Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000589482p
Ethics application status
Submitted, not yet approved
Date submitted
20/05/2025
Date registered
6/06/2025
Date last updated
6/06/2025
Date data sharing statement initially provided
6/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating red light therapy in managing post operative pain after dental extractions
Scientific title
A trial comparing the efficacy of polychromatic light-emitting diode therapy in managing post operative pain following dental extractions (simple or surgical) in adults
Secondary ID [1] 314504 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental analgesia 337567 0
Postoperative pain 337568 0
Dental extractions 337678 0
Condition category
Condition code
Oral and Gastrointestinal 333915 333915 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 333916 333916 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Objective: Compare the efficacy of post operative pain after dental extractions with a multiwavelength light emitting diode (LED) device (Nuralyte®, Dentroid Canberra, Australia) to sham exposure.

Intervention: Participants will be attending a dental appointment for a dental extraction (simple or surgical). They will then be randomly chosen to receive either a light emitting diode with the Nuralyte® device for 2-4 minutes or a placebo (inactive light). After the dental extraction, they will be asked to report the level of discomfort on days 2,3,4 via mobile text message.

• Group 1: Placebo – 1 minute buccal and 1 minute lingual of socket = 2min total
• Group 2: Blend mode - 1 minute buccal and 1 minute lingual of socket = 2min total
• Group 3: Boost mode - 2 minute buccal and 2 minute lingual of socket = 4min total

This study will test the effects on post-operative pain of two different light wavelengths from the LED array in the Nuralyte. The device uses a custom-build LED array that has 4 separate LED emitters (700, 850, 970 and 1050 nm). The spectral width of the emitted light from each of these emitters is as follows (40 nm width, 60 nm width, 160 nm width, 100 nm width).

The first of the light wavelengths to be tested is 1050 nm. This wavelength is very similar to that of the Nd:YAG ( neodymium-doped yttrium aluminum garnet; Nd:Y3Al5O12) laser (1064 nm), which has known analgesic actions when used for treating pain. For this, the Nuralyte will be used in "Boost" mode, where only the 1050 nm LED light is powered. This 1010 nm LED emitter delivers an optical power of 300 mW. An exposure time of 60 seconds will give a delivered dose to the site of 18 Joules.

The second setting is to use all 4 different light wavelengths in combination (i.e. 700, 850, and 970 nm as well as 1050 nm). The rationale here is that each of the 3 shorter wavelengths also can contribute to analgesic pain-relieving actions. For this, the Nuralyte will be used in "Blend" mode, where all 4 LEDs operate simultaneously to deliver light from the device. When all 4 LEDs operate, the total combined optical power of is 1000 mW (i.e. 300 mW from 1050 nm, plus a total of 700 mW from the 3 other LEDs). As the total power is greater in Blend mode than Boost mode, the exposure time on Blend mode will be only 20 seconds rather than 60 seconds, so that the delivered dose to the treated site remains comparable, at 20 Joules.

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) who require a dental extraction 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 immediately after the completion of the dental extraction.

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 (Federeal dental international notation), patient age and gender
• Type of extraction – simple, sectional, surgical (311,314,322,324)
• If flap was raised, if bone was removed
• Pell & Gregory classification if lower 3rd molar
• Approximate time of procedure
• Local anaesthetic given and amount given
• Clinician rating complexity of procedure
• If performed under local anaesthetic, nitrous, intravenous sedation or general anaesthetic
• Dentist name and clinic location
• Patient mobile number
• Reported visual analogue (VAS) pain scale for adult participants (score 1-10) on days 2,3,4
Intervention code [1] 331125 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] 341559 0
Post operative discomfort after dental extraction
Timepoint [1] 341559 0
Days 2,3,4 (after dental extraction)
Secondary outcome [1] 447930 0
Difficulty of dental extraction
Timepoint [1] 447930 0
During dental extraction

Eligibility
Key inclusion criteria
Adult dental patients (aged 18 years and above) who require a dental extraction 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
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who have compromised healing:
- Current usage of steroids /corticosteroids
- Current usage of immunosuppressants, immunomodulators or antiangiogenics
- Current usage of antiresorptive drugs e.g denosumab or current/history of oral/IV bisphosphonates
- Previous history or current head and neck radiation or current chemotherapy
- Smoker
- Diabetic
- Liver disease of kidney disease
- Autoimmune disease
- Short term postoperative analgesia, antibiotics and steroids after dental extraction is permitted

Participants are also 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, temporo-mandibular disorders. Other exclusion criteria include those who are pregnant, 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 1 in 3 randomisation using a computerised randomiser generator: https://numbergenerator.org/randomnumbergenerator/1-3
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 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
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD

Funding & Sponsors
Funding source category [1] 319041 0
University
Name [1] 319041 0
The University of Queensland School of Dentistry
Country [1] 319041 0
Australia
Primary sponsor type
University
Name
The University of Queensland School of Dentistry
Address
Country
Australia
Secondary sponsor category [1] 321508 0
Commercial sector/Industry
Name [1] 321508 0
Dentroid
Address [1] 321508 0
Country [1] 321508 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317649 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 317649 0
Ethics committee country [1] 317649 0
Australia
Date submitted for ethics approval [1] 317649 0
12/05/2025
Approval date [1] 317649 0
Ethics approval number [1] 317649 0

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

Contacts
Principal investigator
Name 141694 0
Dr Jessica Zachar
Address 141694 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 141694 0
Australia
Phone 141694 0
+61 7 3365 8055
Fax 141694 0
Email 141694 0
[email protected]
Contact person for public queries
Name 141695 0
Jessica Zachar
Address 141695 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 141695 0
Australia
Phone 141695 0
+61 7 3365 8055
Fax 141695 0
Email 141695 0
[email protected]
Contact person for scientific queries
Name 141696 0
Jessica Zachar
Address 141696 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 141696 0
Australia
Phone 141696 0
+61 7 3365 8055
Fax 141696 0
Email 141696 0
[email protected]

Data sharing statement
Will the study consider sharing 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.