<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/NCT03827122</url>
  </required_header>
  <id_info>
    <org_study_id>RC/IRB/2018/1247</org_study_id>
    <nct_id>NCT03827122</nct_id>
  </id_info>
  <brief_title>Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study</brief_title>
  <official_title>Botulinum Toxin A Injectable Solution in the Management of Bruxism</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>Yes</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>
      A Clinical Trial Study to investigate the potential performance of BTXA on masseter muscle on&#xD;
      patient with nocturnal bruxism and to check the pain scale and share this clinical&#xD;
      experience.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental group we will use BTX-A administration group. All patients (Male/Female) with&#xD;
      bruxism associated with chronic pain in masseter muscles bilaterally participated in this&#xD;
      study. The patients age 18-60 years. According to the diagnostic grading system of bruxism&#xD;
      all subjects will have an assessment including a bruxism questionnaire (i.e., oral history&#xD;
      taking with specific focus on bruxism habits) plus a clinical examination to evaluate bruxism&#xD;
      signs and symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 13, 2018</start_date>
  <completion_date type="Anticipated">November 13, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 11, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single group with bruxism they will be injected in masster muscles bilaterally</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain reduction after botox injection subjective</measure>
    <time_frame>Change in clenching after 2,8,16,48 weeks</time_frame>
    <description>Visual pain scale with a score from 0 to 10</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Nocturnal Bruxism</condition>
  <arm_group>
    <arm_group_label>Group one</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Botx will be injection in masster muscles 20unit Botx (onabotulinumtoxinA) and visual pain scale will be taken before and after in four intervals 2,8,16,48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>onabotulinumtoxinA</intervention_name>
    <description>Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally Patients will have treatment with 20 units of BOTOX, (Allergan Inc.) per side will be injected at three points into masseter muscle bilaterally.</description>
    <arm_group_label>Group one</arm_group_label>
    <other_name>Botox Allergan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Moderate to severe pain in relation to the masseter muscles and TMJ area related to&#xD;
             bruxism during clinical examination.&#xD;
&#xD;
          2. Aged 20-60 patients.&#xD;
&#xD;
          3. Tooth-grinding sounds corroborated by family members or caregivers.&#xD;
&#xD;
          4. Cases where bruxism resulted in occlusal surface attrition of posterior teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. pain in the orofacial region,&#xD;
&#xD;
          2. insomnia,&#xD;
&#xD;
          3. known botulinum toxin allergy,&#xD;
&#xD;
          4. pregnancy,&#xD;
&#xD;
          5. neuromuscular disease,&#xD;
&#xD;
          6. bleeding disorders,&#xD;
&#xD;
          7. antibiotic therapy,&#xD;
&#xD;
          8. pulmonary disease that produced coughing during sleep,&#xD;
&#xD;
          9. infectious skin lesion at the site of the injection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baraa abdulrahman, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riyadh Colleges of Dentistry and Pharmacy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Baraa abdulrahman, BDS</last_name>
    <phone>+966582766220</phone>
    <email>Baraa.abdulrahman@riyadh.edu.sa</email>
  </overall_contact>
  <location>
    <facility>
      <name>Riyadh Elm University</name>
      <address>
        <city>Riyadh</city>
        <zip>11681</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Baraa abdulrahman</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 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>Baraa Abdulrahman</investigator_full_name>
    <investigator_title>Master Resident in Oral Diagnostics</investigator_title>
  </responsible_party>
  <keyword>Bruxism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bruxism</mesh_term>
    <mesh_term>Sleep Bruxism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</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/NCT03827122
org study id: RC/IRB/2018/1247
nct id: NCT03827122
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A Clinical Trial Study to investigate the potential performance of BTXA on masseter muscle on
      patient with nocturnal bruxism and to check the pain scale and share this clinical
      experience.
Experimental group we will use BTX-A administration group. All patients (Male/Female) with
      bruxism associated with chronic pain in masseter muscles bilaterally participated in this
      study. The patients age 18-60 years. According to the diagnostic grading system of bruxism
      all subjects will have an assessment including a bruxism questionnaire (i.e., oral history
      taking with specific focus on bruxism habits) plus a clinical examination to evaluate bruxism
      signs and symptoms.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group with bruxism they will be injected in masster muscles bilaterally
primary purpose: Treatment
masking: None (Open Label)
measure: Pain reduction after botox injection subjective
time frame: Change in clenching after 2,8,16,48 weeks
description: Visual pain scale with a score from 0 to 10
arm group label: Group one
arm group type: Experimental
description: Botx will be injection in masster muscles 20unit Botx (onabotulinumtoxinA) and visual pain scale will be taken before and after in four intervals 2,8,16,48 weeks
intervention type: Drug
intervention name: onabotulinumtoxinA
description: Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally Patients will have treatment with 20 units of BOTOX, (Allergan Inc.) per side will be injected at three points into masseter muscle bilaterally.
arm group label: Group one
other name: Botox Allergan
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Baraa abdulrahman, BDS
role: Principal Investigator
affiliation: Riyadh Colleges of Dentistry and Pharmacy
last name: Baraa abdulrahman, BDS
phone: +966582766220
email: Baraa.abdulrahman@riyadh.edu.sa
facility: 
status: Recruiting
contact: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Riyadh Colleges of Dentistry and Pharmacy
investigator full name: Baraa Abdulrahman
investigator title: Master Resident in Oral Diagnostics
mesh term: Bruxism
mesh term: Sleep Bruxism
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No