Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001090505p
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 Ease Pain from Dental Injections
Scientific title
A trial comparing the efficacy of a polychromatic light emitting diode versus topical anaesthetic gel in reducing pain from dental injections in adult and child dental patients
Secondary ID [1] 312574 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental analgesia 334494 0
Dental anaesthesia 334506 0
Condition category
Condition code
Anaesthesiology 331108 331108 0 0
Pain management
Oral and Gastrointestinal 331121 331121 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 injection pain following photobiomodulation (PBM) with a multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) to topical anaesthetic gel (5% xylocaine).

Intervention: Each participant will be randomly selected to receive application of either 5% xylocaine gel or the Nuralyte® device prior to the required local anaesthetic injection.

The device used in this study is a polychromatic light-emitting diode (LED) device (Nuralyte®, Dentroid Canberra, Australia). It emits wavelengths of light from 700-1100nm with a spot size of 7mm and a measured power output of 113mW. The standard exposure time is 60 sec which will result in application of 6.77J of energy to the site with an energy density of 17.6 J/cm2.

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 5% xylocaine gel or the Nuralyte® device prior to the required local anaesthetic injection. If the Nuralyte device is to be used it will be applied to the injection site as a once off, for 60 seconds and adherence will be via direct observation by the dental practitioner.

Afterwards, participants will be asked to report on the level of discomfort felt during the injection. Heart rate during the injection may also be recorded with a pulse oximeter.

The registered general dental practitioner or dental specialist will also be required to record the following parameters at the time of the appointment on the provided data collection sheet:
• Tooth of interest (FDI notation), patient age and gender and procedure type
• Needle target site, needle type, injection type and type of local anaesthetic
• Type of vasoconstrictor, percentage of local anaesthesia and amount of local anaesthesia
• Reported VAS pain scale for adult participants (1-10) or Wong Baker scale (facial illustrations) and FLACC scale (Face, Legs, Activity, Cry, Consolability) for child participants
• Maximum heart rate reported during injection as per pulse oximeter readings
• Whether the Nuralyte device or topical gel was used
Intervention code [1] 329093 0
Treatment: Other
Intervention code [2] 329425 0
Treatment: Devices
Comparator / control treatment
The comparator is Xylocaine 5% gel and a single application of approximately 300mg delivered to the injection site with a cotton bud.

Control group
Active

Outcomes
Primary outcome [1] 338871 0
Discomfort during dental injection.
Timepoint [1] 338871 0
Immediately after the administration of a dental injection
Secondary outcome [1] 437736 0
Heart rate during dental injection.
Timepoint [1] 437736 0
During the dental injection the pulse oximeter will record the heart rate at every second and the maximum number will be recorded.

Eligibility
Key inclusion criteria
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.
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 have systemic conditions or are taking drugs that could influence pain perception. This includes oro-facial pain disorders, neurological/ cognitive/psychiatric conditions, obstructive sleep apnoea, and analgesic medications. Other exclusion criteria include those who lack the capacity for consent or those unable to comprehend pain

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://coinflipgenerator.com/
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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 will be conducted to compare measured outcomes. A p value of <0.05 will be used as the threshold for statistical significance. 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] 316992 0
University
Name [1] 316992 0
The University of Queensland, School of Dentistry
Country [1] 316992 0
Australia
Primary sponsor type
University
Name
The University of Queensland, School of Dentistry
Address
Country
Australia
Secondary sponsor category [1] 319239 0
Commercial sector/Industry
Name [1] 319239 0
Dentroid
Address [1] 319239 0
Country [1] 319239 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315747 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 315747 0
Ethics committee country [1] 315747 0
Australia
Date submitted for ethics approval [1] 315747 0
23/08/2024
Approval date [1] 315747 0
Ethics approval number [1] 315747 0

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

Contacts
Principal investigator
Name 135682 0
Dr Jessica Zachar
Address 135682 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 135682 0
Australia
Phone 135682 0
+61 7 3365 8055
Fax 135682 0
Email 135682 0
[email protected]
Contact person for public queries
Name 135683 0
Jessica Zachar
Address 135683 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 135683 0
Australia
Phone 135683 0
+61 7 3365 8055
Fax 135683 0
Email 135683 0
[email protected]
Contact person for scientific queries
Name 135684 0
Jessica Zachar
Address 135684 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 135684 0
Australia
Phone 135684 0
+61 7 3365 8055
Fax 135684 0
Email 135684 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.