xml: <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/NCT06031116</url>
    </required_header>
    <id_info>
      <org_study_id>ceramic v blade depigmentation</org_study_id>
      <nct_id>NCT06031116</nct_id>
    </id_info>
    <brief_title>Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure</brief_title>
    <official_title>Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <has_dmc>Yes</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 investigator compares the clinical outcomes and pain levels after gingival depigmentation&#xD;
        by ceramic soft tissue bur vs scalpel surgery&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This clinical study will be carried out to compare the efficacy of ceramic soft tissue&#xD;
        trimming bur versus the conventional surgical scraping technique in the management of&#xD;
        gingival hyperpigmentation.&#xD;
  &#xD;
        This study will be conducted to assess:&#xD;
  &#xD;
        Primary objectives:&#xD;
  &#xD;
          1. Clinical outcome of the gingival depigmentation procedure.&#xD;
  &#xD;
          2. Assessment of postoperative pain using the visual analogue scale.&#xD;
  &#xD;
          3. Patients' satisfaction will be assessed using the patient satisfaction questionnaire&#xD;
             (short-form, PSQ-18) and the global aesthetic improvement scale.&#xD;
  &#xD;
        Secondary objectives:&#xD;
  &#xD;
          1. Operating time.&#xD;
  &#xD;
          2. Wound healing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 10, 2022</start_date>
    <completion_date type="Actual">May 10, 2023</completion_date>
    <primary_completion_date type="Actual">April 10, 2023</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>
      <intervention_model_description>split mouth (dental arches)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>clinical outcomes of depigmentation procedure</measure>
      <time_frame>3 month postoperative</time_frame>
      <description>dummet oral pigmentation index ( DOPI): 1= pink no pigmentation (better) 4= deep brown (worse) Melanin index (MI):1= isolated pigment (better), 4= long continous ribbon (worse). reported by visual inspection.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>patient satisfaction</measure>
      <time_frame>3 months postoperative</time_frame>
      <description>global aesthetic improvement scale 5 point likert scale 1= excellent improvement 5= worsened. patient reported outcome.&#xD;
  a score from 1 to 5, 1 being better</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percieved pain</measure>
      <time_frame>7 days</time_frame>
      <description>postoperative pain will be assessed using visual analoque scale (VAS): 1= being the least pain and 10= being the most severe</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>operating time</measure>
      <time_frame>during surgery</time_frame>
      <description>time taken from the beginning of the procedure to its end by stopwatch</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wound healing</measure>
      <time_frame>7 days postoperative</time_frame>
      <description>Complete reepithelialization&#xD;
  Incomplete reepithelialization&#xD;
  ulcer&#xD;
  tissue defect or necrosis Dummet 1966</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">8</enrollment>
    <condition>Hyperpigmentation</condition>
    <arm_group>
      <arm_group_label>ceramic soft tissue bur</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Eight dental arches were treated by ceramic soft tissue bur</description>
    </arm_group>
    <arm_group>
      <arm_group_label>scalpel</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Eight dental arches were treated by conventional scalpel technique</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>depigmentation</intervention_name>
      <description>gingival depigmentation</description>
      <arm_group_label>ceramic soft tissue bur</arm_group_label>
      <arm_group_label>scalpel</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males and females within age range of 20-50 years.&#xD;
  &#xD;
            -  Systemic (medically) free individuals.&#xD;
  &#xD;
            -  Gingival pigmentation score &gt; 3 on Hedin melanin index15.&#xD;
  &#xD;
            -  Patients with good oral hygiene.&#xD;
  &#xD;
            -  Patients with thick gingival phenotype.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smokers.&#xD;
  &#xD;
            -  Teeth with compromised periodontium.&#xD;
  &#xD;
            -  Pregnant and lactating females.&#xD;
  &#xD;
            -  The vulnerable group: patients with mental or physical disabilities.&#xD;
  &#xD;
            -  Medications that cause gingival pigmentation.&#xD;
  &#xD;
            -  Pathologies that cause gingival pigmentation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yasmine El sayed, Phd</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hala Abu elela, Phd</last_name>
      <role>Study Chair</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sally Nassar, Bds</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ainshams university</name>
        <address>
          <city>Cairo</city>
          <state>القاهرة</state>
          <zip>11671</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>December 19, 2022</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Sally Nassar</investigator_full_name>
      <investigator_title>Dentist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperpigmentation</mesh_term>
      <mesh_term>Hypopigmentation</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031116
  org study id: ceramic v blade depigmentation
  nct id: NCT06031116
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  the investigator compares the clinical outcomes and pain levels after gingival depigmentation
        by ceramic soft tissue bur vs scalpel surgery
  This clinical study will be carried out to compare the efficacy of ceramic soft tissue
        trimming bur versus the conventional surgical scraping technique in the management of
        gingival hyperpigmentation.
  
        This study will be conducted to assess:
  
        Primary objectives:
  
          1. Clinical outcome of the gingival depigmentation procedure.
  
          2. Assessment of postoperative pain using the visual analogue scale.
  
          3. Patients' satisfaction will be assessed using the patient satisfaction questionnaire
             (short-form, PSQ-18) and the global aesthetic improvement scale.
  
        Secondary objectives:
  
          1. Operating time.
  
          2. Wound healing.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: split mouth (dental arches)
  primary purpose: Treatment
  masking: Single (Participant)
  measure: clinical outcomes of depigmentation procedure
  time frame: 3 month postoperative
  description: dummet oral pigmentation index ( DOPI): 1= pink no pigmentation (better) 4= deep brown (worse) Melanin index (MI):1= isolated pigment (better), 4= long continous ribbon (worse). reported by visual inspection.
  measure: patient satisfaction
  time frame: 3 months postoperative
  description: global aesthetic improvement scale 5 point likert scale 1= excellent improvement 5= worsened. patient reported outcome.
  a score from 1 to 5, 1 being better
  measure: Percieved pain
  time frame: 7 days
  description: postoperative pain will be assessed using visual analoque scale (VAS): 1= being the least pain and 10= being the most severe
  measure: operating time
  time frame: during surgery
  description: time taken from the beginning of the procedure to its end by stopwatch
  measure: Wound healing
  time frame: 7 days postoperative
  description: Complete reepithelialization
  Incomplete reepithelialization
  ulcer
  tissue defect or necrosis Dummet 1966
  arm group label: ceramic soft tissue bur
  arm group type: Experimental
  description: Eight dental arches were treated by ceramic soft tissue bur
  arm group label: scalpel
  arm group type: Active Comparator
  description: Eight dental arches were treated by conventional scalpel technique
  intervention type: Procedure
  intervention name: depigmentation
  description: gingival depigmentation
  arm group label: ceramic soft tissue bur
  arm group label: scalpel
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yasmine El sayed, Phd
  role: Study Director
  affiliation: Ain Shams University
  last name: Hala Abu elela, Phd
  role: Study Chair
  affiliation: Ain Shams University
  last name: Sally Nassar, Bds
  role: Principal Investigator
  affiliation: Ain Shams University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Sally Nassar
  investigator title: Dentist
  mesh term: Hyperpigmentation
  mesh term: Hypopigmentation