None listed
Conditions
Brief summary
Dental local anaesthetic injections cause prolonged numbness of the oral and peri-oral tissues, lasting several hours. This impairs normal functions. Patients can experience self-inflicted injuries such as biting of the cheek and tongue particularly in children. Hence there is interest in methods that can reduce the duration of numbness after dental injections. Three recent studies have shown that visible red diode laser radiation (660 or 810 nm) can give a useful reduction in duration of numbness after dental injections in children, reducing the time of lip numbness by 40-56 minutes. The purpose of this study is to investigate whether a polychromatic light emitting diode device (e (Nuralyte®, Dentroid Canberra, Australia) that emits visible red and near infrared light can likewise reducing the time of numbness, in both adults and children, after dental injections, comparing the active light source to sham irradiation (single blinding for the participants). It is hypothesised that the multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) will reduce the numbness time significantly when compared to the sham exposure.
Interventions
Objective: Compare reversal of numbness following photobiomodulation (PBM) with a multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) to sham exposure.
Intervention: Participant blinded treatment at the end of a dental visit where a local anaestetic injection has been made as part of the normal procedure, using either sham irradiation or actual light exposure with the Nuralyte® (Dentroid Canberra, Australia) - Light-emitting diode (LED) device. This emits light from 700-1100 n
Objective: Compare reversal of numbness following photobiomodulation (PBM) with a multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) to sham exposure. Intervention: Participant blinded treatment at the end of a dental visit where a local anaestetic injection has been made as part of the normal procedure, using either sham irradiation or actual light exposure with the Nuralyte® (Dentroid Canberra, Australia) - Light-emitting diode (LED) device. This emits light from 700-1100 nm, and has a spot size of 7 mm. This will be used to treat the area of the injection on the mucosa - 4 adjacent spots with 15 secs each (4 J/cm2), with the device held 2 mm away from the soft tissues. It will be applied as a once off for a total of 60 seconds. The recovery to normal as numbness reduces over time will be assessed using standard measures and recorded in a post-operative diary. Details of the type and volume of anaesthetic agent used will be recorded. 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 sham exposure or the Nuralyte® device after completion of dental treatment which required local anaesthesia. Afterwards, participants will be asked to report on the level of numbness every 15 minutes until complete resolution with a post operative diary.
Sponsors
The University of Queensland, School of Dentistry
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
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 adental injection as part of routine dental treatment will be invited to participate in the study. The registered dental practitioner or dental specialist will screen the patient and those who adhere to theinclusion criteria will be invited to participate.
Exclusion criteria
Participants are deemed ineligible if they require two different injections in two seperate quadrants on the same side.
Outcome results
None listed