<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/NCT03261115</url>
  </required_header>
  <id_info>
    <org_study_id>NR3517</org_study_id>
    <nct_id>NCT03261115</nct_id>
  </id_info>
  <brief_title>Effects of Benzocaine 20% Topical Anesthetic and no Topical Agent on Pain Perception During Intra-oral Injections</brief_title>
  <official_title>Efficacy of Topical Benzocaine in Anterior Maxilla: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nurain Rehman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CMH Lahore Medical And Dental College</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 aim of this randomized controlled trial. is to test the efficacy of topical anesthesia&#xD;
      against the use of no topical agent during buccal infiltration in maxillary anterior teeth.&#xD;
      The rationale behind this comparison is to evaluate the practical, clinical outcome of not&#xD;
      using any topical agent if in fact topical anesthesia does not reduce pain as reported by&#xD;
      various studies and if consequently its usage was to be discontinued.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical implication of topical anesthesia and placebo being the same is to not use&#xD;
      either of them prior to LA administration in dentistry. This clinical approach has rarely&#xD;
      been studied and this study aims to compare the effects of the use of topical anesthesia&#xD;
      against the use of no topical agent prior to buccal infiltration in maxillary anterior teeth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">September 20, 2017</completion_date>
  <primary_completion_date type="Actual">September 16, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score on needle penetration</measure>
    <time_frame>Immediately</time_frame>
    <description>Pain score measured by numeric pain rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score on local anesthesia deposition</measure>
    <time_frame>Immediately</time_frame>
    <description>Pain score measured by numeric pain rating scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Topical Anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No topical anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No topical anesthesia</intervention_name>
    <description>Lack of use of topical anesthesia application prior to infiltration injection intra-orally</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above the age of 18&#xD;
&#xD;
          -  Males and females both&#xD;
&#xD;
          -  Participants requiring extraction of maxillary anterior teeth&#xD;
&#xD;
          -  Intact or minimally restored anterior teeth&#xD;
&#xD;
          -  Patients with American Society of Anesthesiologists physical status of 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with physical American Society of Anesthesiologists physical status of 3&#xD;
             or 4&#xD;
&#xD;
          -  Showing signs of inflammation in the area to be injected&#xD;
&#xD;
          -  Having known allergy to any of the agents used in the study&#xD;
&#xD;
          -  Used anti- anxiety drugs or sedatives in the past two weeks&#xD;
&#xD;
          -  Have taken analgesics on the day of data collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nurain Rehman</last_name>
    <role>Principal Investigator</role>
    <affiliation>CMH Lahore Medical College and Institute of Dentistry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samir Qazi, FFDRCSI</last_name>
    <role>Study Director</role>
    <affiliation>CMH Lahore Medical College and Institute of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CMH Lahore Medical College and Institute of Dentistry</name>
      <address>
        <city>Lahore</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>CMH Lahore Medical And Dental College</investigator_affiliation>
    <investigator_full_name>Nurain Rehman</investigator_full_name>
    <investigator_title>Final Year Student BDS</investigator_title>
  </responsible_party>
  <keyword>Pain, Benzocaine, Clinical trial</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT03261115
org study id: NR3517
nct id: NCT03261115
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this randomized controlled trial. is to test the efficacy of topical anesthesia
      against the use of no topical agent during buccal infiltration in maxillary anterior teeth.
      The rationale behind this comparison is to evaluate the practical, clinical outcome of not
      using any topical agent if in fact topical anesthesia does not reduce pain as reported by
      various studies and if consequently its usage was to be discontinued.
The clinical implication of topical anesthesia and placebo being the same is to not use
      either of them prior to LA administration in dentistry. This clinical approach has rarely
      been studied and this study aims to compare the effects of the use of topical anesthesia
      against the use of no topical agent prior to buccal infiltration in maxillary anterior teeth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain score on needle penetration
time frame: Immediately
description: Pain score measured by numeric pain rating scale
measure: Pain score on local anesthesia deposition
time frame: Immediately
description: Pain score measured by numeric pain rating scale
arm group label: Control group
arm group type: No Intervention
description: Topical Anesthesia
arm group label: Study group
arm group type: Experimental
description: No topical anesthesia
intervention type: Procedure
intervention name: No topical anesthesia
description: Lack of use of topical anesthesia application prior to infiltration injection intra-orally
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nurain Rehman
role: Principal Investigator
affiliation: CMH Lahore Medical College and Institute of Dentistry
last name: Samir Qazi, FFDRCSI
role: Study Director
affiliation: CMH Lahore Medical College and Institute of Dentistry
facility: 
country: Pakistan
responsible party type: Sponsor-Investigator
investigator affiliation: CMH Lahore Medical And Dental College
investigator full name: Nurain Rehman
investigator title: Final Year Student BDS
mesh term: Anesthetics
sharing ipd: No