<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/NCT02972788</url>
  </required_header>
  <id_info>
    <org_study_id>783-16</org_study_id>
    <nct_id>NCT02972788</nct_id>
  </id_info>
  <brief_title>Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients</brief_title>
  <official_title>Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the effect of enamel matrix protein derivative on an&#xD;
      inflamed, periodontal-involved tooth. The hypothesis to be studied is that enamel matrix&#xD;
      derivative protein with increase the clinical attachment level is localized sites of advanced&#xD;
      periodontal disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine if local application of a commercially-available,&#xD;
      FDA-approved preparation of enamel-matrix protein derivatives is effective in increasing&#xD;
      clinical attachment levels (primary outcome), as well as alveolar bone (secondary outcome)&#xD;
      compared to standard mechanical therapy in patients on periodontal maintenance therapy (PMT).&#xD;
      Subjects will be divided into two groups for additional therapy in a 6-9 mm interproximal&#xD;
      periodontal pocket at baseline: 1) local anesthesia and mini-flap reflection with subgingival&#xD;
      mechanical debridement plus application of the enamel matrix protein derivate or 2) local&#xD;
      anesthesia and mini-flap reflection with subgingival mechanical debridement plus application&#xD;
      of saline. Samples/measurements will be obtained at the designated experimental site at&#xD;
      baseline, 2 weeks, 6 and 12 months during PMT: 1) digital radiograph (baseline and 12 months&#xD;
      only; bone height measurements), 2) presence of explorer-detectable supragingival plaque, 3)&#xD;
      30-second gingival crevicular fluid (GCF) sample (markers of inflammation, bone turnover), 4)&#xD;
      recession from the cemento-enamel junction, 5) probing pocket depth and bleeding on probing&#xD;
      (BOP). Following the 12-month visit, the research-specific interventions and measurements in&#xD;
      the experimental quadrant will be removed from routine PMT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">September 20, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Enamel Matrix Proteins on Clinical Attachment Level</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Periodontal Bone Loss</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group will receive enamel matrix protein derivative treatment along with scaling and root planing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Group will receive placebo (saline) treatment along with scaling and root planing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enamel Matrix Proteins Derivative</intervention_name>
    <description>Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy.</description>
    <arm_group_label>Experimental Group</arm_group_label>
    <other_name>Emdogain</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of chronic advanced adult periodontitis&#xD;
&#xD;
          -  one quadrant with at least one 6-9 mm interproximal pocket&#xD;
&#xD;
          -  overall good systemic health&#xD;
&#xD;
          -  willingness to sign consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases which significantly impact periodontal inflammation and bone&#xD;
             turnover (e.g. rheumatoid arthritis)&#xD;
&#xD;
          -  taking drugs which significantly impact periodontal inflammation and bone turnover&#xD;
&#xD;
          -  surgical periodontal therapy within the past year&#xD;
&#xD;
          -  pregnant or breast-feeding females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Killeen, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska Medical Center College of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nebraska Medical Center College of Dentistry</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 12, 2018</last_update_submitted>
  <last_update_submitted_qc>November 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>Amy C. Killeen, DDS, MS</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
  </condition_browse>
  <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/NCT02972788
org study id: 783-16
nct id: NCT02972788
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of the study is to determine the effect of enamel matrix protein derivative on an
      inflamed, periodontal-involved tooth. The hypothesis to be studied is that enamel matrix
      derivative protein with increase the clinical attachment level is localized sites of advanced
      periodontal disease.
The purpose of this study is to determine if local application of a commercially-available,
      FDA-approved preparation of enamel-matrix protein derivatives is effective in increasing
      clinical attachment levels (primary outcome), as well as alveolar bone (secondary outcome)
      compared to standard mechanical therapy in patients on periodontal maintenance therapy (PMT).
      Subjects will be divided into two groups for additional therapy in a 6-9 mm interproximal
      periodontal pocket at baseline: 1) local anesthesia and mini-flap reflection with subgingival
      mechanical debridement plus application of the enamel matrix protein derivate or 2) local
      anesthesia and mini-flap reflection with subgingival mechanical debridement plus application
      of saline. Samples/measurements will be obtained at the designated experimental site at
      baseline, 2 weeks, 6 and 12 months during PMT: 1) digital radiograph (baseline and 12 months
      only; bone height measurements), 2) presence of explorer-detectable supragingival plaque, 3)
      30-second gingival crevicular fluid (GCF) sample (markers of inflammation, bone turnover), 4)
      recession from the cemento-enamel junction, 5) probing pocket depth and bleeding on probing
      (BOP). Following the 12-month visit, the research-specific interventions and measurements in
      the experimental quadrant will be removed from routine PMT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Effect of Enamel Matrix Proteins on Clinical Attachment Level
time frame: 12 months
arm group label: Experimental Group
arm group type: Experimental
description: Group will receive enamel matrix protein derivative treatment along with scaling and root planing.
arm group label: Control Group
arm group type: Sham Comparator
description: Group will receive placebo (saline) treatment along with scaling and root planing.
intervention type: Drug
intervention name: Enamel Matrix Proteins Derivative
description: Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
arm group label: Experimental Group
other name: Emdogain
intervention type: Other
intervention name: Saline
description: Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
arm group label: Control Group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Amy Killeen, DDS, MS
role: Principal Investigator
affiliation: University of Nebraska Medical Center College of Dentistry
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: Amy C. Killeen, DDS, MS
investigator title: Associate Professor
mesh term: Alveolar Bone Loss
sharing ipd: No