<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/NCT03791099</url>
  </required_header>
  <id_info>
    <org_study_id>KB 98/2016</org_study_id>
    <nct_id>NCT03791099</nct_id>
  </id_info>
  <brief_title>Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.</brief_title>
  <official_title>Preparation and Analysis of Material, Biological and Clinical Parameters of Metronidazole-loaded Porous Matrices for Local Periodontitis Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wroclaw Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wroclaw Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study is the efficiency assessment of porous Metronidazole loaded matrix based on&#xD;
      gelatin/hydroxyethylcellulose blend in treatment of deep periodontal pockets resulting from&#xD;
      severe chronic periodontitis. The matrix was invented and produced in Department of Drug Form&#xD;
      Technology, Wroclaw Medical University.&#xD;
&#xD;
      The porous metronidazole (MTZ) loaded matrix was fabricated by the freeze-drying technique.&#xD;
      The morphology, mechanical properties, in vitro degradation, MTZ release from dried sponge&#xD;
      were evaluated and also the clinical trials were performed.&#xD;
&#xD;
      Patients suffering from chronic periodontitis are examined. To evaluate oral hygiene API&#xD;
      (Approximal Plaque Index) and the gum inflammation BOP (Bleeding on Probing) and PBI (Papilla&#xD;
      Bleeding Index) indices are used. The clinical examination is performed 3 times. On the first&#xD;
      visit the output indicators are defined. The subgingival scaling is performed and&#xD;
      Metronidazol on porous matrix is applied to the selected periodontal pockets. 2 control tests&#xD;
      of periodontal indices are carried out after one week and one month from the application.&#xD;
&#xD;
      In the control group after scaling/root planing procedure, there is no application of&#xD;
      metronidazole.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 23, 2018</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PD</measure>
    <time_frame>4 weeks after the first visit</time_frame>
    <description>Periodontal pocket depth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>API</measure>
    <time_frame>4 weeks after the first visit</time_frame>
    <description>Approximal Plaque Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BoP</measure>
    <time_frame>4 weeks after the first visit</time_frame>
    <description>Bleeding of probing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PBI</measure>
    <time_frame>4 weeks after the first visit</time_frame>
    <description>Papilla bleeding index</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Metronidazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>19,8 mg of metronidazole in one polymer matrix</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only SRP</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard non-surgical treatment- scaling/root planing</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole</intervention_name>
    <description>After subgingival ultrasonic scaling is performed, metronidazole in polymer matrix is applied to the selected periodontal pockets.</description>
    <arm_group_label>Metronidazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-smokers&#xD;
&#xD;
          -  suffering from chronic periodontitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any antibiotics taken systematically or locally in the preceding six months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marek Ziętek, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Periodontology, Wroclaw Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wroclaw Medical University</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-425</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Pandit N, Dahiya R, Gupta R, Bali D, Kathuria A. Comparative evaluation of locally delivered minocycline and metronidazole in the treatment of periodontitis. Contemp Clin Dent. 2013 Jan;4(1):48-53. doi: 10.4103/0976-237X.111615.</citation>
    <PMID>23853452</PMID>
  </reference>
  <reference>
    <citation>Da Rocha HA, Silva CF, Santiago FL, Martins LG, Dias PC, De Magalhaes D. Local Drug Delivery Systems in the Treatment of Periodontitis: A Literature Review. J Int Acad Periodontol. 2015 Jul;17(3):82-90.</citation>
    <PMID>26373225</PMID>
  </reference>
  <reference>
    <citation>Ahmed EM. Hydrogel: Preparation, characterization, and applications: A review. J Adv Res. 2015 Mar;6(2):105-21. doi: 10.1016/j.jare.2013.07.006. Epub 2013 Jul 18.</citation>
    <PMID>25750745</PMID>
  </reference>
  <reference>
    <citation>Gautam S, Dinda AK, Mishra NC. Fabrication and characterization of PCL/gelatin composite nanofibrous scaffold for tissue engineering applications by electrospinning method. Mater Sci Eng C Mater Biol Appl. 2013 Apr 1;33(3):1228-35. doi: 10.1016/j.msec.2012.12.015. Epub 2012 Dec 8.</citation>
    <PMID>23827565</PMID>
  </reference>
  <reference>
    <citation>Pachuau L. Recent developments in novel drug delivery systems for wound healing. Expert Opin Drug Deliv. 2015;12(12):1895-909. doi: 10.1517/17425247.2015.1070143. Epub 2015 Aug 4.</citation>
    <PMID>26289672</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wroclaw Medical University</investigator_affiliation>
    <investigator_full_name>Malgorzata Szulc</investigator_full_name>
    <investigator_title>Assistant Professor in Periodontology Department</investigator_title>
  </responsible_party>
  <keyword>Periodontitis treatment</keyword>
  <keyword>Periodonal pockets</keyword>
  <keyword>local delivery drugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03791099
org study id: KB 98/2016
nct id: NCT03791099
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim of the study is the efficiency assessment of porous Metronidazole loaded matrix based on
      gelatin/hydroxyethylcellulose blend in treatment of deep periodontal pockets resulting from
      severe chronic periodontitis. The matrix was invented and produced in Department of Drug Form
      Technology, Wroclaw Medical University.

