<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/NCT02227719</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00077102</org_study_id>
    <nct_id>NCT02227719</nct_id>
  </id_info>
  <brief_title>Customized Titanium Membrane for Growing Jaw Bone Horizontally</brief_title>
  <official_title>The Use of Customized Titanium Membrane for Horizontal Ridge Augmentation With Simultaneous Implant Placement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single center, randomized, controlled, parallel-arm study is planned to investigate&#xD;
      clinical outcomes of horizontal ridge augmentation with simultaneous single implant&#xD;
      placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the&#xD;
      inclusion criteria will be enrolled. They will be randomly placed into one of two treatment&#xD;
      groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a&#xD;
      control. The decision of which material to use will be made after an implant is placed.&#xD;
      Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after&#xD;
      which the implants will be surgically uncovered and restored. Outcome analyses will be&#xD;
      performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from&#xD;
      the implant surgery. Clinical and radiographic parameters will be compared between the two&#xD;
      experimental groups. The primary outcome is linear increase of horizontal ridge width from&#xD;
      direct measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding&#xD;
  </why_stopped>
  <start_date>September 2015</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>linear bone gain</measure>
    <time_frame>4 months after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>implant marginal bone level</measure>
    <time_frame>18 months after baseline surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Bone Gain</condition>
  <arm_group>
    <arm_group_label>Test: CTI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CTI is titanium mesh</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: Collagen membrane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Collagen membrane is used for ridge augmentation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CTI</intervention_name>
    <description>CTI is the titanium mesh</description>
    <arm_group_label>Test: CTI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Collagen membrane</intervention_name>
    <arm_group_label>Control: Collagen membrane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age &gt;18&#xD;
&#xD;
          -  Overall good, stable health&#xD;
&#xD;
          -  A single missing mandibular 1st molar for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical conditions that may contradict implant and bone surgery or influence the&#xD;
             outcome (detailed criteria in case report form)&#xD;
&#xD;
          -  Pregnancy or lactating mothers&#xD;
&#xD;
          -  Current heavy smokers (&gt;10 cigarettes/day) or previous heavy smokers who have quit&#xD;
             less than one year&#xD;
&#xD;
          -  Unstable or unsuitable oral conditions for implant and bone surgery (detailed criteria&#xD;
             in case report form)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Michigan School of Dentistry</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>January 22, 2016</last_update_submitted>
  <last_update_submitted_qc>January 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Hsun-Liang Chan</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>after augmentation</keyword>
  <keyword>procedure</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/NCT02227719
org study id: HUM00077102
nct id: NCT02227719
lead sponsor: 
has dmc: No
A single center, randomized, controlled, parallel-arm study is planned to investigate
      clinical outcomes of horizontal ridge augmentation with simultaneous single implant
      placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the
      inclusion criteria will be enrolled. They will be randomly placed into one of two treatment
      groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a
      control. The decision of which material to use will be made after an implant is placed.
      Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after
      which the implants will be surgically uncovered and restored. Outcome analyses will be
      performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from
      the implant surgery. Clinical and radiographic parameters will be compared between the two
      experimental groups. The primary outcome is linear increase of horizontal ridge width from
      direct measurements.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: linear bone gain
time frame: 4 months after surgery
measure: implant marginal bone level
time frame: 18 months after baseline surgery
arm group label: Test: CTI
arm group type: Experimental
description: CTI is titanium mesh
arm group label: Control: Collagen membrane
arm group type: Active Comparator
description: Collagen membrane is used for ridge augmentation
intervention type: Device
intervention name: CTI
description: CTI is the titanium mesh
arm group label: Test: CTI
intervention type: Device
intervention name: Collagen membrane
arm group label: Control: Collagen membrane
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Hsun-Liang Chan
investigator title: Clinical Assistant Professor