None listed
Conditions
Brief summary
Fear of dental anaesthetic injection can produce anxiety and contribute to dental phobia. Recently, alternative methods for producing effective anaesthesia that reduce the pain experienced during dental procedures have been investigated. One such method is Photobiomodulation (PBM) which uses light to transiently block nerve transmission of pain. Clinical trials have shown that some lasers can generate analgesia using PBM. For example, Sattayut et al in 2014 used a 790nm diode laser (27.69 J/cm2) before palatal injections and found the level of analgesia to be similar to a 20% benzocaine topical gel. Similarly, Khan et al in 2023 found topical anaesthesia produced by a 980nm diode laser (15 J/cm2) to be superior to 2% Lidocaine gel in the administration of inferior alveolar nerve blocks. There are currently no studies that have investigated the efficacy of LED devices utilising PBM for topical anaesthesia before dental injections (inferior alveolar nerve block, palatal infiltration, palatal block and buccal infiltration). Therefore, the purpose of this study is to investigate whether a polychromatic light emitting diode (LED) device (Nuralyte®, Dentroid Canberra, Australia) can lower pain for dental injections when compared with traditional topical anaesthetic gel (5% xylocaine). It is hypothesised that the multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) will lower pain from pain dental injections signifi cantly when compared to topical anaesthetic gel (5% xylocaine). This study is being completed as part of Dr Jessica Zachar's Doctor of Philosophy (PhD) program at The University of Queensland.
Interventions
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)
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
Sponsors
The University of Queensland, School of Dentistry
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed