<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/NCT03802305</url>
  </required_header>
  <id_info>
    <org_study_id>RC18_0268</org_study_id>
    <nct_id>NCT03802305</nct_id>
  </id_info>
  <brief_title>Comparison of Osteocentral Versus Locoregional Anesthesia in Case of Mandibular Molar Pulpitis</brief_title>
  <acronym>COQ</acronym>
  <official_title>Comparison of the Variations of the Cardiovascular Parameters and the Efficiency of the Osteocentral Anesthesia (Quicksleeper™) and the Locoregional Anesthesia in the Case of Mandibular Pulpitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The irreversible acute pulpitis is the most common emergency at the hospital during dental&#xD;
      consultation. Pulpitis are characterized by intense and spontaneous oro-facial pains. In case&#xD;
      of mandibular molar, the emergency treatment consists in realizing a pulpotomy (eviction of&#xD;
      cameral pulp) under locoregional anesthesia called inferior alveolar nerve block (IANB). The&#xD;
      latter represents a real challenge, since inflammation may decrease its action. To mitigate&#xD;
      this deficiency and the drawbacks of the IANB (onset and duration of the anesthesia, bites&#xD;
      risk reported with IANB) other anesthesias are proposed. In particular the computerized&#xD;
      intraosseous technique anesthesia of which the Quicksleeper™ system is a part. However,&#xD;
      according to the observers, a mild to severe tachycardia have been reported.&#xD;
&#xD;
      Very few valid clinical trials exists on the subject, most being realized with systems of&#xD;
      intraosseous anesthesia other than Quicksleeper™. Therefore, the aim of this study is first&#xD;
      to analyze the variations of the cardiovascular parameters into two groups of anesthesia:&#xD;
      locoregional anesthesia and Quicksleeper ™ system; and then, to compare the efficiency, side&#xD;
      effects, operating consequences of both techniques. This study should provide better data&#xD;
      about potential risk with computerized intraosseous technique such has Quicksleeper ™ system&#xD;
      in healthy or cardiovascular risk patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When the patient arrive in the dental care center, an initial assessment is made to get the&#xD;
      diagnosis of irreversible pulpitis:&#xD;
&#xD;
        1. Anamnesis:&#xD;
&#xD;
           acute and spontaneous oro-facial pain, pulsatile severe intensity, which could irradiate&#xD;
           toward the ear and/or jaw, exacerbated by cold or hot.&#xD;
&#xD;
        2. Clinical exams: positive vitality tests (electric test and cold pressor test)&#xD;
&#xD;
        3. Further examination (radiography)&#xD;
&#xD;
      The inclusion and exclusion criteria will be checked and the informed consent of the patient&#xD;
      will be taken. The patient is then randomized in one of the group (experimental or control).&#xD;
      He will fill a questionnaire (Corah's scale) for evaluating his state of anxiety during care.&#xD;
      A monitoring of cardiac parameters is made during the care at defined moment.&#xD;
&#xD;
      The patient evaluates his pain himself with the VAS (Visual Analog Score), before the&#xD;
      intervention. The anesthesia is carried out by only one experimenter, with the Quickslepper™&#xD;
      handpiece but different specific needles.&#xD;
&#xD;
      Each patient receive 1.8 mL of 4% articaine 1:100 000 on a period of 2 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">June 17, 2022</completion_date>
  <primary_completion_date type="Actual">June 17, 2022</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Number of Arms: 2 Masking: Simple Blinded, Masked Roles: Subject Allocation: Randomized Study Endpoint Classification: Interventional Research with Minimal Risk and Constraints, Safety/Efficacy Enrollment: subjects (anticipated)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event.</measure>
    <time_frame>at day 0, from T0 minute to T14 minutes</time_frame>
    <description>3 successive values of heart rate similar to those registered before injection.&#xD;
3 successive values of blood pressure (diastolic and systolic) similar to those registered before injection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare the pain of the patient between the two anesthetic techniques</measure>
    <time_frame>3 days</time_frame>
    <description>Scores measured with Visual Analog Score( Heft-Parker's pain assessment) (minimum score : no pain ; maximal score : maximum pain unimaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the possible postoperative course between the 2 anesthetic techniques</measure>
    <time_frame>3 days</time_frame>
