<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/NCT01662388</url>
  </required_header>
  <id_info>
    <org_study_id>640-Sur-ERC-06</org_study_id>
    <secondary_id>640-Sur/ERC-06</secondary_id>
    <nct_id>NCT01662388</nct_id>
  </id_info>
  <brief_title>A Clinical Trial of Proximal Composite Restorations</brief_title>
  <acronym>Automatrix</acronym>
  <official_title>A Clinical Trial of Proximal Composite Restorations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several techniques have been advocated to get good contacts in dental composite restorations&#xD;
      including interdental separation ring. The investigators study focuses on using separation&#xD;
      ring with circumferential matrix band instead of a sectional band. Moreover, the&#xD;
      investigators have attempted to study proximal tightness and proximal contours of composite&#xD;
      restoration as separate variables&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 188 premolar teeth with proximal cavity to be assigned on alternate basis in two&#xD;
      groups. Intervention group teeth received Automatrix band after cavity preparation followed&#xD;
      by the separation ring using clamp while the control group received Automatrix band alone.&#xD;
&#xD;
      All teeth to be restored with P-60 composite restorative material(3M-ESPE Dental, USA).&#xD;
      Outcome (proximal tightness) is determined by a blinded assessor just after the restoration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proximal tightness</measure>
    <time_frame>1 day (just after dental restoration)</time_frame>
    <description>The tightness of the proximal contact area resulting from either of the two matrix band system. It was measured using a nine inch long nylon dental floss (Johnson and Johnson, USA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>proximal contours</measure>
    <time_frame>1 day (just after restoration placement)</time_frame>
    <description>To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overhang of the restoration</measure>
    <time_frame>1 day (just after the restoration placement)</time_frame>
    <description>To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">188</enrollment>
  <condition>Class II Caries in Premolars</condition>
  <arm_group>
    <arm_group_label>automatrix band, Separation ring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The prepared teeth received Automatrix band (similar to the control group, product code# 62422513). The Automatrix was burnished against the adjacent tooth gently. Anatomical wedges were applied in the proximal area and then the separation ring (BiTine® round ring by Palodent systems, Dentsply International, DE, USA product # 659040) placed with the help of retainer forceps.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>automatrix band</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Teeth received Automatrix band alone (Wide-Regular type, dimensions 7.9 mm height and 0.05mm thickness, product code # 62422513). It was secured on the prepared tooth and burnished against the adjacent tooth gently. Anatomical wedges were placed in the inter-proximal area gingival to the cavity preparation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Separation ring</intervention_name>
    <description>Separation ring placed along with automatrix band</description>
    <arm_group_label>automatrix band, Separation ring</arm_group_label>
    <other_name>BiTine® Separation ring by Palodent, product # 659040)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>automatrix band</intervention_name>
    <description>band placed with a tightening device</description>
    <arm_group_label>automatrix band</arm_group_label>
    <arm_group_label>automatrix band, Separation ring</arm_group_label>
    <other_name>circumferential automatrix band by Dentsply</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who had supra gingival Class II cavities in permanent premolars. Teeth with&#xD;
             cavity isthmus less than one-third of intercuspal distance were inducted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Partially erupted teeth, teeth with non-carious tooth surface wear or with orthodontic&#xD;
             bands or brackets or whose adjacent tooth continuous with the cavity side is missing&#xD;
             were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farhan R Khan, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>AKU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dental Clinics, Aga Khan University Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>April 19, 2017</last_update_submitted>
  <last_update_submitted_qc>April 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Farhan Raza Khan</investigator_full_name>
    <investigator_title>Assistant Professor, Dentistry</investigator_title>
  </responsible_party>
  <keyword>proximal caries, composite restoration, proximal contact</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/NCT01662388
org study id: 640-Sur-ERC-06
secondary id: 640-Sur/ERC-06
nct id: NCT01662388
lead sponsor: 
has dmc: Yes
Several techniques have been advocated to get good contacts in dental composite restorations
      including interdental separation ring. The investigators study focuses on using separation
      ring with circumferential matrix band instead of a sectional band. Moreover, the
      investigators have attempted to study proximal tightness and proximal contours of composite
      restoration as separate variables
A total of 188 premolar teeth with proximal cavity to be assigned on alternate basis in two
      groups. Intervention group teeth received Automatrix band after cavity preparation followed
      by the separation ring using clamp while the control group received Automatrix band alone.

      All teeth to be restored with P-60 composite restorative material(3M-ESPE Dental, USA).
      Outcome (proximal tightness) is determined by a blinded assessor just after the restoration.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: proximal tightness
time frame: 1 day (just after dental restoration)
description: The tightness of the proximal contact area resulting from either of the two matrix band system. It was measured using a nine inch long nylon dental floss (Johnson and Johnson, USA).
measure: proximal contours
time frame: 1 day (just after restoration placement)
description: To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator.
measure: Overhang of the restoration
time frame: 1 day (just after the restoration placement)
description: To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator.
arm group label: automatrix band, Separation ring
arm group type: Experimental
description: The prepared teeth received Automatrix band (similar to the control group, product code# 62422513). The Automatrix was burnished against the adjacent tooth gently. Anatomical wedges were applied in the proximal area and then the separation ring (BiTine® round ring by Palodent systems, Dentsply International, DE, USA product # 659040) placed with the help of retainer forceps.
arm group label: automatrix band
arm group type: Active Comparator
description: Teeth received Automatrix band alone (Wide-Regular type, dimensions 7.9 mm height and 0.05mm thickness, product code # 62422513). It was secured on the prepared tooth and burnished against the adjacent tooth gently. Anatomical wedges were placed in the inter-proximal area gingival to the cavity preparation.
intervention type: Device
intervention name: Separation ring
description: Separation ring placed along with automatrix band
arm group label: automatrix band, Separation ring
other name: BiTine® Separation ring by Palodent, product # 659040)
intervention type: Device
intervention name: automatrix band
description: band placed with a tightening device
arm group label: automatrix band
arm group label: automatrix band, Separation ring
other name: circumferential automatrix band by Dentsply
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Farhan R Khan, FCPS
role: Principal Investigator
affiliation: AKU
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Farhan Raza Khan
investigator title: Assistant Professor, Dentistry