<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/NCT04449393</url>
  </required_header>
  <id_info>
    <org_study_id>1248/2020</org_study_id>
    <nct_id>NCT04449393</nct_id>
  </id_info>
  <brief_title>Enamel Matrix Derivative in Non-surgical Periodontal Treatment</brief_title>
  <official_title>Effect of Enamel Matrix Derivative in the Non-surgical Treatment of Periodontal Maintenance Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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 aim of the study is to investigate the effect of enamel matrix derivative in addition to&#xD;
      scaling and root planing in comparison to scaling and root planing only in periodontitis&#xD;
      patients that have already undergone initial periodontal therapy and are in periodontal&#xD;
      maintenance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enamel matrix derivative (EMD) have already been widely applied as a regenerative&#xD;
      bio-modulator in periodontal surgery and have been demonstrated to enhance periodontal&#xD;
      regeneration. Recently, also its flapless, non-surgical application has been shown to have&#xD;
      beneficial effects when applied during initial therapy of periodontitis.&#xD;
&#xD;
      The present study is designed as a single-blinded randomized controlled clinical trial. We&#xD;
      plan to include a total of 50 periodontitis patients that have already undergone initial&#xD;
      periodontal therapy, but still show remaining sites with increased periodontal probing depth&#xD;
      (PPD). Patients will be randomly allocated at a 1:1 ratio to either scaling and root planing&#xD;
      (SRP) in combination with EMD application into the affected pockets (test group, n=25) or to&#xD;
      SRP only (control group, n=25). Before treatment, as well as after 3, 6 and 12 months, we&#xD;
      plan to assess site-specific periodontal parameters as well as whole-mouth oral hygiene&#xD;
      indices. Furthermore, we intend to evaluate gingival crevicular fluid, as well as parameters&#xD;
      representing periodontal disease activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2022</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Periodontal probing depth (PPD)</measure>
    <time_frame>At baseline</time_frame>
    <description>Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal probing depth (PPD)</measure>
    <time_frame>After 3 months</time_frame>
    <description>Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal probing depth (PPD)</measure>
    <time_frame>After 6 months</time_frame>
    <description>Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal probing depth (PPD)</measure>
    <time_frame>After 12 months</time_frame>
    <description>Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CAL (mm)</measure>
    <time_frame>At baseline, after 3, 6 and 12 months</time_frame>
    <description>CAL (Clinical attachment level): the probing depth and the distance from the gingival margin to the CEJ API: Approximal plaque index PBI: Papillary Bleeding Index PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area GCF: Gingival crevicular fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>API, PBI (%)</measure>
    <time_frame>At baseline, after 3, 6 and 12 months</time_frame>
    <description>API: Approximal plaque index PBI: Papillary Bleeding Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PESA, PISA (mm2)</measure>
    <time_frame>At baseline, after 3, 6 and 12 months</time_frame>
    <description>PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GCF markers for periodontal regeneration</measure>
    <time_frame>At baseline, after 3, 6 and 12 months</time_frame>
    <description>GCF: Gingival crevicular fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periodontal bacteria</measure>
    <time_frame>At baseline, after 3, 6 and 12 months</time_frame>
    <description>Microbiologic evaluation of GCF via polymerase chain reaction (PCR) DNA probe test kit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>Emdogain® FL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-surgical periodontal therapy in terms of scaling and root planing will be applied at sites with remaining periodontal pockets at reevaluation. EDTA gel will be applied for 2 minutes in the respective pockets, followed by rinsing with saline, drying and application of Emdogain® FL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Non-surgical periodontal therapy in terms of scaling and root planing will be applied at sites with remaining periodontal pockets at reevaluation, followed by rinsing with saline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Emdogain® FL</intervention_name>
    <description>Emdogain® FL is an enamel matrix derivative intended for subgingival and topical application in conjunction with scaling and root planing procedures to provide regeneration of tooth support lost due to periodontal disease. Emdogain® FL has been shown to be effective in residual pockets with probing depths from 5mm to 9mm with no furcation involvement in patients with adequate plaque control. Emdogain® FL has also been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.</description>
    <arm_group_label>Emdogain® FL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Scaling and root planing</intervention_name>
    <description>Scaling and root planing procedures as part of non-surgical periodontal therapy involves mechanical removal of dental plaque and calculus using curettes and sonic scalers.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Periodontitis stage III&#xD;
&#xD;
          -  Patients that have completed initial periodontal therapy, and have remaining&#xD;
             periodontal pockets of ≥6mm up to 9mm PPD&#xD;
&#xD;
          -  Given written informed consent form for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic antibiotics within the previous 3 months&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Any current or past clinically significant pathology/disease (comorbidity) that, in&#xD;
             the opinion of the periodontists, might confound the results or poses an additional&#xD;
             risk to the subject during participation in the study, such as renal insufficiency,&#xD;
             malignancy, rheumatoid osteoarthritis, human immunodeficiency syndrome.&#xD;
&#xD;
          -  Patients with at least one tooth of mobility grade 0 or 1 and/or furcation involvement&#xD;
             grade 0 or I according to Hamp&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Clinic of Dentistry Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>October 22, 2022</last_update_submitted>
  <last_update_submitted_qc>October 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Christian Wehner, DMD</investigator_full_name>
    <investigator_title>Dr.med.dent.</investigator_title>
  </responsible_party>
  <keyword>Enamel Matrix Derivative</keyword>
  <keyword>Periodontitis</keyword>
  <keyword>Non-surgical periodontal therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</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/NCT04449393
org study id: 1248/2020
nct id: NCT04449393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the study is to investigate the effect of enamel matrix derivative in addition to
      scaling and root planing in comparison to scaling and root planing only in periodontitis
      patients that have already undergone initial periodontal therapy and are in periodontal
      maintenance.
