<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/NCT04477395</url>
  </required_header>
  <id_info>
    <org_study_id>RNN/251/17/KE</org_study_id>
    <nct_id>NCT04477395</nct_id>
  </id_info>
  <brief_title>Omega-3 Polyunsaturated Fatty Acids in Non-surgical Treatment of Periodontitis</brief_title>
  <official_title>Omega-3 Polyunsaturated Fatty Acids EPA and DHA as an Adjunct to Non-surgical Treatment of Periodontitis: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lodz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lodz</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>
      Periodontitis is a chronic multifactorial inflammatory disease that lead to the loss of&#xD;
      supportive tissues around the teeth with gradual deterioration of masticatory function and&#xD;
      esthetics, resulting eventually in the decrease of the quality of life. Host immune response&#xD;
      triggered by bacterial biofilm is responsible for the chronic periodontal inflammation and&#xD;
      ongoing tissue loss. Polyunsaturated fatty acids (PUFAs) omega-3 eicosapentaenoic acid (EPA)&#xD;
      and docosahexaenoic acid (DHA) have anti-inflammatory properties, thus may be used for the&#xD;
      treatment of chronic inflammatory diseases. This study is aimed to evaluate the effect of&#xD;
      dietary supplementation with PUFAs omega-3 in the patients with periodontitis stage III and&#xD;
      IV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Periodontitis is highly prevalent oral disease in humans affecting nearly 50% of the&#xD;
      population worldwide. Periodontitis is multifactorial disease individually accelerated or&#xD;
      decelerated by different factors. One of them, a bacterial biofilm, leads to dysbiosis and&#xD;
      raise of Gram-negative bacteria.This results in the activations of immune response and&#xD;
      clinical signs of periodontal tissue inflammation. Host modulation therapy seems to be an&#xD;
      adequate concept for the treatment of periodontal diseases. The main assumption of this&#xD;
      therapy is to reduce by-stander tissue destruction, to ensure rapid resolution of&#xD;
      inflammation or even to promote regeneration of the periodontal tissues by modifying or&#xD;
      down-regulating the destructive aspects of the host response and by up-regulating the&#xD;
      protective or regenerative responses The goal of the present study was to assess the effect&#xD;
      of high-dose omega-3 PUFAs EPA and DHA on the clinical outcome of non-surgical treatment of&#xD;
      the patients with generalized periodontitis stage III and IV. It was presumed that dietary&#xD;
      supplementation with high-dose EPA and DHA would have the potential to induce a measurable&#xD;
      clinical outcome as a result of reduction of inflammation and minimizing tissue damage&#xD;
      mediated by anti-inflammatory effect of omega-3 PUFAs. To address this issue, a randomized&#xD;
      clinical trial was designed in which EPA and DHA were supplemented in adjunction to the&#xD;
      standard periodontal therapy, scaling and root planning (SRP). Clinical outcomes of active&#xD;
      versus control therapies were measured in addition to the quantifications of saliva&#xD;
      cytokines, chemokines, subgingival biofilm composition and serum levels of lipids.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 10, 2021</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the percent of closed pockets</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>The percent of closed pockets (PD ≤ 4 mm and BOP-) at 3 and 6 months in relation to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the probing depth (PD)</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Mean values of probing depth of all sites with initial PD ≥ 4 mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the clinical attachment level (CAL)</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Mean values of clinical attachment level of all sites with initial PD ≥ 4 mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the bleeding on probing (BOP)</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Percent of all sites with bleeding on probing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the number of sites with PD ≥ 4 mm and BOP+</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Mean values of number of sites with PD ≥ 4 mm and BOP+</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Periodontitis</condition>
  <condition>Therapeutics</condition>
  <condition>Fatty Acids, Unsaturated</condition>
  <arm_group>
    <arm_group_label>SRP plus fish oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive scaling and root planing (SRP) supplemented with the dietary fish oil rich in omega-3 PUFAs: 2.6 g of EPA and 1.8 g DHA daily for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRP alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive scaling and root planing (SRP) only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>fish oil</intervention_name>
    <description>SRP will be supplemented with the dietary fish oil rich in omega-3 PUFAs EPA and DHA for 6 months. Fish oil (BioMarine Medical, 200 ml liquid), obtained from Tasmanian deep sea shark and Norwegian cod liver and sardine, anchovy and mackerel muscle, will be administered two times a day at a dose 10 ml. Daily dose of 20 ml provides 2.6 g of EPA and 1.8 g of DHA.</description>
    <arm_group_label>SRP plus fish oil</arm_group_label>
    <other_name>BioMarine Medical</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SRP only</intervention_name>
    <description>Scaling and root planing will be the only method of treatment.</description>
    <arm_group_label>SRP alone</arm_group_label>
    <arm_group_label>SRP plus fish oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 18 scorable teeth (not including third molars),&#xD;
&#xD;
          -  ≥4 teeth with PD ≥6 mm, CAL ≥5 mm,&#xD;
&#xD;
          -  radiographic evidence of bone loss more than one-third of the root length,&#xD;
