None listed
Conditions
Brief summary
The goal of this project is to examine the efficacy and acceptability of a needle-free dental anaesthetic delivery system. This will be achieved by implementing the following steps:1. Conduct pilot clinical testing/validation of the new injection system for dental local anaesthesia;2. Measure levels of anxiety and discomfort of participants treated with the needle-free device and via conventional dental local anaesthetic; 3. Evaluate, by photographs and questionnaires at 1, 3 and 7 days, any subsequent discomfort and the response of gingival tissues to anaesthetic delivery (i.e. whether the healing is progressing normally) via the needle-free method and compare with the known gingival response to conventional local anaesthesia; 4. Evaluate the volume of anaesthetic dispensed with the needle-free device and via a conventional dental local anaesthetic application. We hypothesize our needle-free device will have similar or better acceptability by patients than conventional methods via syringe which will be examined in subsequent trials.
Interventions
The pilot/feasibility clinical testing of this device will involve treating 10 adult participants who require extractions in preparation for denture placement or prior to orthodontic treatment. Participants will be recruited from the Dunedin area, taking care that Maori/Pacific individuals are included in the patient cohort. All participants will be treated by the same two dentists, at the Otago Faculty of Dentistry. Extractions will be performed on the upper jaw only. Anaesthesia for one side o
The pilot/feasibility clinical testing of this device will involve treating 10 adult participants who require extractions in preparation for denture placement or prior to orthodontic treatment. Participants will be recruited from the Dunedin area, taking care that Maori/Pacific individuals are included in the patient cohort. All participants will be treated by the same two dentists, at the Otago Faculty of Dentistry. Extractions will be performed on the upper jaw only. Anaesthesia for one side of the jaw will be placed by one of the researchers via conventional infiltration procedures using a needle and syringe, while the other side will have dental local anaesthetic delivered with our needle-free device. The allocation of techniques will be randomised for each patient (i.e. either left or right side will receive either procedure). The anaesthetic Articaine (Articaine hydrochloride 4% 88 mg with adrenaline 1:100,000 22 micrograms) will be placed around teeth in both sides of the jaw, either via needle and syringe (control) or using our needle-free device (test). 1-2ml (20 – 100mg Articaine HCl) of local anaesthetic, which is the standard dose for adults, will be delivered on both sides prior to tooth extraction. Weight not a factor in determining dose. Adherence to the intervention will be assured by adding the location of anaesthetic placement to the patient's notes as part of our study records. An accepted standard test will be used to ensure the teeth are numb prior to extraction, and additional local anaesthetic will be given, using the same mode either conventional or with a needle free device, if needed as per normal practice. Another dentist part of the research team, who is blinded to which anaesthetic technique has been used on each side, will perform the tooth extractions. Post-operatory care will follow conventional methods.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Older than 18 years of age; planned upper bilateral extractions as part of normal treatment plan; no major co-occurring health conditions that may affect the ability of participating in the study; no additional requirement to have a diagnosis of dental anxiety. Males and females older than 18 years of age of all ethnicities will be invited to participate. At least some participants who identify as Maori and some as Pasifika will be included.
Exclusion criteria
Abscesses or extensive periodontal disease; upper and lower extractions.
Outcome results
None listed