Needle-free Dental Anesthesia
- Conditions
- Anesthesia, LocalNeedle Phobia
- Interventions
- Combination Product: Needle,2% lidocaine(xylocaine)Combination Product: Meso-Jet, 2% lidocaine(xylocaine)
- Registration Number
- NCT04493528
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 30
- age between 18-35 years-old
- fluent in English
- cooperate
- has a history of chronic pain,
- has a systematic disease,
- has root canal therapy at the upper lateral incisor/lower posterior teeth region.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Needle Infiltration anesthesia Needle,2% lidocaine(xylocaine) 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). Needle mental nerve block Needle,2% lidocaine(xylocaine) 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). Needle-free mandibular nerve block Meso-Jet, 2% lidocaine(xylocaine) 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-free infiltration anesthesia Meso-Jet, 2% lidocaine(xylocaine) 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). Needle-free mental nerve block Meso-Jet, 2% lidocaine(xylocaine) 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 Needle,2% lidocaine(xylocaine) 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). Needle-free infraorbital nerve block Meso-Jet, 2% lidocaine(xylocaine) 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). Needle infraorbital nerve block Needle,2% lidocaine(xylocaine) 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).
- Primary Outcome Measures
Name Time Method 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.
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.
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
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
Trial Locations
- Locations (1)
McGill University Faculty of Dentistry
🇨🇦Montréal, Quebec, Canada