Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001143617
Ethics application status
Approved
Date submitted
26/09/2023
Date registered
6/11/2023
Date last updated
6/11/2023
Date data sharing statement initially provided
6/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the proposed effect of low-level laser therapy in providing pain relief in human teeth
Scientific title
A trial evaluating the relative efficacy and tolerability of near infrared and infrared photo biomodulation in inducing dental analgesia among adults with healthy permanent teeth.
Secondary ID [1] 310615 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental analgesia 331600 0
Dental anaesthesia 331742 0
Condition category
Condition code
Anaesthesiology 328336 328336 0 0
Pain management
Oral and Gastrointestinal 328337 328337 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
Intervention used in this study will be laser and Light-emitting diode (LED) therapy, delivered by the Principal Investigator (AHPRA registered general dentist). Participants will be selected based on the appropriateness and health of the selected teeth (premolars). These teeth will be required to have no previous injury, decay, or dental work completed on it. The gum health will also need to be healthy (no bleeding on probing, probing depths less than 3mm, no recession, no exposed root surface) Participants will be required to attend 4 appointments for the four light delivery sources. Each appointment, one light source will be used. The four used are of various wavelengths: 660nm, 808nm, 904nm, and multiwavelength (range of 660-1000nm). These will be delivered to the selected tooth, front (buccal) and back (palatal) for 30 seconds each. There is no washout period, and four sessions can be spaced out according to participant’s convenience. All four sessions will be scheduled prior to starting in the appointment calendar used at site (Oasis, Henry Schein One software). The intervention will delivered face to face within a clinical setting utilising appropriate Personal protective equipment and following manufacturer instructions. Each participant will then be tested for pulpal sensitivity using a commonly used dental equipment called Electric pulp test. The reading will be recorded. Upon this, one laser per session will be used. 4 lasers are: 660nm, 808nm, 904nm, Combined (700nm, 900nm, 1000nm). Each laser is placed next to the tooth, front and back of it, for 30 seconds each, totalling 60 seconds, Upon completion, 2 minutes later, the electric pulp test is used to measure the reading again and this is recorded.
Intervention code [1] 327093 0
Treatment: Other
Comparator / control treatment
Comparator treatment, all four lasers will be compared with each other. Reference comparator is 904nm as it has the most evidence so far.
Control group
Active

Outcomes
Primary outcome [1] 336188 0
Vitality testing - sensibility
Timepoint [1] 336188 0
Post - Photobiomodulation (PBM) with the lasers, electric pulp test measurements are taken at 1 minute mark, 2 minute mark, 5 minute mark, and 20 minute mark.
Secondary outcome [1] 427247 0
Discomfort during procedure with individual PBM sources
Timepoint [1] 427247 0
Immediately post-PBM

Eligibility
Key inclusion criteria
Individuals with healthy non-restored premolars bilaterally.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any teeth deemed to have significant alterations to normal histology as a result of past restorations, current decay or periodontal/endodontic pathologies were excluded. Patients taking immunomodulators or analgesics were excluded. Pregnant patients were excluded.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Split mouth, patient acts as their own control
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
SPSS and Prism 3 are used. Normality testing will be conducted. Repeated measure-ANOVA to be used to compare groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2023
Actual
Date of last participant enrolment
Anticipated
7/12/2023
Actual
Date of last data collection
Anticipated
12/01/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 41417 0
5006 - North Adelaide
Recruitment postcode(s) [2] 41416 0
5343 - Berri

Funding & Sponsors
Funding source category [1] 314832 0
University
Name [1] 314832 0
Griffith University
Country [1] 314832 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Gold Coast campus, Southport, QLD 4215
Country
Australia
Secondary sponsor category [1] 316914 0
None
Name [1] 316914 0
Address [1] 316914 0
Country [1] 316914 0
Other collaborator category [1] 282825 0
Charities/Societies/Foundations
Name [1] 282825 0
Australian Dental Foundation
Address [1] 282825 0
63 Palmer Place, north adelaide 5006 SA
Country [1] 282825 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313834 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 313834 0
G40, Gold coast campus, southport, qld 4215
Ethics committee country [1] 313834 0
Australia
Date submitted for ethics approval [1] 313834 0
01/09/2022
Approval date [1] 313834 0
27/10/2022
Ethics approval number [1] 313834 0
2022/668

Summary
Brief summary
This project will be built upon a recently published systematic review that the project investigators have conducted. This study is being completed as part of Dr Sachin Kulkarni’s Doctor of Philosophy (PhD) program at Griffith University. Purpose of the study:
To determine the efficacy of Photobiomodulation on providing anaesthesia of teeth. Fear of dental aesthetic injection can produce anxiety and contribute to dental phobia. Recently, other methods have been studied for their effectiveness to produce anaesthesia. One such method is known as Photobiomodulation. The purpose of this study is to utilise laser to assess where the sensitivity of the nerve inside the tooth reduces.

Public: The purpose of this study, or hypothesis, is that the laser devices should produce some amount of pain relief as tested with a commonly used dental nerve testing device.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129494 0
Dr Sachin Kulkarni
Address 129494 0
Griffith University, gold coast, southport campus, 4215 QLD
Country 129494 0
Australia
Phone 129494 0
+61 430218069
Fax 129494 0
Email 129494 0
sachin.kulkarni@griffithuni.edu.au
Contact person for public queries
Name 129495 0
Dr Sachin Kulkarni
Address 129495 0
Griffith University, gold coast, southport campus, 4215 QLD
Country 129495 0
Australia
Phone 129495 0
+61 430218069
Fax 129495 0
Email 129495 0
sachin.kulkarni@griffithuni.edu.au
Contact person for scientific queries
Name 129496 0
Dr Sachin Kulkarni
Address 129496 0
Griffith University, gold coast, southport campus, 4215 QLD
Country 129496 0
Australia
Phone 129496 0
+61 430218069
Fax 129496 0
Email 129496 0
sachin.kulkarni@griffithuni.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20487Ethical approval    386609-(Uploaded-26-09-2023-16-55-08)-Study-related document.pdf
20488Informed consent form    386609-(Uploaded-26-09-2023-16-55-01)-Study-related document.docx



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.