Investigating red light therapy for pulpal analgesia during dental fillings

Objective: Compare the efficacy of pulpal analgesia following photobiomodulation (PBM) with a multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) to traditional local dental anaesthesia for dental restorations. Intervention: Each participant will be randomly selected to receive application of traditional local dental anaesthesia or the Nuralyte® device prior to the dental restoration. 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 restoration 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 traditional local dental anaesthesia or the Nuralyte® device prior to the dental restoration. 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. If multiple restorations are required, the participant will receive the same mode of delivery for each tooth. Afterwards, participants will be asked to report on the level of discomfort felt during the dental restoration. 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 • Restorative surface/s, dentine depth during cavity preparation • Whether the Nuralyte device or traditional local anaesthesia was used • If local anaesthesia was used; 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