<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/NCT04482790</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2019-8-23</org_study_id>
    <nct_id>NCT04482790</nct_id>
  </id_info>
  <brief_title>Restoring Black Triangle With Bioclear Matrix Versus Celluloid Conventional Matrix Method</brief_title>
  <acronym>RBBCM</acronym>
  <official_title>Restoring Black Triangle With Bioclear Matrix and Injection Molding Technique Versus Celluloid Conventional Matrix Method: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Assessment of bioclear matrix and injection molding technique against conventional celluloid&#xD;
      matrix technique in management of black triangle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with black triangle defect in anterior teeth (Cl I and Cl II according to Nordland&#xD;
      and Tarnow classification) managed by Bioclear matrix with injection molding technique and&#xD;
      conventional celluloid matrix technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Esthetic evaluation</measure>
    <time_frame>12 months</time_frame>
    <description>Scoring system according to World Dental Federation (FDI) criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Marginal adaptation</measure>
    <time_frame>12 months</time_frame>
    <description>Scoring system according to FDI criteria from one to five one represents very good clinically restoration &amp; five represents poor clinically restoration</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Phonetics</measure>
    <time_frame>12 months</time_frame>
    <description>Visual Analogue Scale (VAS) from zero to ten ,zero represents none &amp; ten represent sever</description>
  </other_outcome>
  <other_outcome>
    <measure>Food impaction</measure>
    <time_frame>12 months</time_frame>
    <description>Visual Analogue Scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Gingival Black Triangle</condition>
  <arm_group>
    <arm_group_label>Conventional celluloid matrix</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional celluloid matrix technique in management of black triangle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bioclear cervical matrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bioclear cervical matrix with injection molding technique in management of black triangle</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional celluloid matrix technique in management of black triangle</intervention_name>
    <description>conventional restorative technique in management of black triangle</description>
    <arm_group_label>Conventional celluloid matrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bioclear cervical matrix with injection molding technique</intervention_name>
    <description>New restorative technique in management of black triangle restorative papilla regeneration</description>
    <arm_group_label>Bioclear cervical matrix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients eligible for the trial must comply with all of the following:&#xD;
&#xD;
               -  Cl I and cl II according to Nordland and Tarnow classification&#xD;
&#xD;
               -  Good oral hygiene&#xD;
&#xD;
               -  Good general health&#xD;
&#xD;
               -  Cooperative patient&#xD;
&#xD;
               -  Subjects who signed the informed consent&#xD;
&#xD;
               -  Patient compliance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cl III according to Nordland and Tarnow classification&#xD;
&#xD;
          -  Uncontrolled parafunction.&#xD;
&#xD;
          -  Insufficient oral hygiene&#xD;
&#xD;
          -  Periodontal and gingival diseases&#xD;
&#xD;
          -  Pregnant and nursing&#xD;
&#xD;
          -  Disabilities&#xD;
&#xD;
          -  Systemic disease or severe medical complications&#xD;
&#xD;
          -  Lack of compliance&#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>Aya O Hussien, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aya Omar Hussien, MD</last_name>
    <phone>01002877503</phone>
    <phone_ext>002</phone_ext>
    <email>ayaomar8846@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>shereen H Ibrahim, A.professor</last_name>
    <phone>01099296591</phone>
    <phone_ext>002</phone_ext>
    <email>shereen.hafez@dentistry.cu.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Dentistry, Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>11553</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aya Omar Tawfik, MD</last_name>
      <phone>01002877503</phone>
      <phone_ext>002</phone_ext>
      <email>ayaomar8846@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Shereen H Ibrahim, A.professor</last_name>
      <phone>01099296591</phone>
      <phone_ext>002</phone_ext>
      <email>shereen.hafez@dentistry.cu.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Aya Omar Tawfik Hussien</investigator_full_name>
    <investigator_title>Assistant lecturer in conservative department of faculty of dentistry</investigator_title>
  </responsible_party>
  <keyword>black triangle</keyword>
  <keyword>bio-clear cervical matrix</keyword>
  <keyword>dental esthetics</keyword>
  <!-- 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/NCT04482790
org study id: CEBD-CU-2019-8-23
nct id: NCT04482790
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Assessment of bioclear matrix and injection molding technique against conventional celluloid
      matrix technique in management of black triangle.
Patients with black triangle defect in anterior teeth (Cl I and Cl II according to Nordland
      and Tarnow classification) managed by Bioclear matrix with injection molding technique and
      conventional celluloid matrix technique.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Esthetic evaluation
time frame: 12 months
description: Scoring system according to World Dental Federation (FDI) criteria
measure: Marginal adaptation
time frame: 12 months
description: Scoring system according to FDI criteria from one to five one represents very good clinically restoration & five represents poor clinically restoration
measure: Phonetics
time frame: 12 months
description: Visual Analogue Scale (VAS) from zero to ten ,zero represents none & ten represent sever
measure: Food impaction
time frame: 12 months
description: Visual Analogue Scale
arm group label: Conventional celluloid matrix
arm group type: Active Comparator
description: Conventional celluloid matrix technique in management of black triangle
arm group label: Bioclear cervical matrix
arm group type: Experimental
description: Bioclear cervical matrix with injection molding technique in management of black triangle
intervention type: Procedure
intervention name: Conventional celluloid matrix technique in management of black triangle
description: conventional restorative technique in management of black triangle
arm group label: Conventional celluloid matrix
intervention type: Procedure
intervention name: Bioclear cervical matrix with injection molding technique
description: New restorative technique in management of black triangle restorative papilla regeneration
arm group label: Bioclear cervical matrix
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aya O Hussien, MD
role: Principal Investigator
affiliation: Cairo University
last name: Aya Omar Hussien, MD
phone: 01002877503
phone ext: 002
email: ayaomar8846@gmail.com
last name: shereen H Ibrahim, A.professor
phone: 01099296591
phone ext: 002
email: shereen.hafez@dentistry.cu.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Aya Omar Tawfik Hussien
investigator title: Assistant lecturer in conservative department of faculty of dentistry