Anesthesia, LocalNCT04493528
Needle-free Dental Anesthesia
A study testing Meso-Jet, 2% lidocaine(xylocaine) and Needle,2% lidocaine(xylocaine) in people with Anesthesia, Local and Needle Phobia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local, Needle Phobia
- What is being tested?
- Meso-Jet, 2% lidocaine(xylocaine) and Needle,2% lidocaine(xylocaine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jul 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18-35 years-old
- fluent in English
- cooperate
Who cannot join
- has a history of chronic pain,
- has a systematic disease,
- has root canal therapy at the upper lateral incisor/lower posterior teeth region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Needle-free Dental Anesthesia: a Pilot Split-mouth Cross-over Randomized Clinical Trial.
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.
Read more
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.
- Conditions
- Anesthesia, Local, Needle Phobia
- Being tested
- Meso-Jet, 2% lidocaine(xylocaine), Needle,2% lidocaine(xylocaine)
- Keywords
- Needle-free injection, Dental anesthesia, Infiltration, Nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meso-Jet, 2% lidocaine(xylocaine)Combination product
Also called needle-free device, jet injector, NFLJI (Needle-free liquid jet injection system)
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Combination Product: Needle,2% lidocaine(xylocaine) |
| 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). Receives: Combination Product: Meso-Jet, 2% lidocaine(xylocaine) |
| 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). Receives: Combination Product: Needle,2% lidocaine(xylocaine) |
| 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). Receives: Combination Product: Meso-Jet, 2% lidocaine(xylocaine) |
| Needle mandibular nerve block | Active comparator | 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). Receives: Combination Product: Needle,2% lidocaine(xylocaine) |
| 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). Receives: Combination Product: Meso-Jet, 2% lidocaine(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). Receives: Combination Product: Needle,2% lidocaine(xylocaine) |
| 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). Receives: Combination Product: Meso-Jet, 2% lidocaine(xylocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 3 hours after injection
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 minute after the injection
Incidence of adverse effect [safety]
Incidence of adverse effect immediately after aneshesia injection, such as tissue damage, bleeding, hematoma.
Measured: 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.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start18 Jul 2019
- Primary completion15 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized split-mouth cross-over clinical trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.
- Responsible party
- Principal investigator, Faleh Tamimi, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Faleh Tamimi, Ph.D., Principal investigator, McGill University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493528
- Sponsor's protocol ID
- A09-M36-18A
- Status last verified
- Sep 2021
- First submitted
- 22 Jul 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needle-free Dental Anesthesia: a Pilot Split-mouth Cross-over Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04493528
- Acronym / sponsor ID
- A09-M36-18A
- Conditions
- Anesthesia, Local, Needle Phobia
- Keywords
- Needle-free injection, Dental anesthesia, Infiltration, Nerve block
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Randomized split-mouth cross-over clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Needle Infiltration anesthesia | Active comparator | Combination Product: 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-free infiltration anesthesia | Experimental | Combination Product: 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 mental nerve block | Active comparator | Combination Product: 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 mental nerve block | Experimental | Combination Product: 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 | Active comparator | Combination Product: 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 mandibular nerve block | Experimental | Combination Product: 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 infraorbital nerve block | Active comparator | Combination Product: 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). |
| Needle-free infraorbital nerve block | Experimental | Combination Product: 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18-35 years-old
- fluent in English
- cooperate
Key exclusion criteria (3 listed)
- has a history of chronic pain,
- has a systematic disease,
- has root canal therapy at the upper lateral incisor/lower posterior teeth region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meso-Jet, 2% lidocaine(xylocaine)Also: needle-free device, jet injector, NFLJI (Needle-free liquid jet injection system)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 product | Needle-free infiltration anesthesia, Needle-free infraorbital nerve block, Needle-free mandibular nerve block, Needle-free mental nerve block |
| Needle,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. | Combination product | Needle Infiltration anesthesia, Needle infraorbital nerve block, Needle mandibular nerve block, Needle mental nerve block |
Primary outcome
Dental pulp anesthesia
Time frame: 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
Time frame: 10 minutes after injection.
The number of sucessful dental pulp anesthesia cases over total number of participants in the group.
Time to initiation of anesthesia
Time frame: 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
Time frame: 3 hours after injection
Time to termination of anesthesia feeling, measured by a simple pinch test using a periodontal probe
7 secondary outcomes
Baseline pain level
Time frame: 1 minute before injection
Pain level during injection
Time frame: 10 seconds after the injection
Baseline anxiety level
Time frame: 1 minute before injection
Anxiety level during injection
Time frame: 10 seconds after the injection.
Taste preference
Time frame: 1 minute after the injection
Incidence of adverse effect [safety]
Time frame: 10 seconds after injection.
Incidence of adverse effect during follow-up period[safety]
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faleh Tamimi, Ph.D. principal investigator
McGill University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meso-Jet, 2% lidocaine(xylocaine) and Needle,2% lidocaine(xylocaine) in people with Anesthesia, Local and Needle Phobia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental pulp anesthesia (time frame: 10 minutes after injection.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.