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Trial registered on ANZCTR


Registration number
ACTRN12624001089527p
Ethics application status
Submitted, not yet approved
Date submitted
24/08/2024
Date registered
10/09/2024
Date last updated
10/09/2024
Date data sharing statement initially provided
10/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating Red Light Therapy to Reverse numbness from Dental Injections
Scientific title
A trial exploring the reversal of numbness after dental local anaesthetic injections using LED photobiomodulation in adult and child dental patients.
Secondary ID [1] 312583 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental analgesia 334679 0
Dental anaesthesia 334680 0
Condition category
Condition code
Anaesthesiology 331251 331251 0 0
Anaesthetics
Oral and Gastrointestinal 331252 331252 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
Objective: Compare reversal of numbness following photobiomodulation (PBM) with a multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) to sham exposure.

Intervention: Participant blinded treatment at the end of a dental visit where a local anaestetic injection has been made as part of the normal procedure, using either sham irradiation or actual light exposure with the Nuralyte® (Dentroid Canberra, Australia) - Light-emitting diode (LED) device. This emits light from 700-1100 nm, and has a spot size of 7 mm. This will be used to treat the area of the injection on the mucosa - 4 adjacent spots with 15 secs each (4 J/cm2), with the device held 2 mm away from the soft tissues. It will be applied as a once off for a total of 60 seconds. The recovery to normal as numbness reduces over time will be assessed using standard measures and recorded in a post-operative diary. Details of the type and volume of anaesthetic agent used will be recorded.

Who will deliver the intervention
This trial will be undertaken by a registered general dentist or dental specialist. The intervention will administered in a clinical setting utilising appropriate personal protective equipment and following manufacturer instructions.

Location where intervention will occur
The study will occur at private practice dental clinics in Queensland, Australia (multi-centre study).

Participant selection
Adult dental patients (aged 18 years and above) and child dental patients (aged 6-17 years) who require a dental injection as part of routine dental treatment will be invited to participate in the study. The registered dental practitioner or registered dental specialist will screen the patient and those who adhere to the inclusion criteria will be invited to participate.

Mode of delivery/number of times delivered
Each participant will be randomly selected to receive application of either sham exposure or the Nuralyte® device after completion of dental treatment which required local anaesthesia.

Afterwards, participants will be asked to report on the level of numbness every 15 minutes until complete resolution with a post operative diary.
Intervention code [1] 329212 0
Treatment: Other
Intervention code [2] 329426 0
Treatment: Devices
Comparator / control treatment
Sham irradiation (also known as Placebo). The sham irradiation will involve placing the device in the patients mouth and applying it to the area of interest for 60 seconds however the device is not switched on. As the device is in the mouth, the patient will not be aware whether they are received treatment or the placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 339022 0
Duration of anaesthesia
Timepoint [1] 339022 0
Every 15 minutes post-treatment until participants select 'none' in post operative diary, etc.
Secondary outcome [1] 438288 0
None
Timepoint [1] 438288 0
None

Eligibility
Key inclusion criteria
Adult dental patients (aged 18 years and above) and child dental patients (aged 6-17 years) who require adental injection as part of routine dental treatment will be invited to participate in the study. The registered dental practitioner or dental specialist will screen the patient and those who adhere to theinclusion criteria will be invited to participate.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are deemed ineligible if they require two different injections in two seperate quadrants on the same side.

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 50/50 randomisation using a computerised coin-toss generator: https://coinfl ipgenerator.com/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All raw data will be converted into a quantitative form for ease of analysis. Analysis will use Graphpad Prism(version 9) and SPSS software (Version 29, IBM Corporation, 2020). Bivariate and multivariate analyses willbe conducted to compare measured outcomes. A p value of <0.05 will be used as the threshold forstatistical signifi cance. Data will be divided into the two intervention groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317015 0
University
Name [1] 317015 0
The University of Queensland, School of Dentistry
Country [1] 317015 0
Australia
Primary sponsor type
University
Name
The University of Queensland, School of Dentistry
Address
Country
Australia
Secondary sponsor category [1] 319260 0
Commercial sector/Industry
Name [1] 319260 0
Dentroid
Address [1] 319260 0
Country [1] 319260 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315771 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 315771 0
Ethics committee country [1] 315771 0
Australia
Date submitted for ethics approval [1] 315771 0
12/08/2024
Approval date [1] 315771 0
Ethics approval number [1] 315771 0

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

Contacts
Principal investigator
Name 135742 0
Dr Jessica Zachar
Address 135742 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 135742 0
Australia
Phone 135742 0
+61 7 3365 8055
Fax 135742 0
Email 135742 0
[email protected]
Contact person for public queries
Name 135743 0
Jessica Zachar
Address 135743 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 135743 0
Australia
Phone 135743 0
+61 7 3365 8055
Fax 135743 0
Email 135743 0
[email protected]
Contact person for scientific queries
Name 135744 0
Jessica Zachar
Address 135744 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 135744 0
Australia
Phone 135744 0
+61 7 3365 8055
Fax 135744 0
Email 135744 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.