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COVID-19
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| Name | Class |
|---|---|
| MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Needle Infiltration anesthesia | Active Comparator | Patients received one needle injection of infiltration anesthesia at left or right upper lateral incisors using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine). |
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| Needle-free infiltration anesthesia | Experimental | Patients received one NFLJI (needle-free liquid jet injection) of infiltration anesthesia at left or right upper lateral incisors using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine). |
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| Needle mental nerve block | Active Comparator | Patients received one needle injection of mental nerve block at left or right lower premolar region using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine). |
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| Needle-free mental nerve block | Experimental | Patients received one NFLJI (needle-free liquid jet injection) of mental nerve block at left or right lower premolar region using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine). |
|
| Needle mandibular nerve block | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meso-Jet, 2% lidocaine(xylocaine) | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dental pulp anesthesia | Dental pulp anesthesia result is measured by an electric pulp test(EPT), successful anesthesia for dental pulp exhibits an EPT at 80. | 10 minutes after injection. |
| Efficacy of dental pulp anesthesia | The number of sucessful dental pulp anesthesia cases over total number of participants in the group. | 10 minutes after injection. |
| Time to initiation of anesthesia | Time to initiation of anesthesia feeling, measured by a simple pinch test using a periodontal probe | 1 minute after injection |
| Time to termination of anesthesia | Time to termination of anesthesia feeling, measured by a simple pinch test using a periodontal probe | 3 hours after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline pain level | 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. | 1 minute before injection |
| Pain level during injection |
| Measure | Description | Time Frame |
|---|---|---|
| Participant's feedbacks | Reord participants's feedbacks about the whole trial, such as: overall feelings, preferences,complains. | 20 minutes after all procedures. |
| Barriers | Record possible barriesrs in recruitment,randomization,operation. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faleh Tamimi, Ph.D. | McGill University Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Faculty of Dentistry | Montreal | Quebec | H2X1G1 | Canada |
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Randomized split-mouth cross-over clinical trial.
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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.
Patients received one needle injection of mandibular nerve block at left or right mandibular foramen using 2 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine). |
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| Needle-free mandibular nerve block | Experimental | Patients received one NFLJI (needle-free liquid jet injection) of mandibular nerve block at left or right mandibular foramen using 2 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine). |
|
| Needle infraorbital nerve block | Active Comparator | Patients received one needle injection of infraorbital nerve block at left or right canine fossa using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine). |
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| Needle-free infraorbital nerve block | Experimental | Patients received one NFLJI (needle-free liquid jet injection) of infraorbital nerve block at left or right canine fossa using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine). |
|
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| Needle,2% lidocaine(xylocaine) | Combination Product | 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. |
|
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. |
| 10 seconds after the injection |
| Baseline anxiety level | 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. | 1 minute before injection |
| Anxiety level during 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. | 10 seconds after the injection. |
| Taste preference | 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. | 1 minute after the injection |
| Incidence of adverse effect [safety] | Incidence of adverse effect immediately after aneshesia injection, such as tissue damage, bleeding, hematoma. | 10 seconds after injection. |
| Incidence of adverse effect during follow-up period[safety] | Incidence of adverse effect after aneshesia procedure during follow-up period, such as: ulcer, hematoma, discomfort, abnormal feeling, nerve damage. | up to 7 days |
| through study completion, from date of recruitment until the date of last follow-up case complition, an average of 6 month. |