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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
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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
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Secondary ID [1]
313217
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
symptomatic irreversible pulpitis
335516
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Condition category
Condition code
Oral and Gastrointestinal
332076
332076
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329791
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Treatment: Devices
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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
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Assess Level of S 100 A8/A9 change in pulp blood before and after intervention in comparison to control group
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Assessment method [1]
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Pulp blood sample before and after PBM intervention will be used to quantify by ELISA
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Timepoint [1]
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S100 A8/A9 protein levels in pulp blood will be quantified using ELISA before and immediate after intervention once all samples all collected
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Secondary outcome [1]
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Assess Level of S 100 A8/A9 change in gingival crevicular fluid before and after intervention in comparison to control group
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Assessment method [1]
441654
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Gingival fluid sample before and after PBM intervention will be used to quantify by ELISA
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Timepoint [1]
441654
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S100 A8/A9 protein levels in gingival fluids before and after intervetion will be quantified using ELISA once all samples collected
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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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
3/04/2023
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Date of last participant enrolment
Anticipated
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Actual
1/07/2024
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Date of last data collection
Anticipated
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Actual
1/07/2024
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Sample size
Target
42
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
43330
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4215 - Southport
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Funding & Sponsors
Funding source category [1]
317661
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University
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Name [1]
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Griffith University
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Address [1]
317661
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Griffith University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
320129
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Address [1]
320129
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Country [1]
320129
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316359
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Griffith University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
316359
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01/09/2022
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Approval date [1]
316359
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01/10/2022
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Ethics approval number [1]
316359
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2022/670
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Summary
Brief summary
This study aims to evaluate the efficacy of a non-invasive photobiomodulation diode laser in symptomatic irreversible pulpitis by assessing Inflammatory biomarkers S100 A8/A9 protein in pulp blood (PB) and gingival cervical fluids (GCF) before and after intervention
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Meifang Zhu
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Address
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Griffith University, School of Dentistry and Oral Health , Parkland Drive, Southport, QLD, 4215
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Country
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Australia
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Phone
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+61 413505896
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
137643
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Meifang Zhu
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Address
137643
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Griffith University, School of Dentistry and Oral Health , Parkland Drive, Southport, QLD, 4215
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Country
137643
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Australia
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Phone
137643
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+61 413505896
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Fax
137643
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Email
137643
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[email protected]
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Contact person for scientific queries
Name
137644
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Meifang Zhu
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Address
137644
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Griffith University, School of Dentistry and Oral Health , Parkland Drive, Southport, QLD, 4215
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Country
137644
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Australia
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Phone
137644
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+61 413505896
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Fax
137644
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Email
137644
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[email protected]
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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:
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sharing to other researchers for the purposes of IPD meta-analysis
Conditions for requesting access:
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-
What individual participant data might be shared?
•
results data will be shared
What types of analyses could be done with individual participant data?
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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:
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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.
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