    <description>The postoperative course will be evaluated using a post-operative table to be completed by the patient at Day + 1, Day + 2 and Day + 3. Collection of information by phone call to the patient. The presence or absence of the following item is measured : pain after waking up, swelling, hematoma, seepage, higher tooth sensation, bite, possibility of feeding, mouth opening limitation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Endodontic Inflammation</condition>
  <arm_group>
    <arm_group_label>Computerized intraosseous technique (Quicksleeper™)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive the anesthetic solution with computerized intraosseous technique anesthesia near the tooth roots involved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>loco-regional anesthesia (IANB technique)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive the anesthetic solution with the loco-regional anesthesia technique: near the place where the nerve goes into the jaw, based on osteo muscular markers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>computerized intraosseous technique (Quicksleeper™)</intervention_name>
    <description>The anesthetic solution is administered with a specific equipment allowing the injection step by step:&#xD;
anesthesia of the interdental papilla,&#xD;
positioning of the needle and perforating of the interdental space,&#xD;
Injection of the solution. All of these steps are based on an adjustment of the different part of this equipment.</description>
    <arm_group_label>Computerized intraosseous technique (Quicksleeper™)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>loco-regional anesthesia (IANB technique)</intervention_name>
    <description>The anesthetic solution is delivered by a needle near to the inferior alveolar nerve before it enters the mandibular foramen.</description>
    <arm_group_label>loco-regional anesthesia (IANB technique)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  real irreversible pulpitis of a mandibular molar in dental emergency consultation at&#xD;
             the Nantes hospital&#xD;
&#xD;
          -  Healthy patient without medical history (ASA 1), without treatment for heart rate&#xD;
             distress (anti arrhythmic, beta-blocking drug)&#xD;
&#xD;
          -  Major and covered by the social security&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA &gt; 1&#xD;
&#xD;
          -  Pregnant and breastfeeding women&#xD;
&#xD;
          -  Minors&#xD;
&#xD;
          -  Adults under guardianships&#xD;
&#xD;
          -  Adults deprived of freedom&#xD;
&#xD;
          -  Impossibility to obtain for informed consent&#xD;
&#xD;
          -  Allergy to anesthetic components&#xD;
&#xD;
          -  Contraindication of vasoconstrictor&#xD;
&#xD;
          -  Angle closure glaucoma&#xD;
&#xD;
               -  Pheochromocytomas&#xD;
&#xD;
               -  Bisphosphonate IV&#xD;
&#xD;
               -  Irradiated patient (upper respiratory and gastrointestinal tract cancer)&#xD;
&#xD;
               -  Contraindication with Mono-amino oxidase inhibitors&#xD;
&#xD;
          -  Acute apical periodontitis&#xD;
&#xD;
          -  Pulpitis on wisdom teeth&#xD;
&#xD;
          -  Vital teeth with fixed prosthesis&#xD;
&#xD;
          -  Active periodontal disease&#xD;
&#xD;
          -  Local anatomic difficulty&#xD;
&#xD;
          -  No reference tooth for vitality dental test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nantes Universitary Hospital</name>
      <address>
        <city>Nantes</city>
        <state>Loire-Atlantique</state>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>June 27, 2022</last_update_submitted>
  <last_update_submitted_qc>June 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulpitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03802305
org study id: RC18_0268
nct id: NCT03802305
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The irreversible acute pulpitis is the most common emergency at the hospital during dental
      consultation. Pulpitis are characterized by intense and spontaneous oro-facial pains. In case
      of mandibular molar, the emergency treatment consists in realizing a pulpotomy (eviction of
      cameral pulp) under locoregional anesthesia called inferior alveolar nerve block (IANB). The
      latter represents a real challenge, since inflammation may decrease its action. To mitigate
      this deficiency and the drawbacks of the IANB (onset and duration of the anesthesia, bites
      risk reported with IANB) other anesthesias are proposed. In particular the computerized
      intraosseous technique anesthesia of which the Quicksleeper™ system is a part. However,
      according to the observers, a mild to severe tachycardia have been reported.

