Clinical trial NCT04493528: Needle-free Dental Anesthesia
Official title: Needle-free Dental Anesthesia: a Pilot Split-mouth Cross-over Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Anesthesia, Local
Needle Phobia
Keywords: Needle-free injection
Dental anesthesia
Infiltration
Nerve block
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.
First posted: 2020-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized split-mouth cross-over clinical trial.
Primary purpose: TREATMENT

Brief summary: Many patients experience pain and anxiety from traditional needle anesthesia and may avoid necessary dental treatments. The needle-free liquid jet injection(NFLJI) could solve these problems. NFLJI delivers drug solutions by creating a micro-thin pressure liquid jet to penetrate the skin and disperse in the soft tissue. It has many advantages like eliminating injection pain, needle phobia and needle disposal. However, anesthesia techniques in dentistry were all developed for needle injection, and they are not very effective for NFLJI. Moreover, clinical trials of dental anesthesia using NFLJI have shown inconsistent efficacy.

In this study, we aim to compare the clinical efficacy between NFLJI and needle dental anesthesia in pilot split-mouth cross-over randomized clinical trials, assess the feasibility to conduct such trial on a larger scale.

Participants will be assigned to one of the following four groups: 1. Infiltration on a maxillary lateral incisor,2. Inferior alveolar nerve block, 3.Mental nerve block, 4. Infraorbital nerve block. Each participant will receive one injection with a needle and another one with NFLJI randomly at the same appointment. A washout period of 1 hour between two procedures for participants' to forget the previous experience. Needle injection will be performed according to clinical standards. NFLJI will be performed according to a guideline developed in our research group. Participants will stay in the clinic until the anesthesia effect disappear and be followed for one week.

The primary outcome is the efficacy and effect of two anesthesia interventions. The secondary outcome is the pain and anxiety visual analogue scale before and during injection, taste preference, and complications. Additionally, patients' overall feelings for two interventions as well as any barriers to conducting such a trial will be recorded.


Eligibility criteria: Inclusion Criteria:

* age between 18-35 years-old
* fluent in English
* cooperate

Exclusion Criteria:

* has a history of chronic pain,
* has a systematic disease,
* has root canal therapy at the upper lateral incisor/lower posterior teeth region.

Primary outcomes:
measure: Dental pulp anesthesia
timeFrame: 10 minutes after injection.
measure: Efficacy of dental pulp anesthesia
timeFrame: 10 minutes after injection.
measure: Time to initiation of anesthesia
timeFrame: 1 minute after injection
measure: Time to termination of anesthesia
timeFrame: 3 hours after injection
Secondary outcomes:
measure: Baseline pain level
timeFrame: 1 minute before injection
measure: Pain level during injection
timeFrame: 10 seconds after the injection
measure: Baseline anxiety level
timeFrame: 1 minute before injection
measure: Anxiety level during injection
timeFrame: 10 seconds after the injection.
measure: Taste preference
timeFrame: 1 minute after the injection
measure: Incidence of adverse effect [safety]
timeFrame: 10 seconds after injection.
measure: Incidence of adverse effect during follow-up period[safety]
timeFrame: up to 7 days
Other outcomes:
measure: Participant's feedbacks
timeFrame: 20 minutes after all procedures.
measure: Barriers
timeFrame: through study completion, from date of recruitment until the date of last follow-up case complition, an average of 6 month.
Locations:
city: Montréal
country: Canada
facility: McGill University Faculty of Dentistry
state: Quebec
Study officials:
affiliation: McGill University Faculty of Dentistry
name: Faleh Tamimi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: