Anesthesia, Local, Needle Phobia
Conditions
Keywords
Needle-free injection, Dental anesthesia, Infiltration, Nerve block
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.
Interventions
COMBINATION_PRODUCTMeso-Jet, 2% lidocaine(xylocaine)
Performing local dental anesthesia using needle-free liquid jet injection with different parameters (pressure, volume, injection technique). Anesthetic agent: 2% lidocaine with 1:100,000 epinephrine, dose: 0.3-2ml.
COMBINATION_PRODUCTNeedle,2% lidocaine(xylocaine)
Performing local dental anesthesia using syringe and needles, same as regular clinical practice. Anesthestic agent: 2% lidocaine with 1:100,000 epinephrine,dose: 0.3-2ml.
Sponsors
MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Each participant receive two anesthesia methods randomly. Total 8 arms, 4 groups, each group will recruit 6 participants. Incase of drop out, a total of 30 participant will be enrolled.
Intervention model description
Randomized split-mouth cross-over clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to initiation of anesthesia | 1 minute after injection | Time to initiation of anesthesia feeling, measured by a simple pinch test using a periodontal probe |
| Time to termination of anesthesia | 3 hours after injection | Time to termination of anesthesia feeling, measured by a simple pinch test using a periodontal probe |
| Dental pulp anesthesia | 10 minutes after injection. | Dental pulp anesthesia result is measured by an electric pulp test(EPT), successful anesthesia for dental pulp exhibits an EPT at 80. |
| Efficacy of dental pulp anesthesia | 10 minutes after injection. | The number of sucessful dental pulp anesthesia cases over total number of participants in the group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse effect during follow-up period[safety] | up to 7 days | Incidence of adverse effect after aneshesia procedure during follow-up period, such as: ulcer, hematoma, discomfort, abnormal feeling, nerve damage. |
| Anxiety level during injection | 10 seconds after the injection. | Participants' anxiety level when receiving the needle or needle-free injection, measured by visual analogue scale for anxiety.From 0 to 10, 0 stands for Not at all Anxious, 10 stands for Extremely Anxious. Higher score means a worse outcome. |
| Taste preference | 1 minute after the injection | Participants' taste preference after needle or needle-free injection, measured by 9-point hedonic scale for measuring food acceptability. From 1 to 9, 1 stands for dislike extremely, 5 stands for neither like or dislike, 9 stands for like extremely. Higher score means a better outcome. |
| Incidence of adverse effect [safety] | 10 seconds after injection. | Incidence of adverse effect immediately after aneshesia injection, such as tissue damage, bleeding, hematoma. |
| Baseline pain level | 1 minute before injection | Participants' pain level before receiving the needle or needle-free injection, measured by standard visual analog scale for pain. From 0 to 10, 0 stands for no pain, 10 stands for worst pain. Higher score means a worse outcome. |
| Pain level during injection | 10 seconds after the injection | Participants' pain level when receiving the needle or needle-free injection, measured by standard visual analog scale for pain. From 0 to 10, 0 stands for no pain, 10 stands for worst pain. Higher score means a worse outcome. |
| Baseline anxiety level | 1 minute before injection | Participants' anxiety level before receiving the needle or needle-free injection, measured by visual analogue scale for anxiety. From 0 to 10, 0 stands for Not at all Anxious, 10 stands for Extremely Anxious. Higher score means a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Barriers | through study completion, from date of recruitment until the date of last follow-up case complition, an average of 6 month. | Record possible barriesrs in recruitment,randomization,operation. |
| Participant's feedbacks | 20 minutes after all procedures. | Reord participants's feedbacks about the whole trial, such as: overall feelings, preferences,complains. |
Countries
Canada
Outcome results
None listed