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Trial registered on ANZCTR


Registration number
ACTRN12621000490875
Ethics application status
Approved
Date submitted
25/02/2021
Date registered
27/04/2021
Date last updated
4/02/2022
Date data sharing statement initially provided
27/04/2021
Date results provided
4/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of needle-free tooth anaesthesia on dental anxiety
Scientific title
The effect of needle-free tooth anaesthesia on dental anxiety in adults receiving planned bilateral extractions
Secondary ID [1] 303480 0
None
Universal Trial Number (UTN)
U1111-1257-3874
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental extraction 320797 0
Dental anaesthesia 320798 0
Condition category
Condition code
Anaesthesiology 318620 318620 0 0
Anaesthetics
Oral and Gastrointestinal 319068 319068 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319834 0
Treatment: Devices
Comparator / control treatment
Standard local anesthetic applied via needle and syringe will be placed on the other side of the jaw (control). 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 of anaesthetic (20 – 100mg Articaine HCl) will be delivered on both sides prior to tooth extraction. Weight is 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.
Control group
Active

Outcomes
Primary outcome [1] 326647 0
Levels of anxiety and discomfort will be measured using the Corah's Dental Anxiety Scale (DAS)
Timepoint [1] 326647 0
Immediately after delivery of local anaesthetic (twice per participant), and 1, 3, and 7 days post-dental extraction
Secondary outcome [1] 392273 0
Response of the gingival tissues to anaesthetic delivery via visual inspection and photographic record of the gingival tissues (qualitative assessment), assessed for both sites separately.
Timepoint [1] 392273 0
Immediately after delivery of local anaesthetic (twice per participant), and 1, 3, and 7 days post-dental extraction
Secondary outcome [2] 393304 0
Volume of anaesthetic dispensed from patient medical records, assessed for both sides separately
Timepoint [2] 393304 0
Immediately after delivery of local anaesthetic

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Abscesses or extensive periodontal disease; upper and lower extractions.

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)
Random draw via sealed opaque envelopes to allocate which side of the mouth will receive the needle-free anaesthetic method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated list of random sequences (balanced by delivery sequence and also by laterality for the first treatment).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other
Other design features
The primary outcome (DAS immediately after delivery of local anaesthetic) will be examined using a crossover study design (with balanced treatment sequences as described above) whereas the secondary longitudinal outcomes will be examined using a split mouth study design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As part of this pilot/feasibility study, the same statistical methods as for a larger trial will be used, with an appreciation that the present study will not have the statistical power or precision required for a larger trial. All data will be presented using appropriate descriptive statistics, in part to aid in the design of such larger trials. For the primary outcome, DAS immediately following delivery of local anaesthetic, a linear mixed model with a random participant effect will be used to compare the delivery methods while adjusting for period (first or second administration). A paired t-test will be used to compare delivery methods in terms of the time and volume outcomes. Standard model diagnostics will be used, with logarithmic transformations, mixed quantile regression, and Mann-Whitney U tests considered as appropriate. While this study is not powered to detect clinically meaningful differences, hypothesis tests will be performed at the two-sided 0.05 level and all estimates will be accompanied by 95% confidence intervals to facilitate consideration of potential clinical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/02/2021
Date of last participant enrolment
Anticipated
30/05/2021
Actual
29/06/2021
Date of last data collection
Anticipated
30/05/2021
Actual
29/06/2021
Sample size
Target
10
Accrual to date
Final
8
Recruitment outside Australia
Country [1] 23489 0
New Zealand
State/province [1] 23489 0
Otago

Funding & Sponsors
Funding source category [1] 307897 0
Government body
Name [1] 307897 0
MedTech Core
Country [1] 307897 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street, North Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 308691 0
None
Name [1] 308691 0
None
Address [1] 308691 0
Country [1] 308691 0
Secondary sponsor category [2] 308692 0
None
Name [2] 308692 0
None
Address [2] 308692 0
Country [2] 308692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307895 0
Northern A Health and Disabilities Ethics Committee
Ethics committee address [1] 307895 0
Ethics committee country [1] 307895 0
New Zealand
Date submitted for ethics approval [1] 307895 0
Approval date [1] 307895 0
10/02/2021
Ethics approval number [1] 307895 0
20/NTA/186

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

Contacts
Principal investigator
Name 108854 0
Prof Paul A. Brunton
Address 108854 0
Division of Health Sciences, University of Otago, 325 Great King Street, North Dunedin, Dunedin 9016
Country 108854 0
New Zealand
Phone 108854 0
+64 03 479 7413
Fax 108854 0
Email 108854 0
paul.brunton@otago.ac.nz
Contact person for public queries
Name 108855 0
Paul A. Brunton
Address 108855 0
Division of Health Sciences, University of Otago, 325 Great King Street, North Dunedin, Dunedin 9016
Country 108855 0
New Zealand
Phone 108855 0
+64 03 479 7413
Fax 108855 0
Email 108855 0
paul.brunton@otago.ac.nz
Contact person for scientific queries
Name 108856 0
Paul A. Brunton
Address 108856 0
Division of Health Sciences, University of Otago, 325 Great King Street, North Dunedin, Dunedin 9016
Country 108856 0
New Zealand
Phone 108856 0
+64 03 479 7413
Fax 108856 0
Email 108856 0
paul.brunton@otago.ac.nz

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?




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.