Enamel matrix derivative (EMD) have already been widely applied as a regenerative
      bio-modulator in periodontal surgery and have been demonstrated to enhance periodontal
      regeneration. Recently, also its flapless, non-surgical application has been shown to have
      beneficial effects when applied during initial therapy of periodontitis.

      The present study is designed as a single-blinded randomized controlled clinical trial. We
      plan to include a total of 50 periodontitis patients that have already undergone initial
      periodontal therapy, but still show remaining sites with increased periodontal probing depth
      (PPD). Patients will be randomly allocated at a 1:1 ratio to either scaling and root planing
      (SRP) in combination with EMD application into the affected pockets (test group, n=25) or to
      SRP only (control group, n=25). Before treatment, as well as after 3, 6 and 12 months, we
      plan to assess site-specific periodontal parameters as well as whole-mouth oral hygiene
      indices. Furthermore, we intend to evaluate gingival crevicular fluid, as well as parameters
      representing periodontal disease activity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Periodontal probing depth (PPD)
time frame: At baseline
description: Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
measure: Periodontal probing depth (PPD)
time frame: After 3 months
description: Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
measure: Periodontal probing depth (PPD)
time frame: After 6 months
description: Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
measure: Periodontal probing depth (PPD)
time frame: After 12 months
description: Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
measure: CAL (mm)
time frame: At baseline, after 3, 6 and 12 months
description: CAL (Clinical attachment level): the probing depth and the distance from the gingival margin to the CEJ API: Approximal plaque index PBI: Papillary Bleeding Index PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area GCF: Gingival crevicular fluid
measure: API, PBI (%)
time frame: At baseline, after 3, 6 and 12 months
description: API: Approximal plaque index PBI: Papillary Bleeding Index
measure: PESA, PISA (mm2)
time frame: At baseline, after 3, 6 and 12 months
description: PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area
measure: GCF markers for periodontal regeneration
time frame: At baseline, after 3, 6 and 12 months
description: GCF: Gingival crevicular fluid
measure: Periodontal bacteria
time frame: At baseline, after 3, 6 and 12 months
description: Microbiologic evaluation of GCF via polymerase chain reaction (PCR) DNA probe test kit
arm group label: Emdogain® FL
arm group type: Experimental
description: Non-surgical periodontal therapy in terms of scaling and root planing will be applied at sites with remaining periodontal pockets at reevaluation. EDTA gel will be applied for 2 minutes in the respective pockets, followed by rinsing with saline, drying and application of Emdogain® FL.
arm group label: Control group
arm group type: Placebo Comparator
description: Non-surgical periodontal therapy in terms of scaling and root planing will be applied at sites with remaining periodontal pockets at reevaluation, followed by rinsing with saline.
intervention type: Device
intervention name: Emdogain® FL
description: Emdogain® FL is an enamel matrix derivative intended for subgingival and topical application in conjunction with scaling and root planing procedures to provide regeneration of tooth support lost due to periodontal disease. Emdogain® FL has been shown to be effective in residual pockets with probing depths from 5mm to 9mm with no furcation involvement in patients with adequate plaque control. Emdogain® FL has also been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.
arm group label: Emdogain® FL
intervention type: Other
intervention name: Scaling and root planing
description: Scaling and root planing procedures as part of non-surgical periodontal therapy involves mechanical removal of dental plaque and calculus using curettes and sonic scalers.
arm group label: Control group
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Christian Wehner, DMD
investigator title: Dr.med.dent.
mesh term: Periodontitis