<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/NCT03812965</url>
  </required_header>
  <id_info>
    <org_study_id>80103617.0.0000.5597</org_study_id>
    <nct_id>NCT03812965</nct_id>
  </id_info>
  <brief_title>Botulinum Toxin in the Treatment of Gingival Smile</brief_title>
  <official_title>Effectiveness and Durability of Botulinum Toxin Application in the Treatment of Gingival Smile</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Ibirapuera</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Ibirapuera</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>
      Objective: to evaluate the effect of two gingival smile treatment techniques using botulinum&#xD;
      toxin. Materials and methods: The randomized, double-blind clinical trial (patient and&#xD;
      examiner) will be conducted by two trained and calibrated dentists. Ten patients will be&#xD;
      randomly assigned to each group, in a total of 20 patients with gingiva smile greater than or&#xD;
      equal to 3mm. In group 1, 10 patients will receive 2 units/point of botulinum toxin Botulift®&#xD;
      (botulinum toxin type A), in the muscles form the face: Levators labii superioris alaeque&#xD;
      nasi muscle and Levators labii superioris muscle, totalizing 4 points. In group 2, 2&#xD;
      units/point was injected in the muscles: levators labii superioris alaeque nasi muscle,&#xD;
      totalizing 2 points. The amount of exposed gingiva during smile will be measured using a&#xD;
      pachymeter and the muscle activity of the region will be evaluated through electromyography,&#xD;
      before and after treatment (2, 8, 12, 21 and 25 weeks). Patient satisfaction and discomfort&#xD;
      due to treatment will be evaluated in the same periods through questionnaire. The impact of&#xD;
      the treatment in life quality will be evaluated through OHIP-14 questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">April 8, 2019</completion_date>
  <primary_completion_date type="Actual">February 8, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exposed Gingiva during Smile (mm)</measure>
    <time_frame>Before Treatment</time_frame>
    <description>Measurement of exposed gingiva during smile using a pachymeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exposed Gingiva during Smile (mm)</measure>
    <time_frame>After Treatment (2 weeks)</time_frame>
    <description>Measurement of exposed gingiva during smile using a pachymeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exposed Gingiva during Smile (mm)</measure>
    <time_frame>After Treatment (8 weeks)</time_frame>
    <description>Measurement of exposed gingiva during smile using a pachymeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exposed Gingiva during Smile (mm)</measure>
    <time_frame>After Treatment (12 weeks)</time_frame>
    <description>Measurement of exposed gingiva during smile using a pachymeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exposed Gingiva during Smile (mm)</measure>
    <time_frame>After Treatment (21 weeks)</time_frame>
    <description>Measurement of exposed gingiva during smile using a pachymeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exposed Gingiva during Smile (mm)</measure>
    <time_frame>After Treatment (25 weeks)</time_frame>
    <description>Measurement of exposed gingiva during smile using a pachymeter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscles Activity</measure>
    <time_frame>Before Treatment</time_frame>
    <description>Muscles activity using electromyography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscles Activity</measure>
    <time_frame>After Treatment (2 weeks)</time_frame>
    <description>Muscles activity using electromyography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscles Activity</measure>
    <time_frame>After Treatment (8 weeks)</time_frame>
    <description>Muscles activity using electromyography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscles Activity</measure>
    <time_frame>After Treatment (12 weeks)</time_frame>
    <description>Muscles activity using electromyography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscles Activity</measure>
    <time_frame>After Treatment (21 weeks)</time_frame>
    <description>Muscles activity using electromyography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscles Activity</measure>
    <time_frame>After Treatment (25 weeks)</time_frame>
    <description>Muscles activity using electromyography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Smiling</condition>
  <arm_group>
    <arm_group_label>Group 1 - Botulinum Toxin type A (4 points of application)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle and Levators labii superioris muscle (n=10 Patients)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - - Botulinum Toxin type A (2 points of application)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle (n=10 Patients)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin type A</intervention_name>
    <description>2 units/point of botulinum toxin type A</description>
    <arm_group_label>Group 1 - Botulinum Toxin type A (4 points of application)</arm_group_label>
    <arm_group_label>Group 2 - - Botulinum Toxin type A (2 points of application)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of both genders exhibiting gingival exposure greater than or equal to 3 mm&#xD;
             above the central incisor during smile&#xD;
&#xD;
          2. Patients with good general health and good oral hygiene.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with Botulinum Toxin allergy or albumin, or who have previously performed&#xD;
             botulinum toxin facial treatment previously.&#xD;
&#xD;
          2. Patients with Amyotrophic Lateral Sclerosis, Neuropathy, Myasthenia Gravis or&#xD;
             Lambert-Eaton Syndrome, women who are pregnant or planning to become pregnant, are&#xD;
