<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/NCT03290638</url>
  </required_header>
  <id_info>
    <org_study_id>13-0540-F3R</org_study_id>
    <nct_id>NCT03290638</nct_id>
  </id_info>
  <brief_title>Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration</brief_title>
  <acronym>GBR</acronym>
  <official_title>Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (Socket Augmentation) : A Clinical and Histological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samer Faraj</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</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 objective of this randomized clinical study was to evaluate the use of dehydrated human&#xD;
      amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth&#xD;
      extraction and to determine whether intentional exposure of this membrane to the oral&#xD;
      environment compromises ridge dimensions and bone vitality for implant placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty-three patients requiring extraction of at least one tooth and delayed implant placement&#xD;
      were randomly assigned to either an experimental or a control group. For both groups,&#xD;
      demineralized freeze-dried bone allograft was used to graft the socket. For the control&#xD;
      group, Type I bovine collagen was used as a membrane; for the experimental group, human&#xD;
      amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed,&#xD;
      and no primary closure was achieved. Patients returned for implant placement after a mean&#xD;
      healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was&#xD;
      obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times&#xD;
      of extraction and implant placement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2013</start_date>
  <completion_date type="Actual">October 1, 2016</completion_date>
  <primary_completion_date type="Actual">October 1, 2016</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alveolar Ridge Dimensional Changes</measure>
    <time_frame>Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks</time_frame>
    <description>Clinical ridge height changes were taken with a thermoplastic triad stent, and a University of North Carolina (UNC) 15 periodontal probe. Ridge width changes measurements were taken with a metal bone caliper. Alveolar ridge dimensional changes in height and width were measured at the times of extraction and at the time of implant placement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alveolar Ridge Bone Vitality</measure>
    <time_frame>Mean= 19.5 weeks after tooth extraction and bone grafting</time_frame>
    <description>a core bone biopsy specimen 2 mm in diameter was obtained from the center of the root at the time of implant placement for histomorphometric analyses</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ridge Healing Evaluation</measure>
    <time_frame>Two weeks form the time of the extraction</time_frame>
    <description>Pictures of the healing ridges were taken using clinical macro lens photography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Ridge Deficiency</condition>
  <arm_group>
    <arm_group_label>Dehydrated Human Amnion Chorion Membrane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This membrane was investigated to evaluate its use as an open barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type I Bovine Collagen Membrane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This membrane has been tested as an open barrier for GBR after tooth extraction. The intentional use of this membrane to the oral environment did not compromise ridge dimensions and bone vitality for implant placement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Guided Bone Regeneration (GBR)</intervention_name>
    <description>Teeth Extraction With Bone Grafting and Membrane</description>
    <arm_group_label>Dehydrated Human Amnion Chorion Membrane</arm_group_label>
    <arm_group_label>Type I Bovine Collagen Membrane</arm_group_label>
    <other_name>Ridge Preservation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: .&#xD;
&#xD;
        Patients included in the study were required:&#xD;
&#xD;
          -  Not to be completely edentulous.&#xD;
&#xD;
          -  To have at least 1 tooth that could not be saved and for which extraction and delayed&#xD;
             implant placement were planned&#xD;
&#xD;
        Exclusion Criteria: Patients were excluded if they :&#xD;
&#xD;
          -  Had received radiation therapy&#xD;
&#xD;
          -  Were taking antiresorptive medication (i.e., bisphosphonate or denosumab)&#xD;
&#xD;
          -  Had uncontrolled systemic disorders (such as uncontrolled diabetes, congestive heart&#xD;
             failure, or acute odontogenic infections)&#xD;
&#xD;
          -  Were smokers (more than 10 cigarettes per day)&#xD;
&#xD;
          -  Were pregnant or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 17, 2017</last_update_submitted>
  <last_update_submitted_qc>September 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Samer Faraj</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Guided Bone Regeneration</keyword>
  <keyword>Dehydrated Human Amnion Chorion Membrane</keyword>
  <keyword>Type I Bovine Collagen Membrane</keyword>
  <keyword>Ridge Preservation</keyword>
  <keyword>Ridge Healing</keyword>
  <keyword>Teeth Extraction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dehydration</mesh_term>
  </condition_browse>
  <!-- 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/NCT03290638
org study id: 13-0540-F3R
nct id: NCT03290638
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this randomized clinical study was to evaluate the use of dehydrated human
      amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth
      extraction and to determine whether intentional exposure of this membrane to the oral
      environment compromises ridge dimensions and bone vitality for implant placement.
Forty-three patients requiring extraction of at least one tooth and delayed implant placement
      were randomly assigned to either an experimental or a control group. For both groups,
      demineralized freeze-dried bone allograft was used to graft the socket. For the control
      group, Type I bovine collagen was used as a membrane; for the experimental group, human
      amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed,
      and no primary closure was achieved. Patients returned for implant placement after a mean
      healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was
      obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times
      of extraction and implant placement.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Alveolar Ridge Dimensional Changes
time frame: Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks
description: Clinical ridge height changes were taken with a thermoplastic triad stent, and a University of North Carolina (UNC) 15 periodontal probe. Ridge width changes measurements were taken with a metal bone caliper. Alveolar ridge dimensional changes in height and width were measured at the times of extraction and at the time of implant placement.
measure: Alveolar Ridge Bone Vitality
time frame: Mean= 19.5 weeks after tooth extraction and bone grafting
description: a core bone biopsy specimen 2 mm in diameter was obtained from the center of the root at the time of implant placement for histomorphometric analyses
measure: Ridge Healing Evaluation
time frame: Two weeks form the time of the extraction
description: Pictures of the healing ridges were taken using clinical macro lens photography
arm group label: Dehydrated Human Amnion Chorion Membrane
arm group type: Experimental
description: This membrane was investigated to evaluate its use as an open barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.
arm group label: Type I Bovine Collagen Membrane
arm group type: Active Comparator
description: This membrane has been tested as an open barrier for GBR after tooth extraction. The intentional use of this membrane to the oral environment did not compromise ridge dimensions and bone vitality for implant placement.
intervention type: Procedure
intervention name: Guided Bone Regeneration (GBR)
description: Teeth Extraction With Bone Grafting and Membrane
arm group label: Dehydrated Human Amnion Chorion Membrane
arm group label: Type I Bovine Collagen Membrane
other name: Ridge Preservation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 78 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Samer Faraj
investigator title: Principal Investigator
mesh term: Dehydration