      The porous metronidazole (MTZ) loaded matrix was fabricated by the freeze-drying technique.
      The morphology, mechanical properties, in vitro degradation, MTZ release from dried sponge
      were evaluated and also the clinical trials were performed.

      Patients suffering from chronic periodontitis are examined. To evaluate oral hygiene API
      (Approximal Plaque Index) and the gum inflammation BOP (Bleeding on Probing) and PBI (Papilla
      Bleeding Index) indices are used. The clinical examination is performed 3 times. On the first
      visit the output indicators are defined. The subgingival scaling is performed and
      Metronidazol on porous matrix is applied to the selected periodontal pockets. 2 control tests
      of periodontal indices are carried out after one week and one month from the application.

      In the control group after scaling/root planing procedure, there is no application of
      metronidazole.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PD
time frame: 4 weeks after the first visit
description: Periodontal pocket depth
measure: API
time frame: 4 weeks after the first visit
description: Approximal Plaque Index
measure: BoP
time frame: 4 weeks after the first visit
description: Bleeding of probing
measure: PBI
time frame: 4 weeks after the first visit
description: Papilla bleeding index
arm group label: Metronidazole
arm group type: Experimental
description: 19,8 mg of metronidazole in one polymer matrix
arm group label: Only SRP
arm group type: No Intervention
description: standard non-surgical treatment- scaling/root planing
intervention type: Drug
intervention name: Metronidazole
description: After subgingival ultrasonic scaling is performed, metronidazole in polymer matrix is applied to the selected periodontal pockets.
arm group label: Metronidazole
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marek Ziętek, Prof
role: Study Chair
affiliation: Department of Periodontology, Wroclaw Medical University
facility: 
country: Poland
citation: Pandit N, Dahiya R, Gupta R, Bali D, Kathuria A. Comparative evaluation of locally delivered minocycline and metronidazole in the treatment of periodontitis. Contemp Clin Dent. 2013 Jan;4(1):48-53. doi: 10.4103/0976-237X.111615.
PMID: 23853452
citation: Da Rocha HA, Silva CF, Santiago FL, Martins LG, Dias PC, De Magalhaes D. Local Drug Delivery Systems in the Treatment of Periodontitis: A Literature Review. J Int Acad Periodontol. 2015 Jul;17(3):82-90.
PMID: 26373225
citation: Ahmed EM. Hydrogel: Preparation, characterization, and applications: A review. J Adv Res. 2015 Mar;6(2):105-21. doi: 10.1016/j.jare.2013.07.006. Epub 2013 Jul 18.
PMID: 25750745
citation: Gautam S, Dinda AK, Mishra NC. Fabrication and characterization of PCL/gelatin composite nanofibrous scaffold for tissue engineering applications by electrospinning method. Mater Sci Eng C Mater Biol Appl. 2013 Apr 1;33(3):1228-35. doi: 10.1016/j.msec.2012.12.015. Epub 2012 Dec 8.
PMID: 23827565
citation: Pachuau L. Recent developments in novel drug delivery systems for wound healing. Expert Opin Drug Deliv. 2015;12(12):1895-909. doi: 10.1517/17425247.2015.1070143. Epub 2015 Aug 4.
PMID: 26289672
responsible party type: Principal Investigator
investigator affiliation: Wroclaw Medical University
investigator full name: Malgorzata Szulc
investigator title: Assistant Professor in Periodontology Department
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Metronidazole
sharing ipd: Undecided