Needle-free Dental Anesthesia

Study Overview
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Brief Summary
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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.

Official Title
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Needle-free Dental Anesthesia: a Pilot Split-mouth Cross-over Randomized Clinical Trial.

Conditions
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Anesthesia, Local, Needle Phobia

Intervention / Treatment
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* Combination Product: Meso-Jet, 2% lidocaine(xylocaine)
* Combination Product: Needle,2% lidocaine(xylocaine)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized split-mouth cross-over clinical trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Needle Infiltration anesthesia<br>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). | Combination Product: Needle,2% lidocaine(xylocaine)<br>* 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.<br>|
| Experimental: Needle-free infiltration anesthesia<br>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). | Combination Product: Meso-Jet, 2% lidocaine(xylocaine)<br>* 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.<br>* Other names: NFLJI (Needle-free liquid jet injection system);|
| Active Comparator: Needle mental nerve block<br>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). | Combination Product: Needle,2% lidocaine(xylocaine)<br>* 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.<br>|
| Experimental: Needle-free mental nerve block<br>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). | Combination Product: Meso-Jet, 2% lidocaine(xylocaine)<br>* 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.<br>* Other names: NFLJI (Needle-free liquid jet injection system);|
| Active Comparator: Needle mandibular nerve block<br>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). | Combination Product: Needle,2% lidocaine(xylocaine)<br>* 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.<br>|
| Experimental: Needle-free mandibular nerve block<br>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). | Combination Product: Meso-Jet, 2% lidocaine(xylocaine)<br>* 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.<br>* Other names: NFLJI (Needle-free liquid jet injection system);|
| Active Comparator: Needle infraorbital nerve block<br>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). | Combination Product: Needle,2% lidocaine(xylocaine)<br>* 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.<br>|
| Experimental: Needle-free infraorbital nerve block<br>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). | Combination Product: Meso-Jet, 2% lidocaine(xylocaine)<br>* 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.<br>* Other names: NFLJI (Needle-free liquid jet injection system);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Needle-free injection, Dental anesthesia, Infiltration, Nerve block