<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/NCT03795727</url>
  </required_header>
  <id_info>
    <org_study_id>circumferential vs sectional</org_study_id>
    <nct_id>NCT03795727</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact</brief_title>
  <official_title>Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact by Undergraduate Students and Postgraduate Dentists: Randomized Controlled 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>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 study is to evaluate the effects of different matricing techniques either&#xD;
      sectional matrix or circumferential matrix on reproduction of optimum proximal contacts and&#xD;
      contours during restoration of class II cavities with resin composite by undergraduate&#xD;
      students or postgraduate dentists.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2020</start_date>
  <completion_date type="Actual">March 12, 2020</completion_date>
  <primary_completion_date type="Actual">February 12, 2020</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>Proximal contact</measure>
    <time_frame>Up to 3 hours from randomization till contact is restored</time_frame>
    <description>Reproduction of proximal contact either optimum, tight or loose (Categorical)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Proximal Contact</condition>
  <arm_group>
    <arm_group_label>Sectional matrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>precontoured sectional matrix band</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Circumferential matrix</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Circumferential matrix band applied by tofflemire retainer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MD ring and precontoured sectional matrix by TOR VM</intervention_name>
    <description>MD ring (separation ring) and precontoured sectional matrix (thickness 0.035mm hard) and a wedge was used to secure matrix in place</description>
    <arm_group_label>Sectional matrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Circumferential matrix and tofflemire retainer by Kerr</intervention_name>
    <description>Circumferential matrix (thickness 0.038mm) applied by tofflemire retainer and secured in place with wedge</description>
    <arm_group_label>Circumferential matrix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Compound class II cavities&#xD;
&#xD;
          -  Good oral hygiene&#xD;
&#xD;
          -  No spacing or crowding&#xD;
&#xD;
          -  Healthy peridontium&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complex class II cavities&#xD;
&#xD;
          -  Poor oral hygiene&#xD;
&#xD;
          -  Spacing or crowding&#xD;
&#xD;
          -  Evidence of peridontal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Dentistry, Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>El Manial</state>
        <zip>11553</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>April 17, 2020</last_update_submitted>
  <last_update_submitted_qc>April 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Omar Osama Shaalan</investigator_full_name>
    <investigator_title>Lecturer of conservative dentistry, Faculty of Dentistry</investigator_title>
  </responsible_party>
  <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/NCT03795727
org study id: circumferential vs sectional
nct id: NCT03795727
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the effects of different matricing techniques either
      sectional matrix or circumferential matrix on reproduction of optimum proximal contacts and
      contours during restoration of class II cavities with resin composite by undergraduate
      students or postgraduate dentists.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Proximal contact
time frame: Up to 3 hours from randomization till contact is restored
description: Reproduction of proximal contact either optimum, tight or loose (Categorical)
arm group label: Sectional matrix
arm group type: Experimental
description: precontoured sectional matrix band
arm group label: Circumferential matrix
arm group type: Active Comparator
description: Circumferential matrix band applied by tofflemire retainer
intervention type: Device
intervention name: MD ring and precontoured sectional matrix by TOR VM
description: MD ring (separation ring) and precontoured sectional matrix (thickness 0.035mm hard) and a wedge was used to secure matrix in place
arm group label: Sectional matrix
intervention type: Device
intervention name: Circumferential matrix and tofflemire retainer by Kerr
description: Circumferential matrix (thickness 0.038mm) applied by tofflemire retainer and secured in place with wedge
arm group label: Circumferential matrix
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Omar Osama Shaalan
investigator title: Lecturer of conservative dentistry, Faculty of Dentistry
sharing ipd: No