      Very few valid clinical trials exists on the subject, most being realized with systems of
      intraosseous anesthesia other than Quicksleeper™. Therefore, the aim of this study is first
      to analyze the variations of the cardiovascular parameters into two groups of anesthesia:
      locoregional anesthesia and Quicksleeper ™ system; and then, to compare the efficiency, side
      effects, operating consequences of both techniques. This study should provide better data
      about potential risk with computerized intraosseous technique such has Quicksleeper ™ system
      in healthy or cardiovascular risk patient.
When the patient arrive in the dental care center, an initial assessment is made to get the
      diagnosis of irreversible pulpitis:

        1. Anamnesis:

           acute and spontaneous oro-facial pain, pulsatile severe intensity, which could irradiate
           toward the ear and/or jaw, exacerbated by cold or hot.

        2. Clinical exams: positive vitality tests (electric test and cold pressor test)

        3. Further examination (radiography)

      The inclusion and exclusion criteria will be checked and the informed consent of the patient
      will be taken. The patient is then randomized in one of the group (experimental or control).
      He will fill a questionnaire (Corah's scale) for evaluating his state of anxiety during care.
      A monitoring of cardiac parameters is made during the care at defined moment.

      The patient evaluates his pain himself with the VAS (Visual Analog Score), before the
      intervention. The anesthesia is carried out by only one experimenter, with the Quickslepper™
      handpiece but different specific needles.

      Each patient receive 1.8 mL of 4% articaine 1:100 000 on a period of 2 minutes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Number of Arms: 2 Masking: Simple Blinded, Masked Roles: Subject Allocation: Randomized Study Endpoint Classification: Interventional Research with Minimal Risk and Constraints, Safety/Efficacy Enrollment: subjects (anticipated)
primary purpose: Treatment
masking: Single (Participant)
measure: time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event.
time frame: at day 0, from T0 minute to T14 minutes
description: 3 successive values of heart rate similar to those registered before injection.
3 successive values of blood pressure (diastolic and systolic) similar to those registered before injection.
measure: Compare the pain of the patient between the two anesthetic techniques
time frame: 3 days
description: Scores measured with Visual Analog Score( Heft-Parker's pain assessment) (minimum score : no pain ; maximal score : maximum pain unimaginable)
measure: Compare the possible postoperative course between the 2 anesthetic techniques
time frame: 3 days
description: The postoperative course will be evaluated using a post-operative table to be completed by the patient at Day + 1, Day + 2 and Day + 3. Collection of information by phone call to the patient. The presence or absence of the following item is measured : pain after waking up, swelling, hematoma, seepage, higher tooth sensation, bite, possibility of feeding, mouth opening limitation.
arm group label: Computerized intraosseous technique (Quicksleeper™)
arm group type: Experimental
description: patients will receive the anesthetic solution with computerized intraosseous technique anesthesia near the tooth roots involved.
arm group label: loco-regional anesthesia (IANB technique)
arm group type: Active Comparator
description: patients will receive the anesthetic solution with the loco-regional anesthesia technique: near the place where the nerve goes into the jaw, based on osteo muscular markers.
intervention type: Device
intervention name: computerized intraosseous technique (Quicksleeper™)
description: The anesthetic solution is administered with a specific equipment allowing the injection step by step:
anesthesia of the interdental papilla,
positioning of the needle and perforating of the interdental space,
Injection of the solution. All of these steps are based on an adjustment of the different part of this equipment.
arm group label: Computerized intraosseous technique (Quicksleeper™)
intervention type: Device
intervention name: loco-regional anesthesia (IANB technique)
description: The anesthetic solution is delivered by a needle near to the inferior alveolar nerve before it enters the mandibular foramen.
arm group label: loco-regional anesthesia (IANB technique)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Pulpitis
mesh term: Inflammation
mesh term: Anesthetics