<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04493528</url>
  </required_header>
  <id_info>
    <org_study_id>A09-M36-18A</org_study_id>
    <nct_id>NCT04493528</nct_id>
  </id_info>
  <brief_title>Needle-free Dental Anesthesia</brief_title>
  <official_title>Needle-free Dental Anesthesia: a Pilot Split-mouth Cross-over Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many patients experience pain and anxiety from traditional needle anesthesia and may avoid&#xD;
      necessary dental treatments. The needle-free liquid jet injection(NFLJI) could solve these&#xD;
      problems. NFLJI delivers drug solutions by creating a micro-thin pressure liquid jet to&#xD;
      penetrate the skin and disperse in the soft tissue. It has many advantages like eliminating&#xD;
      injection pain, needle phobia and needle disposal. However, anesthesia techniques in&#xD;
      dentistry were all developed for needle injection, and they are not very effective for NFLJI.&#xD;
      Moreover, clinical trials of dental anesthesia using NFLJI have shown inconsistent efficacy.&#xD;
&#xD;
      In this study, we aim to compare the clinical efficacy between NFLJI and needle dental&#xD;
      anesthesia in pilot split-mouth cross-over randomized clinical trials, assess the feasibility&#xD;
      to conduct such trial on a larger scale.&#xD;
&#xD;
      Participants will be assigned to one of the following four groups: 1. Infiltration on a&#xD;
      maxillary lateral incisor,2. Inferior alveolar nerve block, 3.Mental nerve block, 4.&#xD;
      Infraorbital nerve block. Each participant will receive one injection with a needle and&#xD;
      another one with NFLJI randomly at the same appointment. A washout period of 1 hour between&#xD;
      two procedures for participants' to forget the previous experience. Needle injection will be&#xD;
      performed according to clinical standards. NFLJI will be performed according to a guideline&#xD;
      developed in our research group. Participants will stay in the clinic until the anesthesia&#xD;
      effect disappear and be followed for one week.&#xD;
&#xD;
      The primary outcome is the efficacy and effect of two anesthesia interventions. The secondary&#xD;
      outcome is the pain and anxiety visual analogue scale before and during injection, taste&#xD;
      preference, and complications. Additionally, patients' overall feelings for two interventions&#xD;
      as well as any barriers to conducting such a trial will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">July 18, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized split-mouth cross-over clinical trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Dental pulp anesthesia</measure>
    <time_frame>10 minutes after injection.</time_frame>
    <description>Dental pulp anesthesia result is measured by an electric pulp test(EPT), successful anesthesia for dental pulp exhibits an EPT at 80.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of dental pulp anesthesia</measure>
    <time_frame>10 minutes after injection.</time_frame>
    <description>The number of sucessful dental pulp anesthesia cases over total number of participants in the group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to initiation of anesthesia</measure>
    <time_frame>1 minute after injection</time_frame>
    <description>Time to initiation of anesthesia feeling, measured by a simple pinch test using a periodontal probe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to termination of anesthesia</measure>
    <time_frame>3 hours after injection</time_frame>
    <description>Time to termination of anesthesia feeling, measured by a simple pinch test using a periodontal probe</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline pain level</measure>
    <time_frame>1 minute before injection</time_frame>
    <description>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 &quot;no pain&quot;, 10 stands for &quot;worst pain&quot;. Higher score means a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level during injection</measure>
    <time_frame>10 seconds after the injection</time_frame>
    <description>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 &quot;no pain&quot;, 10 stands for &quot;worst pain&quot;. Higher score means a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline anxiety level</measure>
    <time_frame>1 minute before injection</time_frame>
    <description>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 &quot;&quot;Not at all Anxious&quot;, 10 stands for &quot;Extremely Anxious&quot;. Higher score means a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety level during injection</measure>
    <time_frame>10 seconds after the injection.</time_frame>
    <description>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 &quot;&quot;Not at all Anxious&quot;, 10 stands for &quot;Extremely Anxious&quot;. Higher score means a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taste preference</measure>
    <time_frame>1 minute after the injection</time_frame>
    <description>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 &quot;dislike extremely&quot;, 5 stands for &quot;neither like or dislike&quot;, 9 stands for &quot;like extremely&quot;. Higher score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse effect [safety]</measure>
    <time_frame>10 seconds after injection.</time_frame>
    <description>Incidence of adverse effect immediately after aneshesia injection, such as tissue damage, bleeding, hematoma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse effect during follow-up period[safety]</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Incidence of adverse effect after aneshesia procedure during follow-up period, such as: ulcer, hematoma, discomfort, abnormal feeling, nerve damage.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Participant's feedbacks</measure>
    <time_frame>20 minutes after all procedures.</time_frame>
    <description>Reord participants's feedbacks about the whole trial, such as: overall feelings, preferences,complains.</description>
  </other_outcome>
  <other_outcome>
    <measure>Barriers</measure>
    <time_frame>through study completion, from date of recruitment until the date of last follow-up case complition, an average of 6 month.</time_frame>
    <description>Record possible barriesrs in recruitment,randomization,operation.</description>
  </other_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Anesthesia, Local</condition>
  <condition>Needle Phobia</condition>
  <arm_group>
    <arm_group_label>Needle Infiltration anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needle-free infiltration anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needle mental nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needle-free mental nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needle mandibular nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needle-free mandibular nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needle infraorbital nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needle-free infraorbital nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Meso-Jet, 2% lidocaine(xylocaine)</intervention_name>
