program will be administering the intervetion who is a registered dentist
The gingival tissue will not be in the line of irradiation


Photobiomodulation - PBM
The laser irradiation will be performed by placing the optic fibre tip in line with the occlusal access cavity of the tooth with exposed pulp tissue, and the irradiation time will be 60 sec. Gingival tissue will not in the line of irradiation. The power output of two wavelengths has been assessed using a power meter (Ophir Optronics, MKS Instruments Inc, Utah, US). The 808 nm PBM will be administered with a power density of 0.5 W/cm² and an energy density of 30 J/cm². The 660 nm PBM will be applied with a power density of 0.28 W/cm² and an energy density of 16.8 J/cm².
Intervention code [1] 329791 0
Treatment: Devices
Comparator / control treatment
Control group only receive sham irradiation , the laser probe will be placed as same as the intervention group, however the laser will not be activated
Control group
Placebo

Outcomes
Primary outcome [1] 339672 0
Assess Level of S 100 A8/A9 change in pulp blood before and after intervention in comparison to control group
Timepoint [1] 339672 0
S100 A8/A9 protein levels in pulp blood will be quantified using ELISA before and immediate after intervention once all samples all collected
Secondary outcome [1] 441654 0
Assess Level of S 100 A8/A9 change in gingival crevicular fluid before and after intervention in comparison to control group
Timepoint [1] 441654 0
S100 A8/A9 protein levels in gingival fluids before and after intervetion will be quantified using ELISA once all samples collected

Eligibility
Key inclusion criteria
Patients diagnosed with symptomatic irreversible pulpitis from the age range of 18 to 80 years will be included in this study. Patients will be required to describe the pain using a visual analogue scale (1-10), and pain levels will be assessed by the operator using various assessment tools, Patients with a pain score of 7/10 and above were included in this study. The diagnosis of symptomatic irreversible pulpitis (SIP) will follow the American Association of Endodontists (AAE) Glossary of Endodontic Terms
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with periodontal disease, cancer, immunocompromised condition, intake of opioid medication, internal or external root reporting, teeth with a history of trauma, root fracture and teeth with open apices and apical radiolucency were excluded from the study.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Completed
Date of first participant enrolment
Anticipated
Actual
3/04/2023
Date of last participant enrolment
Anticipated
Actual
1/07/2024
Date of last data collection
Anticipated
Actual
1/07/2024
Sample size
Target
42
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 43330 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 317661 0
University
Name [1] 317661 0
Griffith University
Country [1] 317661 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 320129 0
None
Name [1] 320129 0
Address [1] 320129 0
Country [1] 320129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316359 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316359 0
Ethics committee country [1] 316359 0
Australia
Date submitted for ethics approval [1] 316359 0
01/09/2022
Approval date [1] 316359 0
01/10/2022
Ethics approval number [1] 316359 0
2022/670

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

Contacts
Principal investigator
Name 137642 0
Dr Meifang Zhu
Address 137642 0
Griffith University, School of Dentistry and Oral Health , Parkland Drive, Southport, QLD, 4215
Country 137642 0
Australia
Phone 137642 0
+61 413505896
Fax 137642 0
Email 137642 0
[email protected]
Contact person for public queries
Name 137643 0
Meifang Zhu
Address 137643 0
Griffith University, School of Dentistry and Oral Health , Parkland Drive, Southport, QLD, 4215
Country 137643 0
Australia
Phone 137643 0
+61 413505896
Fax 137643 0
Email 137643 0
[email protected]
Contact person for scientific queries
Name 137644 0
Meifang Zhu
Address 137644 0
Griffith University, School of Dentistry and Oral Health , Parkland Drive, Southport, QLD, 4215
Country 137644 0
Australia
Phone 137644 0
+61 413505896
Fax 137644 0
Email 137644 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• sharing to other researchers for the purposes of IPD meta-analysis

Conditions for requesting access:
• -

What individual participant data might be shared?
• results data will be shared

What types of analyses could be done with individual participant data?
• Any purpose, only to achieve to the aims in the approved proposal, for IPD meta-analysis

When can requests for individual participant data be made (start and end dates)?
From:
Available for 2 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• by email principal investigator [email protected]

Are there extra considerations when requesting access to 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.