&#xD;
          -  no periodontal treatment performed within last 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoking,&#xD;
&#xD;
          -  diabetes,&#xD;
&#xD;
          -  any diseases or disorders that compromise wound healing,&#xD;
&#xD;
          -  chronic inflammatory disease, history of radio- or chemotherapy,&#xD;
&#xD;
          -  nonsteroidal anti-inflammatory drug (NSAIDs) intake &gt; 3 days,&#xD;
&#xD;
          -  use of antibiotics or corticosteroids 3 months prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Natalia Lewkowicz, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Lodz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Periodontology and Oral Mucosal Diseases</name>
      <address>
        <city>Lodz</city>
        <zip>92-213</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>October 28, 2022</last_update_submitted>
  <last_update_submitted_qc>October 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>periodontitis</keyword>
  <keyword>non-surgical treatment</keyword>
  <keyword>eicosapentaenoic acid</keyword>
  <keyword>docosahexaenoic acid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
  </condition_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/NCT04477395
org study id: RNN/251/17/KE
nct id: NCT04477395
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Periodontitis is a chronic multifactorial inflammatory disease that lead to the loss of
      supportive tissues around the teeth with gradual deterioration of masticatory function and
      esthetics, resulting eventually in the decrease of the quality of life. Host immune response
      triggered by bacterial biofilm is responsible for the chronic periodontal inflammation and
      ongoing tissue loss. Polyunsaturated fatty acids (PUFAs) omega-3 eicosapentaenoic acid (EPA)
      and docosahexaenoic acid (DHA) have anti-inflammatory properties, thus may be used for the
      treatment of chronic inflammatory diseases. This study is aimed to evaluate the effect of
      dietary supplementation with PUFAs omega-3 in the patients with periodontitis stage III and
      IV.
Periodontitis is highly prevalent oral disease in humans affecting nearly 50% of the
      population worldwide. Periodontitis is multifactorial disease individually accelerated or
      decelerated by different factors. One of them, a bacterial biofilm, leads to dysbiosis and
      raise of Gram-negative bacteria.This results in the activations of immune response and
      clinical signs of periodontal tissue inflammation. Host modulation therapy seems to be an
      adequate concept for the treatment of periodontal diseases. The main assumption of this
      therapy is to reduce by-stander tissue destruction, to ensure rapid resolution of
      inflammation or even to promote regeneration of the periodontal tissues by modifying or
      down-regulating the destructive aspects of the host response and by up-regulating the
      protective or regenerative responses The goal of the present study was to assess the effect
      of high-dose omega-3 PUFAs EPA and DHA on the clinical outcome of non-surgical treatment of
      the patients with generalized periodontitis stage III and IV. It was presumed that dietary
      supplementation with high-dose EPA and DHA would have the potential to induce a measurable
      clinical outcome as a result of reduction of inflammation and minimizing tissue damage
      mediated by anti-inflammatory effect of omega-3 PUFAs. To address this issue, a randomized
      clinical trial was designed in which EPA and DHA were supplemented in adjunction to the
      standard periodontal therapy, scaling and root planning (SRP). Clinical outcomes of active
      versus control therapies were measured in addition to the quantifications of saliva
      cytokines, chemokines, subgingival biofilm composition and serum levels of lipids.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the percent of closed pockets
time frame: 3 and 6 months
description: The percent of closed pockets (PD ≤ 4 mm and BOP-) at 3 and 6 months in relation to baseline
measure: Change in the probing depth (PD)
time frame: 3 and 6 months
description: Mean values of probing depth of all sites with initial PD ≥ 4 mm
measure: Change in the clinical attachment level (CAL)
time frame: 3 and 6 months
description: Mean values of clinical attachment level of all sites with initial PD ≥ 4 mm
measure: Change in the bleeding on probing (BOP)
time frame: 3 and 6 months
description: Percent of all sites with bleeding on probing
measure: Change in the number of sites with PD ≥ 4 mm and BOP+
time frame: 3 and 6 months
description: Mean values of number of sites with PD ≥ 4 mm and BOP+
arm group label: SRP plus fish oil
arm group type: Experimental
description: Patients will receive scaling and root planing (SRP) supplemented with the dietary fish oil rich in omega-3 PUFAs: 2.6 g of EPA and 1.8 g DHA daily for 6 months.
arm group label: SRP alone
arm group type: Active Comparator
description: Patients will receive scaling and root planing (SRP) only.
intervention type: Dietary Supplement
intervention name: fish oil
description: SRP will be supplemented with the dietary fish oil rich in omega-3 PUFAs EPA and DHA for 6 months. Fish oil (BioMarine Medical, 200 ml liquid), obtained from Tasmanian deep sea shark and Norwegian cod liver and sardine, anchovy and mackerel muscle, will be administered two times a day at a dose 10 ml. Daily dose of 20 ml provides 2.6 g of EPA and 1.8 g of DHA.
arm group label: SRP plus fish oil
other name: BioMarine Medical
intervention type: Procedure
intervention name: SRP only
description: Scaling and root planing will be the only method of treatment.
arm group label: SRP alone
arm group label: SRP plus fish oil
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Natalia Lewkowicz, Prof.
role: Principal Investigator
affiliation: Medical University of Lodz
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Periodontitis
sharing ipd: Undecided