    <description>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.</description>
    <arm_group_label>Needle-free infiltration anesthesia</arm_group_label>
    <arm_group_label>Needle-free infraorbital nerve block</arm_group_label>
    <arm_group_label>Needle-free mandibular nerve block</arm_group_label>
    <arm_group_label>Needle-free mental nerve block</arm_group_label>
    <other_name>needle-free device</other_name>
    <other_name>jet injector</other_name>
    <other_name>NFLJI (Needle-free liquid jet injection system)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Needle,2% lidocaine(xylocaine)</intervention_name>
    <description>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.</description>
    <arm_group_label>Needle Infiltration anesthesia</arm_group_label>
    <arm_group_label>Needle infraorbital nerve block</arm_group_label>
    <arm_group_label>Needle mandibular nerve block</arm_group_label>
    <arm_group_label>Needle mental nerve block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18-35 years-old&#xD;
&#xD;
          -  fluent in English&#xD;
&#xD;
          -  cooperate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has a history of chronic pain,&#xD;
&#xD;
          -  has a systematic disease,&#xD;
&#xD;
          -  has root canal therapy at the upper lateral incisor/lower posterior teeth region.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faleh Tamimi, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Faculty of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McGill University Faculty of Dentistry</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X1G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>September 2, 2021</last_update_submitted>
  <last_update_submitted_qc>September 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Faleh Tamimi</investigator_full_name>
    <investigator_title>Associate Professor, Accociate Dean</investigator_title>
  </responsible_party>
  <keyword>Needle-free injection</keyword>
  <keyword>Dental anesthesia</keyword>
  <keyword>Infiltration</keyword>
  <keyword>Nerve block</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493528
org study id: A09-M36-18A
nct id: NCT04493528
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized split-mouth cross-over clinical trial.
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.
measure: Dental pulp anesthesia
time frame: 10 minutes after injection.
description: Dental pulp anesthesia result is measured by an electric pulp test(EPT), successful anesthesia for dental pulp exhibits an EPT at 80.
measure: Efficacy of dental pulp anesthesia
time frame: 10 minutes after injection.
description: The number of sucessful dental pulp anesthesia cases over total number of participants in the group.
measure: Time to initiation of anesthesia
time frame: 1 minute after injection
description: Time to initiation of anesthesia feeling, measured by a simple pinch test using a periodontal probe
measure: Time to termination of anesthesia
time frame: 3 hours after injection
description: Time to termination of anesthesia feeling, measured by a simple pinch test using a periodontal probe
measure: Baseline pain level
time frame: 1 minute before injection
description: 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.
measure: Pain level during injection
time frame: 10 seconds after the injection
description: 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.
measure: Baseline anxiety level
time frame: 1 minute before injection
description: 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.
measure: Anxiety level during injection
time frame: 10 seconds after the injection.
description: 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.
measure: Taste preference
time frame: 1 minute after the injection
description: 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.
measure: Incidence of adverse effect [safety]
time frame: 10 seconds after injection.
description: Incidence of adverse effect immediately after aneshesia injection, such as tissue damage, bleeding, hematoma.
measure: Incidence of adverse effect during follow-up period[safety]
time frame: up to 7 days
description: Incidence of adverse effect after aneshesia procedure during follow-up period, such as: ulcer, hematoma, discomfort, abnormal feeling, nerve damage.
measure: Participant's feedbacks
time frame: 20 minutes after all procedures.
description: Reord participants's feedbacks about the whole trial, such as: overall feelings, preferences,complains.
measure: Barriers
time frame: through study completion, from date of recruitment until the date of last follow-up case complition, an average of 6 month.
description: Record possible barriesrs in recruitment,randomization,operation.
arm group label: Needle Infiltration anesthesia
arm group type: Active Comparator
description: 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).
arm group label: Needle-free infiltration anesthesia
arm group type: Experimental
description: 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).
arm group label: Needle mental nerve block
arm group type: Active Comparator
description: 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).
arm group label: Needle-free mental nerve block
arm group type: Experimental
description: 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).
arm group label: Needle mandibular nerve block
arm group type: Active Comparator
description: 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).
arm group label: Needle-free mandibular nerve block
arm group type: Experimental
description: 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).
arm group label: Needle infraorbital nerve block
arm group type: Active Comparator
description: 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).
arm group label: Needle-free infraorbital nerve block
arm group type: Experimental
description: 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).
intervention type: Combination Product
intervention name: Meso-Jet, 2% lidocaine(xylocaine)
description: 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.
arm group label: Needle-free infiltration anesthesia
arm group label: Needle-free infraorbital nerve block
arm group label: Needle-free mandibular nerve block
arm group label: Needle-free mental nerve block
other name: needle-free device
other name: jet injector
other name: NFLJI (Needle-free liquid jet injection system)
intervention type: Combination Product
intervention name: Needle,2% lidocaine(xylocaine)
description: 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.
arm group label: Needle Infiltration anesthesia
arm group label: Needle infraorbital nerve block
arm group label: Needle mandibular nerve block
arm group label: Needle mental nerve block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Faleh Tamimi, Ph.D.
role: Principal Investigator
affiliation: McGill University Faculty of Dentistry
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Faleh Tamimi
investigator title: Associate Professor, Accociate Dean
mesh term: Lidocaine
sharing ipd: No