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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
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Scientific title
A trial exploring the reversal of numbness after dental local anaesthetic injections using LED photobiomodulation in adult and child dental patients.
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Secondary ID [1]
312583
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None
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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:
Dental analgesia
334679
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Dental anaesthesia
334680
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Condition category
Condition code
Anaesthesiology
331251
331251
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0
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Anaesthetics
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Oral and Gastrointestinal
331252
331252
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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
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.
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Intervention code [1]
329212
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Treatment: Other
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Intervention code [2]
329426
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Treatment: Devices
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Duration of anaesthesia
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Assessment method [1]
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Post operative diary with 3 options to choose
None
Tingling/partial numbness
Complete numbness
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Timepoint [1]
339022
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Every 15 minutes post-treatment until participants select 'none' in post operative diary, etc.
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Secondary outcome [1]
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None
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Assessment method [1]
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None
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Timepoint [1]
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None
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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.
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Minimum age
6
Years
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Maximum age
No limit
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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
Participants are deemed ineligible if they require two different injections in two seperate quadrants on the same side.
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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)
Allocation is not concealed.
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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/
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
317015
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University
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Name [1]
317015
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The University of Queensland, School of Dentistry
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Address [1]
317015
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Country [1]
317015
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Australia
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Primary sponsor type
University
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Name
The University of Queensland, School of Dentistry
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Address
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Country
Australia
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Secondary sponsor category [1]
319260
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Commercial sector/Industry
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Name [1]
319260
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Dentroid
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Address [1]
319260
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Country [1]
319260
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315771
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The University of Queensland Human Research Ethics Committee A
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Ethics committee address [1]
315771
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https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics
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Ethics committee country [1]
315771
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Australia
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Date submitted for ethics approval [1]
315771
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12/08/2024
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Approval date [1]
315771
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Ethics approval number [1]
315771
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Summary
Brief summary
Dental local anaesthetic injections cause prolonged numbness of the oral and peri-oral tissues, lasting several hours. This impairs normal functions. Patients can experience self-inflicted injuries such as biting of the cheek and tongue particularly in children. Hence there is interest in methods that can reduce the duration of numbness after dental injections. Three recent studies have shown that visible red diode laser radiation (660 or 810 nm) can give a useful reduction in duration of numbness after dental injections in children, reducing the time of lip numbness by 40-56 minutes. The purpose of this study is to investigate whether a polychromatic light emitting diode device (e (Nuralyte®, Dentroid Canberra, Australia) that emits visible red and near infrared light can likewise reducing the time of numbness, in both adults and children, after dental injections, comparing the active light source to sham irradiation (single blinding for the participants). It is hypothesised that the multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) will reduce the numbness time significantly when compared to the sham exposure.
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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 Jessica Zachar
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Address
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The University of Queensland, 288 Herston Road, Herston 4006 QLD
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Country
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Australia
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Phone
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+61 7 3365 8055
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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
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Jessica Zachar
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Address
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The University of Queensland, 288 Herston Road, Herston 4006 QLD
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Country
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Australia
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Phone
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+61 7 3365 8055
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Jessica Zachar
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Address
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The University of Queensland, 288 Herston Road, Herston 4006 QLD
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Country
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Australia
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Phone
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+61 7 3365 8055
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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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