<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/NCT03839134</url>
  </required_header>
  <id_info>
    <org_study_id>FRP/2018/286</org_study_id>
    <nct_id>NCT03839134</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients</brief_title>
  <official_title>The Effectiveness of Automated Soft Tissue Vibration in Reducing Pain and Accelerating Action of Intraoral Local Anesthesia Injections in Adult Dental Patients. A Randomized Crossover Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riyadh Colleges of Dentistry and Pharmacy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riyadh Colleges of Dentistry and Pharmacy</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 clinical trial will compare pain perception during dental local anesthesia injections&#xD;
      with and without using soft tissue vibration device prior to injection. The primary goal is&#xD;
      to test the effectiveness of such devices in pain/discomfort reduction during intraoral local&#xD;
      anesthesia injections in various techniques (infiltration and block anesthesia).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Actual">September 5, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain of needle penetration of buccal LA injection</measure>
    <time_frame>1-2 seconds after mucosal penetration</time_frame>
    <description>The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain of anesthesia delivery during buccal LA infiltration</measure>
    <time_frame>30 seconds after LA solution delivery</time_frame>
    <description>The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain of needle penetration of palatal LA injection</measure>
    <time_frame>1-2 seconds after mucosal penetration</time_frame>
    <description>The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain of anesthesia delivery during palatal LA infiltration</measure>
    <time_frame>30 seconds after LA solution delivery</time_frame>
    <description>The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain of needle penetration of IAN block LA injection</measure>
    <time_frame>1-2 seconds after mucosal penetration</time_frame>
    <description>The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain of anesthesia delivery during IAN block LA injection</measure>
    <time_frame>30 seconds after LA solution delivery</time_frame>
    <description>The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Anesthetics, Local</condition>
  <arm_group>
    <arm_group_label>Pain of buccal injection with DentalVibe®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) buccal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pain of buccal injection without DentalVibe®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Local anesthesia (LA) for buccal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pain of palatal injection with DentalVibe®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) palatal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pain of palatal injection without DentalVibe®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Local anesthesia (LA) for palatal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pain of block injection with DentalVibe®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) injection for inferior alveolar nerve (IAN) block. The LA to be used is Lidocaine 2% with Epinephrine dental injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pain of block injection without DentalVibe®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Local anesthesia (LA) injection for inferior alveolar nerve (IAN) block using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DentalVibe® Comfort Injection System</intervention_name>
    <description>Soft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection.</description>
    <arm_group_label>Pain of block injection with DentalVibe®</arm_group_label>
    <arm_group_label>Pain of buccal injection with DentalVibe®</arm_group_label>
    <arm_group_label>Pain of palatal injection with DentalVibe®</arm_group_label>
    <other_name>DentalVibe</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Epinephrine</intervention_name>
    <description>Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).</description>
    <arm_group_label>Pain of block injection with DentalVibe®</arm_group_label>
    <arm_group_label>Pain of block injection without DentalVibe®</arm_group_label>
    <arm_group_label>Pain of buccal injection with DentalVibe®</arm_group_label>
    <arm_group_label>Pain of buccal injection without DentalVibe®</arm_group_label>
    <arm_group_label>Pain of palatal injection with DentalVibe®</arm_group_label>
    <arm_group_label>Pain of palatal injection without DentalVibe®</arm_group_label>
    <other_name>Xylocaine 2% with Epinephrine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status class I&#xD;
&#xD;
          -  Planned for multiple dental treatments in the maxilla and mandible bilaterally&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt;18 years old&#xD;
&#xD;
          -  Pregnant ladies&#xD;
&#xD;
          -  Smokers and alcoholics&#xD;
&#xD;
          -  Patients on medications&#xD;
&#xD;
          -  Drug abusers&#xD;
&#xD;
          -  Never received dental treatment under local anesthesia before&#xD;
&#xD;
          -  Patients with an acute infection with or without fever&#xD;
&#xD;
          -  Patients with preoperative pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ra'ed G Salma</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riyadh Elm University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Riyadh Elm University</name>
      <address>
        <city>Riyadh</city>
        <zip>12734</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Riyadh Colleges of Dentistry and Pharmacy</investigator_affiliation>
    <investigator_full_name>Ra'ed Salma</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Epinephryl borate</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/NCT03839134
org study id: FRP/2018/286
nct id: NCT03839134
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The clinical trial will compare pain perception during dental local anesthesia injections
      with and without using soft tissue vibration device prior to injection. The primary goal is
      to test the effectiveness of such devices in pain/discomfort reduction during intraoral local
      anesthesia injections in various techniques (infiltration and block anesthesia).
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Pain of needle penetration of buccal LA injection
time frame: 1-2 seconds after mucosal penetration
description: The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
measure: Pain of anesthesia delivery during buccal LA infiltration
time frame: 30 seconds after LA solution delivery
description: The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
measure: Pain of needle penetration of palatal LA injection
time frame: 1-2 seconds after mucosal penetration
description: The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
measure: Pain of anesthesia delivery during palatal LA infiltration
time frame: 30 seconds after LA solution delivery
description: The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
measure: Pain of needle penetration of IAN block LA injection
time frame: 1-2 seconds after mucosal penetration
description: The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
measure: Pain of anesthesia delivery during IAN block LA injection
time frame: 30 seconds after LA solution delivery
description: The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
arm group label: Pain of buccal injection with DentalVibe®
arm group type: Experimental
description: DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) buccal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.
arm group label: Pain of buccal injection without DentalVibe®
arm group type: Active Comparator
description: Local anesthesia (LA) for buccal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.
arm group label: Pain of palatal injection with DentalVibe®
arm group type: Experimental
description: DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) palatal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.
arm group label: Pain of palatal injection without DentalVibe®
arm group type: Active Comparator
description: Local anesthesia (LA) for palatal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.
arm group label: Pain of block injection with DentalVibe®
arm group type: Experimental
description: DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) injection for inferior alveolar nerve (IAN) block. The LA to be used is Lidocaine 2% with Epinephrine dental injection.
arm group label: Pain of block injection without DentalVibe®
arm group type: Active Comparator
description: Local anesthesia (LA) injection for inferior alveolar nerve (IAN) block using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.
intervention type: Device
intervention name: DentalVibe® Comfort Injection System
description: Soft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection.
arm group label: Pain of block injection with DentalVibe®
arm group label: Pain of buccal injection with DentalVibe®
arm group label: Pain of palatal injection with DentalVibe®
other name: DentalVibe
intervention type: Drug
intervention name: Lidocaine Epinephrine
description: Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
arm group label: Pain of block injection with DentalVibe®
arm group label: Pain of block injection without DentalVibe®
arm group label: Pain of buccal injection with DentalVibe®
arm group label: Pain of buccal injection without DentalVibe®
arm group label: Pain of palatal injection with DentalVibe®
arm group label: Pain of palatal injection without DentalVibe®
other name: Xylocaine 2% with Epinephrine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ra'ed G Salma
role: Principal Investigator
affiliation: Riyadh Elm University
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Riyadh Colleges of Dentistry and Pharmacy
investigator full name: Ra'ed Salma
investigator title: Assistant Professor
mesh term: Lidocaine
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Epinephryl borate
sharing ipd: No