xml: <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/NCT06001710</url>
    </required_header>
    <id_info>
      <org_study_id>Jet injector anesthesia</org_study_id>
      <nct_id>NCT06001710</nct_id>
    </id_info>
    <brief_title>Assessment of Needleless Jet Injection in Pain and Anxiety Management During Vital Pulpotomy of Primary Molars</brief_title>
    <official_title>Assessment of Needleless Jet Injection in Pain and Anxiety Management During Vital Pulpotomy of Primary Molars</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Suez Canal University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Suez Canal University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate and compare the efficiency of needleless jet injection versus traditional&#xD;
        inferior alveolar nerve block anesthesia in management of pain and anxiety during vital&#xD;
        pulpotomy of lower second primary molars using Wong-Baker FACES Pain Rating Scale and&#xD;
        Venham's anxiety and behavioral rating scale..&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        One of the most effective ways to control pain during invasive dental procedures is the use&#xD;
        of local anesthesia which considers the most painful phase of treatment. The idea of&#xD;
        receiving an injection is fear-inducing for many individuals, both children and adults which&#xD;
        can lead patients to avoid dental treatments. Although such fears are outside the control of&#xD;
        dentists, some treatment aspects can be modified to increase patient comfort.(1)&#xD;
  &#xD;
        Dental care may be associated with pain which may be intertwined with fear and anxiety,&#xD;
        especially among children with treatment needs. The pain intensity is multiplied by having&#xD;
        higher dental anxiety, a disability, age less than 14 years old and gender (female). The&#xD;
        young patient's pain expectations may also add to the situational complexity. Consequently,&#xD;
        dental health care may be perceived as insurmountable problem. (2) Administrating an&#xD;
        anesthetic agent with a traditional syringe causes discomfort during the puncture and&#xD;
        injection stages. (3) Incorrect handling of the syringe is a determining factor for pain (4),&#xD;
        which is exacerbated due to excessive pressure on the plunger and rapid injection of large&#xD;
        volumes of anesthetic solution.(5)&#xD;
  &#xD;
        To minimize the painful sensation during local anesthesia, other methods can be adopted, such&#xD;
        as applying topical anesthetics prior to injection (6), using computerized injection systems,&#xD;
        and using needleless jet injection systems (7). A needleless system includes a spring coupled&#xD;
        to an apparatus that generates sufficient Pressure to (8) push the plunger of the ampoule&#xD;
        (9)and makes the anesthetic solution pass through a micro orifice at high speed.&#xD;
  &#xD;
        The absence of a needle in a jet injection can result in a more comfortable experience, as&#xD;
        this eliminates the puncture and injection phases, which are considered the most painful&#xD;
        steps during traditional anesthesia (3). This difference is important as approximately one in&#xD;
        five adults have phobia of dental anesthesia due to fear of injections, which leads to&#xD;
        interruption of dental treatment (10).&#xD;
  &#xD;
        Since there are no studies about the efficacy of needleless jet injection systems during&#xD;
        pulpotomy of lower second primary molars, the aim of this clinical trial was to evaluate and&#xD;
        compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve&#xD;
        block anesthesia in management of pain and anxiety during vital pulpotomy of lower second&#xD;
        primary molars&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">September 1, 2022</completion_date>
    <primary_completion_date type="Actual">August 1, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Wong-Baker FACES Pain Rating Scale</measure>
      <time_frame>After local anesthesia and during pulpotomy</time_frame>
      <description>a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate &quot;no hurt&quot; to a crying face at 10 to indicate &quot;hurts&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Venham's anxiety and behavioral rating scale</measure>
      <time_frame>After local anesthesia and during pulpotomy</time_frame>
      <description>assess the anxiety and uncooperative behavior of children in the dental setting.consist of five behavioral defined categories ranging from 0 to 5 with higher score, indicating greater level of anxiety or lack of cooperation.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Anesthesia</condition>
    <arm_group>
      <arm_group_label>classic inferior alveolar nerve block anesthesia</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Inferior alveolar nerve block (IANB) is a technique of dental anesthesia, used to produce anesthesia of the mandibular teeth, gingivae of the mandible and lower lip. The conventional IANB is the most commonly used the nerve block technique for achieving local anesthesia for mandibular surgical procedures using long needle</description>
    </arm_group>
    <arm_group>
      <arm_group_label>needleless jet injector anesthesia</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Jet injection technology uses mechanical energy to force a liquid drug into subcutaneous tissues without a needle using infiltration technique</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Needleless jet injector</intervention_name>
      <description>Device consist of injection pen, ampule and activator.</description>
      <arm_group_label>classic inferior alveolar nerve block anesthesia</arm_group_label>
      <arm_group_label>needleless jet injector anesthesia</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Apparently healthy children.&#xD;
  &#xD;
            2. Children aged from 4-8 years old.&#xD;
  &#xD;
            3. Both boys and girls were included&#xD;
  &#xD;
            4. Children scored (2 or 3) Frankle behavior rating scale.&#xD;
  &#xD;
            5. Children had bilateral deep carious lower second primary molars indicated clinically&#xD;
               and radiographically for vital pulpotomy&#xD;
  &#xD;
            6. Informed consent was included from parents or caregivers.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Children with evidence of allergy to any materials used in this study&#xD;
  &#xD;
            2. Clinical criteria:&#xD;
  &#xD;
               Clinical history of spontaneous pain, intra-oral facial swelling or presence of&#xD;
               fistula or sinus tract.&#xD;
  &#xD;
               Tooth with irreversible pulpitis, determined as continuous bleeding exceeding 5&#xD;
               minutes, dark to purple blood color or pulp necrosis.&#xD;
  &#xD;
            3. Radiographic criteria:&#xD;
  &#xD;
          Presence of any signs of internal or external root resorption, furcation radiolucency or&#xD;
          periapical pathosis as revealed by preoperative periapical radiography.&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>8 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of medicine , Suez Canal University</name>
        <address>
          <city>Ismailia</city>
          <zip>41522</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001710
  org study id: Jet injector anesthesia
  nct id: NCT06001710
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate and compare the efficiency of needleless jet injection versus traditional
        inferior alveolar nerve block anesthesia in management of pain and anxiety during vital
        pulpotomy of lower second primary molars using Wong-Baker FACES Pain Rating Scale and
        Venham's anxiety and behavioral rating scale..
  One of the most effective ways to control pain during invasive dental procedures is the use
        of local anesthesia which considers the most painful phase of treatment. The idea of
        receiving an injection is fear-inducing for many individuals, both children and adults which
        can lead patients to avoid dental treatments. Although such fears are outside the control of
        dentists, some treatment aspects can be modified to increase patient comfort.(1)
  