             breastfeeding women.&#xD;
&#xD;
          3. Patients who are participating in other research involving other drugs.&#xD;
&#xD;
          4. Patients who use drugs that interfere with neuromuscular transmission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aline B Costa, DDS</last_name>
    <role>Study Chair</role>
    <affiliation>Ibirapuera University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dinete Romansina, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juliana Ramalho, DDS</last_name>
    <role>Study Chair</role>
    <affiliation>Ibirapuera University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karen M Ramalho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ibirapuera University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susana Morimoto, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Ibirapuera University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Ibirapuera</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>04661-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>June 4, 2019</last_update_submitted>
  <last_update_submitted_qc>June 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Ibirapuera</investigator_affiliation>
    <investigator_full_name>Karen Müller Ramalho</investigator_full_name>
    <investigator_title>Full Professor</investigator_title>
  </responsible_party>
  <keyword>Botulinum Toxin</keyword>
  <keyword>Gingival Smile</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03812965
org study id: 80103617.0.0000.5597
nct id: NCT03812965
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: to evaluate the effect of two gingival smile treatment techniques using botulinum
      toxin. Materials and methods: The randomized, double-blind clinical trial (patient and
      examiner) will be conducted by two trained and calibrated dentists. Ten patients will be
      randomly assigned to each group, in a total of 20 patients with gingiva smile greater than or
      equal to 3mm. In group 1, 10 patients will receive 2 units/point of botulinum toxin Botulift®
      (botulinum toxin type A), in the muscles form the face: Levators labii superioris alaeque
      nasi muscle and Levators labii superioris muscle, totalizing 4 points. In group 2, 2
      units/point was injected in the muscles: levators labii superioris alaeque nasi muscle,
      totalizing 2 points. The amount of exposed gingiva during smile will be measured using a
      pachymeter and the muscle activity of the region will be evaluated through electromyography,
      before and after treatment (2, 8, 12, 21 and 25 weeks). Patient satisfaction and discomfort
      due to treatment will be evaluated in the same periods through questionnaire. The impact of
      the treatment in life quality will be evaluated through OHIP-14 questionnaire.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Exposed Gingiva during Smile (mm)
time frame: Before Treatment
description: Measurement of exposed gingiva during smile using a pachymeter
measure: Exposed Gingiva during Smile (mm)
time frame: After Treatment (2 weeks)
description: Measurement of exposed gingiva during smile using a pachymeter
measure: Exposed Gingiva during Smile (mm)
time frame: After Treatment (8 weeks)
description: Measurement of exposed gingiva during smile using a pachymeter
measure: Exposed Gingiva during Smile (mm)
time frame: After Treatment (12 weeks)
description: Measurement of exposed gingiva during smile using a pachymeter
measure: Exposed Gingiva during Smile (mm)
time frame: After Treatment (21 weeks)
description: Measurement of exposed gingiva during smile using a pachymeter
measure: Exposed Gingiva during Smile (mm)
time frame: After Treatment (25 weeks)
description: Measurement of exposed gingiva during smile using a pachymeter
measure: Muscles Activity
time frame: Before Treatment
description: Muscles activity using electromyography
measure: Muscles Activity
time frame: After Treatment (2 weeks)
description: Muscles activity using electromyography
measure: Muscles Activity
time frame: After Treatment (8 weeks)
description: Muscles activity using electromyography
measure: Muscles Activity
time frame: After Treatment (12 weeks)
description: Muscles activity using electromyography
measure: Muscles Activity
time frame: After Treatment (21 weeks)
description: Muscles activity using electromyography
measure: Muscles Activity
time frame: After Treatment (25 weeks)
description: Muscles activity using electromyography
arm group label: Group 1 - Botulinum Toxin type A (4 points of application)
arm group type: Experimental
description: 4 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle and Levators labii superioris muscle (n=10 Patients)
arm group label: Group 2 - - Botulinum Toxin type A (2 points of application)
arm group type: Experimental
description: 2 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle (n=10 Patients)
intervention type: Drug
intervention name: Botulinum toxin type A
description: 2 units/point of botulinum toxin type A
arm group label: Group 1 - Botulinum Toxin type A (4 points of application)
arm group label: Group 2 - - Botulinum Toxin type A (2 points of application)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aline B Costa, DDS
role: Study Chair
affiliation: Ibirapuera University
last name: Dinete Romansina, MSc
role: Study Chair
affiliation: University of São Paulo
last name: Juliana Ramalho, DDS
role: Study Chair
affiliation: Ibirapuera University
last name: Karen M Ramalho, PhD
role: Principal Investigator
affiliation: Ibirapuera University
last name: Susana Morimoto, PhD
role: Study Chair
affiliation: Ibirapuera University
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Ibirapuera
investigator full name: Karen Müller Ramalho
investigator title: Full Professor
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: Undecided