<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/NCT03790540</url>
  </required_header>
  <id_info>
    <org_study_id>DentalVibe during LA</org_study_id>
    <nct_id>NCT03790540</nct_id>
  </id_info>
  <brief_title>Pain Assessment During Mandibular Nerve Block Injection With the Aid of Dental Vibe Tool in Pediatric Dental Patients</brief_title>
  <official_title>Pain Assessment During Mandibular Nerve Block Injection With the Aid of Dental Vibe Tool in Pediatric Dental Patients: A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nourhan M.Aly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alexandria</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to valuate the effectiveness of DentalVibe(DV) tool in pain&#xD;
      reduction during local anesthetic injection compared to traditional injection without aid of&#xD;
      DentalVibe in pediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a crossover randomized controlled clinical trial where (N=60 ) children will be&#xD;
      selected from the outpatient clinic of Pediatric Dentistry and Public Health Department,&#xD;
      Faculty of Dentistry, Alexandria University after securing necessary consents. These children&#xD;
      will be selected based on a need for local anesthesia for pulpotomy treatment on both sides&#xD;
      of the mandible. All selected children will be randomly allocated into 2 groups. Group I&#xD;
      (assigned to injection with the aid of DentalVibe tool), Group II(assigned to conventional&#xD;
      injection). Each group will receive 2 mandibular nerve block injections with two different&#xD;
      injection techniques, with 1-2 weeks apart as a washing out period. Mandibular nerve block&#xD;
      injection will be either with vibration using DentalVibe at the injection side or topical&#xD;
      analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at&#xD;
      first the appointment, and the alternative technique will be used at the second appointment .&#xD;
      Injection with the aid of DentalVibe tool will act as the experimental group while the&#xD;
      control group will be the use of topical analgesic (benzocaine 20%).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 10, 2019</primary_completion_date>
  <phase>Phase 2</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>Each group will receive 2 mandibular nerve block injections with two different injection techniques, with 1-2 weeks apart as a washing out period .Mandibular nerve block injection will be either with vibration using DentalVibe at the injection side or topical analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at first the appointment, and the alternative technique will be used at the second appointment. Injection with the aid of DentalVibe tool will act as the experimental group while the control group will be the use of topical analgesic (benzocaine 20%).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The operator will not be blinded to the type of treatment. However, the statistician will be blinded to the treatment groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective pain reduction during local anesthesia administration.</measure>
    <time_frame>during administration of local anesthesia</time_frame>
    <description>Pain will be assessed during local anesthesia injection by means of Wong-Baker faces scale. It consists of faces with different facial expression for happiness and pain and is scored from 0-5 as 0 is very happy and feels no pain and 5 is very painful</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective pain assessment after local anesthesia administration</measure>
    <time_frame>after performing all injections</time_frame>
    <description>After performing all the injections, pain reaction will be evaluated by two investigators independently using recorded video tapes by Face, Leg, Activity, Cry, Consolability Scale (FLACC).&#xD;
The scale comprises the following parameters:&#xD;
(1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0 to 2, which results in a minimum score of 0 and maximum of 10. According to this scale 0 = relaxed and comfortable (no pain), 1-3 = mild discomfort, 4-6 = moderate pain, and 7-10 = severe discomfort or pain, A lower score represents less physical reaction than does a higher number.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Injection with the aid of DentalVibe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mL of Mepivacaine HCl 2%, 1/20000 Levonordefrin will be injected using a 27 gauge dental needle.&#xD;
DentalVibe is a small, handheld cordless device that has a charging docking station. A demonstration of DentalVibe (DV) will be performed by putting it into direct contact with the children's nails before applying the device intraorally. Then, the device will be placed on the oral mucosa to enclose the injection site before administering local anesthesia and Potential subject-expectancy effects and pressure from the placement of DV will be controlled. The device will be turned on to stimulate the area of needle penetration. After 5 seconds of vibration, the needle will be inserted. The device will continue vibrating during needle insertion and anesthetic injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Injection with topical benzocaine 20%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical anesthesia -Benzocaine gel 20%. Tissues will be dried using (2 X 2) gauze to enhance the absorption of the benzocaine gel 20% around the site of the needle penetration and will be left in contact with the soft tissue for one minute. Then the local anesthetic solution (1 ml Mepivacaine HCl 2%, 1/20000 Levonordefrin) will be injected using a 27 gauge dental needle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DentalVibe</intervention_name>
