<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/NCT03033628</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2017-01-06</org_study_id>
    <nct_id>NCT03033628</nct_id>
  </id_info>
  <brief_title>Pain Perception of Dental Local Anesthesia Using &quot;DentalVibe Comfort System&quot; in a Group of Egyptian Children</brief_title>
  <official_title>Pain Perception of Maxillary Infiltration Injection of Dental Local Anesthesia Using &quot;DentalVibe Comfort System&quot; Compared to Maxillary Infiltration Injection Alone in a Group of Egyptian Children: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare pain during maxillary infiltration local anesthesia&#xD;
      injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration&#xD;
      injection alone in pediatric dental patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to compare pain during maxillary infiltration local anesthesia&#xD;
      injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration&#xD;
      injection alone.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      History taking from the child and the parent including personal, medical and dental history&#xD;
      as in the examination sheet (Appendix A) to assess inclusion criteria.&#xD;
&#xD;
      Clinical procedure:&#xD;
&#xD;
      Intervention group:&#xD;
&#xD;
      Clinical examination using mirror and probe to assess inclusion criteria. Before initiating&#xD;
      the treatment, the site of the injection will be dried then prepped with antiseptic solution&#xD;
      swab, then a topical anaesthetic agent (topical anesthetics 20% benzocaine) will be applied&#xD;
      with a cotton tip applicator for 60 sec.&#xD;
&#xD;
      Demonstration will be performed by putting the device into direct contact with the children's&#xD;
      nails before applying the device intraorally.&#xD;
&#xD;
      The cheek will be retracted and the device will be turned on.&#xD;
&#xD;
      1mL of local anesthetic solution (articaine hypochloride 4% with 1:100.000 epinephrine,&#xD;
      Septodont) will be injected using a 27 gauge needle which will be delivered over 1 min.&#xD;
&#xD;
      Control group:&#xD;
&#xD;
      AS that of the intervention group except, the device will be used only as a cheek retractor&#xD;
      during the injection, but will be turned off.&#xD;
&#xD;
      Assessment:&#xD;
&#xD;
      Objective assessment will be performed by observing the patients behavior using the FLAAC&#xD;
      scale during the anesthetic injection and needle insertion.&#xD;
&#xD;
      Subjective evaluation will be obtained using the Wong-Baker FACES pain rating scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2017</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain during injection</measure>
    <time_frame>within 1 year</time_frame>
    <description>pain assessment using FLACC behavioral pain assessment (scale 0-10) and Wong-Baker FACES pain rating scale (scale 0-10) e 0: Relaxed and comfortable 1-3: Mild discomfort. 4-6: Moderate pain. 7-10: Severe discomfort or pain or both.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Dental Anxiety</condition>
  <arm_group>
    <arm_group_label>DV group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: injection using DentalVibe comfort system. giving maxillary infiltration dental local anesthesia with the aid of &quot;DentalVibe comfort system&quot; on one side of the maxillary arch prior extraction of primary molar tooth</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: traditional dental injection giving maxillary infiltration dental local anesthesia without the aid of &quot;DentalVibe comfort system&quot; on the other side of the maxillary arch prior extraction of primary molar tooth</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>injection using DentalVibe comfort system</intervention_name>
    <description>giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.</description>
    <arm_group_label>DV group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>traditional dental injection</intervention_name>
    <description>giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.</description>
    <arm_group_label>C group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy children aged 6-7 years old.&#xD;
&#xD;
          2. Apparently healthy Children.&#xD;
&#xD;
          3. Cooperative children.&#xD;
&#xD;
          4. Children with carious maxillary bilateral primary molars indicated for extraction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children who are allergic to amide group.&#xD;
&#xD;
          2. Children with Neurologic disorders.&#xD;
&#xD;
          3. Children with mental disability.&#xD;
&#xD;
          4. Presence of periapical or gingival legion.&#xD;
&#xD;
          5. Severe Gingivitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Norhan El-dokky, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Muaaz Hilal, DR</last_name>
    <phone>00201226090374</phone>
    <email>muaaz09@hotmail.com</email>
  </overall_contact>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>February 14, 2017</last_update_submitted>
  <last_update_submitted_qc>February 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Muaaz Marwan halal</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <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/NCT03033628
org study id: CEBC-CU-2017-01-06
nct id: NCT03033628
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The aim of this study is to compare pain during maxillary infiltration local anesthesia
      injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration
      injection alone in pediatric dental patients.
The aim of this study is to compare pain during maxillary infiltration local anesthesia
      injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration
      injection alone.

      Intervention:

      History taking from the child and the parent including personal, medical and dental history
      as in the examination sheet (Appendix A) to assess inclusion criteria.

      Clinical procedure:

      Intervention group:

      Clinical examination using mirror and probe to assess inclusion criteria. Before initiating
      the treatment, the site of the injection will be dried then prepped with antiseptic solution
      swab, then a topical anaesthetic agent (topical anesthetics 20% benzocaine) will be applied
      with a cotton tip applicator for 60 sec.

      Demonstration will be performed by putting the device into direct contact with the children's
      nails before applying the device intraorally.

      The cheek will be retracted and the device will be turned on.

      1mL of local anesthetic solution (articaine hypochloride 4% with 1:100.000 epinephrine,
      Septodont) will be injected using a 27 gauge needle which will be delivered over 1 min.

      Control group:

      AS that of the intervention group except, the device will be used only as a cheek retractor
      during the injection, but will be turned off.

      Assessment:

      Objective assessment will be performed by observing the patients behavior using the FLAAC
      scale during the anesthetic injection and needle insertion.

      Subjective evaluation will be obtained using the Wong-Baker FACES pain rating scale.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: pain during injection
time frame: within 1 year
description: pain assessment using FLACC behavioral pain assessment (scale 0-10) and Wong-Baker FACES pain rating scale (scale 0-10) e 0: Relaxed and comfortable 1-3: Mild discomfort. 4-6: Moderate pain. 7-10: Severe discomfort or pain or both.
arm group label: DV group
arm group type: Experimental
description: Device: injection using DentalVibe comfort system. giving maxillary infiltration dental local anesthesia with the aid of "DentalVibe comfort system" on one side of the maxillary arch prior extraction of primary molar tooth
arm group label: C group
arm group type: Active Comparator
description: Device: traditional dental injection giving maxillary infiltration dental local anesthesia without the aid of "DentalVibe comfort system" on the other side of the maxillary arch prior extraction of primary molar tooth
intervention type: Device
intervention name: injection using DentalVibe comfort system
description: giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.
arm group label: DV group
intervention type: Device
intervention name: traditional dental injection
description: giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.
arm group label: C group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Norhan El-dokky, PHD
role: Study Director
affiliation: Cairo University
last name: Muaaz Hilal, DR
phone: 00201226090374
email: muaaz09@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Muaaz Marwan halal
investigator title: principal investigator
sharing ipd: No