        Dental care may be associated with pain which may be intertwined with fear and anxiety,
        especially among children with treatment needs. The pain intensity is multiplied by having
        higher dental anxiety, a disability, age less than 14 years old and gender (female). The
        young patient's pain expectations may also add to the situational complexity. Consequently,
        dental health care may be perceived as insurmountable problem. (2) Administrating an
        anesthetic agent with a traditional syringe causes discomfort during the puncture and
        injection stages. (3) Incorrect handling of the syringe is a determining factor for pain (4),
        which is exacerbated due to excessive pressure on the plunger and rapid injection of large
        volumes of anesthetic solution.(5)
  
        To minimize the painful sensation during local anesthesia, other methods can be adopted, such
        as applying topical anesthetics prior to injection (6), using computerized injection systems,
        and using needleless jet injection systems (7). A needleless system includes a spring coupled
        to an apparatus that generates sufficient Pressure to (8) push the plunger of the ampoule
        (9)and makes the anesthetic solution pass through a micro orifice at high speed.
  
        The absence of a needle in a jet injection can result in a more comfortable experience, as
        this eliminates the puncture and injection phases, which are considered the most painful
        steps during traditional anesthesia (3). This difference is important as approximately one in
        five adults have phobia of dental anesthesia due to fear of injections, which leads to
        interruption of dental treatment (10).
  
        Since there are no studies about the efficacy of needleless jet injection systems during
        pulpotomy of lower second primary molars, the aim of this clinical trial was to evaluate and
        compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve
        block anesthesia in management of pain and anxiety during vital pulpotomy of lower second
        primary molars
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Wong-Baker FACES Pain Rating Scale
  time frame: After local anesthesia and during pulpotomy
  description: a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts"
  measure: Venham's anxiety and behavioral rating scale
  time frame: After local anesthesia and during pulpotomy
  description: assess the anxiety and uncooperative behavior of children in the dental setting.consist of five behavioral defined categories ranging from 0 to 5 with higher score, indicating greater level of anxiety or lack of cooperation.
  arm group label: classic inferior alveolar nerve block anesthesia
  arm group type: Active Comparator
  description: Inferior alveolar nerve block (IANB) is a technique of dental anesthesia, used to produce anesthesia of the mandibular teeth, gingivae of the mandible and lower lip. The conventional IANB is the most commonly used the nerve block technique for achieving local anesthesia for mandibular surgical procedures using long needle
  arm group label: needleless jet injector anesthesia
  arm group type: Experimental
  description: Jet injection technology uses mechanical energy to force a liquid drug into subcutaneous tissues without a needle using infiltration technique
  intervention type: Device
  intervention name: Needleless jet injector
  description: Device consist of injection pen, ampule and activator.
  arm group label: classic inferior alveolar nerve block anesthesia
  arm group label: needleless jet injector anesthesia
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 8 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Sponsor