    <description>It is a vibrotactile device that aids in reducing pain during local anesthesia injection in pediatric patients</description>
    <arm_group_label>Injection with the aid of DentalVibe</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical Benzocaine 20%</intervention_name>
    <description>Topical benzocaine 20% gel on the mucosal injection site prior to injection</description>
    <arm_group_label>Injection with topical benzocaine 20%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range from 5-7 years.&#xD;
&#xD;
          -  Patients who are in need of pulpotomy dental treatment requiring bilateral local&#xD;
             anesthesia in the mandible.&#xD;
&#xD;
          -  Children free of any systemic disease or special health care needs.&#xD;
&#xD;
          -  Positive or definitely positive behavior during preoperative assessments according to&#xD;
             the Frankl Scale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having active sites of pathosis in the area of injection that could affect anesthetic&#xD;
             assessment.&#xD;
&#xD;
          -  Signs of irreversible pulpitis or pulp necrosis.&#xD;
&#xD;
          -  Radiographs show periapical or bifurcation radiolucency.&#xD;
&#xD;
          -  Patients allergic to local anesthesia or having a family history of allergy to local&#xD;
             anesthesia.&#xD;
&#xD;
          -  Patients with acute oral or facial infection (swelling and/or cellulitis).&#xD;
&#xD;
          -  Patients refusing to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Passant H Hassanein, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amani M Khalil, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dalia AM Talaat, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry, Alexandria University</name>
      <address>
        <city>Alexandria</city>
        <zip>21512</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Sermet Elbay U, Elbay M, Yildirim S, Kaya E, Kaya C, Ugurluel C, BaydemIr C. Evaluation of the injection pain with the use of DentalVibe injection system during supraperiosteal anaesthesia in children: a randomised clinical trial. Int J Paediatr Dent. 2016 Sep;26(5):336-45. doi: 10.1111/ipd.12204. Epub 2015 Sep 15.</citation>
    <PMID>26369274</PMID>
  </reference>
  <reference>
    <citation>Hutchins HS Jr, Young FA, Lackland DT, Fishburne CP. The effectiveness of topical anesthesia and vibration in alleviating the pain of oral injections. Anesth Prog. 1997 Summer;44(3):87-9.</citation>
    <PMID>9481967</PMID>
  </reference>
  <reference>
    <citation>Ram D, Peretz B. The assessment of pain sensation during local anesthesia using a computerized local anesthesia (Wand) and a conventional syringe. J Dent Child (Chic). 2003 May-Aug;70(2):130-3.</citation>
    <PMID>14528773</PMID>
  </reference>
  <reference>
    <citation>Nanitsos E, Vartuli R, Forte A, Dennison PJ, Peck CC. The effect of vibration on pain during local anaesthesia injections. Aust Dent J. 2009 Jun;54(2):94-100. doi: 10.1111/j.1834-7819.2009.01100.x.</citation>
    <PMID>19473149</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>April 8, 2020</last_update_submitted>
  <last_update_submitted_qc>April 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Nourhan M.Aly</investigator_full_name>
    <investigator_title>Clinical Instructor</investigator_title>
  </responsible_party>
  <keyword>DentalVibe</keyword>
  <keyword>Mandibular nerve block injection</keyword>
  <keyword>Consolability Scale</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Benzocaine</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/NCT03790540
org study id: DentalVibe during LA
nct id: NCT03790540
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The purpose of this study is to valuate the effectiveness of DentalVibe(DV) tool in pain
      reduction during local anesthetic injection compared to traditional injection without aid of
      DentalVibe in pediatric patients.
This study is a crossover randomized controlled clinical trial where (N=60 ) children will be
      selected from the outpatient clinic of Pediatric Dentistry and Public Health Department,
      Faculty of Dentistry, Alexandria University after securing necessary consents. These children
      will be selected based on a need for local anesthesia for pulpotomy treatment on both sides
      of the mandible. All selected children will be randomly allocated into 2 groups. Group I
      (assigned to injection with the aid of DentalVibe tool), Group II(assigned to conventional
      injection). Each group will receive 2 mandibular nerve block injections with two different
      injection techniques, with 1-2 weeks apart as a washing out period. Mandibular nerve block
      injection will be either with vibration using DentalVibe at the injection side or topical
      analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at
      first the appointment, and the alternative technique will be used at the second appointment .
