Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001265561p
Ethics application status
Not yet submitted
Date submitted
2/10/2024
Date registered
16/10/2024
Date last updated
16/10/2024
Date data sharing statement initially provided
16/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating red light therapy for hypersensitive teeth during dental cleans
Scientific title
A study comparing the effectiveness of polychromatic light-emitting diode therapy for managing hypersensitive teeth during supragingival debridements in adults.
Secondary ID [1] 313046 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental analgesia 335269 0
Dental anaesthesia 335270 0
Dental hypersensitivity 335430 0
Condition category
Condition code
Oral and Gastrointestinal 331842 331842 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 331843 331843 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Objective: Compare the efficacy of pulpal analgesia following photobiomodulation (PBM) with a multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) for hypersensitive teeth during supragingival debridements.

Intervention: Participant blinded treatment for hypersensitive teeth during a supragingival debridement using either sham irradiation or actual light exposure with the Nuralyte® (Dentroid Canberra, Australia) - Light-emitting diode (LED) device.

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) who require a supragingival debridement 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 if a hypersensitive teeth is detected during a supragingival debridement. If multiple sensitive teeth are detected, they may recieie the same intervention during the cleaning session.

If the Nuralyte device is to be used it will be applied to the tooth as a once off, for 60 seconds and adherence will be via direct observation by the dental practitioner.
The operator needs to wait two minutes and can continue cleaning other teeth before returning to the tooth of interest with hypersensitivity for further cleaning.

Afterwards, participants will be asked to report on the level of discomfort felt during the supraginginval debridement of that particular tooth.

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
• Pre-screening for history of hypersensitive teeth
- Do you feel a short, sharp sensation in your teeth when you consume something cold, hot, sweet, or sour? and How often do you feel this short, sharp sensation in your teeth?
• Brand of scaler used e.g EMS, Cavitron etc
• Setting of the scaler %
• Reported VAS pain scale for adult participants (1-10) at two time points
Time point 1: When the hypersensitive tooth is detected during the supragingival clean
Time point 2: After the hypersensitive tooth has received either Nuralyte or sham
Intervention code [1] 329598 0
Treatment: Other
Intervention code [2] 329599 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] 339462 0
Discomfort during supragingival debridement.
Timepoint [1] 339462 0
Time point 1: When the hypersensitive tooth is detected during the supragingival clean
Time point 2: After the hypersensitive tooth has received either Nuralyte or sham
Secondary outcome [1] 440064 0
If the participant requests for a reduction in the intensity of the ultrasonic debridement device.
Timepoint [1] 440064 0
During the dental treatment.
Secondary outcome [2] 440535 0
If the patient requests the requirement of manual hand instrumentation.
Timepoint [2] 440535 0
During the dental treatment.

Eligibility
Key inclusion criteria
Adult dental patients (aged 18 years and above) who require a supragingival debridement 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. If a participant does not experience hypersensitive teeth during the debridement, they will be excluded from the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who require sub-gingival debridement e.g ADA dental treatment code 222.
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, 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
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
1/11/2024
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] 317487 0
University
Name [1] 317487 0
The University of Queensland, School of Dentistry
Country [1] 317487 0
Australia
Primary sponsor type
University
Name
The University of Queensland, School of Dentistry
Address
Country
Australia
Secondary sponsor category [1] 319779 0
Commercial sector/Industry
Name [1] 319779 0
Dentroid
Address [1] 319779 0
Country [1] 319779 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316200 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 316200 0
Ethics committee country [1] 316200 0
Australia
Date submitted for ethics approval [1] 316200 0
31/10/2024
Approval date [1] 316200 0
Ethics approval number [1] 316200 0

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

Contacts
Principal investigator
Name 137118 0
Dr Jessica Zachar
Address 137118 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 137118 0
Australia
Phone 137118 0
+61 7 3365 8055
Fax 137118 0
Email 137118 0
[email protected]
Contact person for public queries
Name 137119 0
Jessica Zachar
Address 137119 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 137119 0
Australia
Phone 137119 0
+61 7 3365 8055
Fax 137119 0
Email 137119 0
[email protected]
Contact person for scientific queries
Name 137120 0
Jessica Zachar
Address 137120 0
The University of Queensland, 288 Herston Road, Herston 4006 QLD
Country 137120 0
Australia
Phone 137120 0
+61 7 3365 8055
Fax 137120 0
Email 137120 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.