      Injection with the aid of DentalVibe tool will act as the experimental group while the
      control group will be the use of topical analgesic (benzocaine 20%).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Each group will receive 2 mandibular nerve block injections with two different injection techniques, with 1-2 weeks apart as a washing out period .Mandibular nerve block injection will be either with vibration using DentalVibe at the injection side or topical analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at first the appointment, and the alternative technique will be used at the second appointment. Injection with the aid of DentalVibe tool will act as the experimental group while the control group will be the use of topical analgesic (benzocaine 20%).
primary purpose: Other
masking: None (Open Label)
masking description: The operator will not be blinded to the type of treatment. However, the statistician will be blinded to the treatment groups.
measure: Subjective pain reduction during local anesthesia administration.
time frame: during administration of local anesthesia
description: Pain will be assessed during local anesthesia injection by means of Wong-Baker faces scale. It consists of faces with different facial expression for happiness and pain and is scored from 0-5 as 0 is very happy and feels no pain and 5 is very painful
measure: Objective pain assessment after local anesthesia administration
time frame: after performing all injections
description: After performing all the injections, pain reaction will be evaluated by two investigators independently using recorded video tapes by Face, Leg, Activity, Cry, Consolability Scale (FLACC).
The scale comprises the following parameters:
(1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0 to 2, which results in a minimum score of 0 and maximum of 10. According to this scale 0 = relaxed and comfortable (no pain), 1-3 = mild discomfort, 4-6 = moderate pain, and 7-10 = severe discomfort or pain, A lower score represents less physical reaction than does a higher number.
arm group label: Injection with the aid of DentalVibe
arm group type: Experimental
description: 1 mL of Mepivacaine HCl 2%, 1/20000 Levonordefrin will be injected using a 27 gauge dental needle.
DentalVibe is a small, handheld cordless device that has a charging docking station. A demonstration of DentalVibe (DV) will be performed by putting it into direct contact with the children's nails before applying the device intraorally. Then, the device will be placed on the oral mucosa to enclose the injection site before administering local anesthesia and Potential subject-expectancy effects and pressure from the placement of DV will be controlled. The device will be turned on to stimulate the area of needle penetration. After 5 seconds of vibration, the needle will be inserted. The device will continue vibrating during needle insertion and anesthetic injection.
arm group label: Injection with topical benzocaine 20%
arm group type: Active Comparator
description: Topical anesthesia -Benzocaine gel 20%. Tissues will be dried using (2 X 2) gauze to enhance the absorption of the benzocaine gel 20% around the site of the needle penetration and will be left in contact with the soft tissue for one minute. Then the local anesthetic solution (1 ml Mepivacaine HCl 2%, 1/20000 Levonordefrin) will be injected using a 27 gauge dental needle.
intervention type: Device
intervention name: DentalVibe
description: It is a vibrotactile device that aids in reducing pain during local anesthesia injection in pediatric patients
arm group label: Injection with the aid of DentalVibe
intervention type: Drug
intervention name: Topical Benzocaine 20%
description: Topical benzocaine 20% gel on the mucosal injection site prior to injection
arm group label: Injection with topical benzocaine 20%
criteria: 
gender: All
minimum age: 5 Years
maximum age: 7 Years
healthy volunteers: No
last name: Passant H Hassanein, BDS
role: Principal Investigator
affiliation: Alexandria University
last name: Amani M Khalil, PhD
role: Study Director
affiliation: Alexandria University
last name: Dalia AM Talaat, PhD
role: Study Director
affiliation: Alexandria University
facility: 
country: Egypt
citation: Sermet Elbay U, Elbay M, Yildirim S, Kaya E, Kaya C, Ugurluel C, BaydemIr C. Evaluation of the injection pain with the use of DentalVibe injection system during supraperiosteal anaesthesia in children: a randomised clinical trial. Int J Paediatr Dent. 2016 Sep;26(5):336-45. doi: 10.1111/ipd.12204. Epub 2015 Sep 15.
PMID: 26369274
citation: Hutchins HS Jr, Young FA, Lackland DT, Fishburne CP. The effectiveness of topical anesthesia and vibration in alleviating the pain of oral injections. Anesth Prog. 1997 Summer;44(3):87-9.
PMID: 9481967
citation: Ram D, Peretz B. The assessment of pain sensation during local anesthesia using a computerized local anesthesia (Wand) and a conventional syringe. J Dent Child (Chic). 2003 May-Aug;70(2):130-3.
PMID: 14528773
citation: Nanitsos E, Vartuli R, Forte A, Dennison PJ, Peck CC. The effect of vibration on pain during local anaesthesia injections. Aust Dent J. 2009 Jun;54(2):94-100. doi: 10.1111/j.1834-7819.2009.01100.x.
PMID: 19473149
responsible party type: Sponsor-Investigator
investigator affiliation: University of Alexandria
investigator full name: Nourhan M.Aly
investigator title: Clinical Instructor
mesh term: Benzocaine