xml: <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/NCT05971706</url>
    </required_header>
    <id_info>
      <org_study_id>Ozone</org_study_id>
      <nct_id>NCT05971706</nct_id>
    </id_info>
    <brief_title>Ozone Application in Periodontal Treatment</brief_title>
    <official_title>Impact of Ozone Application in Periodontitis Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Biruni University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Biruni 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>
        This clinical trial aims to evaluate the clinical, biochemical and microbiological efficacy&#xD;
        of ozone treatment as an adjunct to nonsurgical periodontal treatment (NSPT) in periodontitis&#xD;
        patients. The main question it aims to answer is:&#xD;
  &#xD;
        • Is the application of gaseous ozone, as an adjunct to NSPT, to periodontal pockets in&#xD;
        patients with periodontitis alters the clinical periodontal parameters, gingival crevicular&#xD;
        fluid levels of inflammatory cytokines, and periodontal pathogens compared to NSPT alone? The&#xD;
        study will be performed according to a split-mouth design, the contralateral quadrants with&#xD;
        similar periodontal status in each patient will be randomly allocated to one of the following&#xD;
        two different treatment modalities.&#xD;
  &#xD;
        Participants will be applied NSPT consisting of supra and subgingival debridement.&#xD;
  &#xD;
          -  NSPT will be applied alone in one quadrant&#xD;
  &#xD;
          -  In addition to NSPT, ozone therapy procedures were performed using a device at&#xD;
             contralateral sites.&#xD;
  &#xD;
        Researchers will compare the sites with and without ozone therapy in addition to NSPT to see&#xD;
        if ozone therapy adjunct to the NSPT affects clinical, biochemical, and microbiological&#xD;
        changes&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 25, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2024</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, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Probing pocket depth</measure>
      <time_frame>Baseline (prior to therapy)</time_frame>
      <description>Probing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Probing pocket depth</measure>
      <time_frame>3rd month after treatment</time_frame>
      <description>robing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plaque index (Silness &amp; Löe, 1964)</measure>
      <time_frame>Baseline (prior to therapy)</time_frame>
      <description>Plaque index (Silness &amp; Löe, 1964):&#xD;
  0: Absence of microbial plaque&#xD;
  Thin plaque layer at the gingival margin, only detectable by scraping with a probe&#xD;
  Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye&#xD;
  Abundant plaque along with the gingival margin; interdental places filled with plaque</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plaque index (Silness &amp; Löe, 1964)</measure>
      <time_frame>3rd month</time_frame>
      <description>Plaque index (Silness &amp; Löe, 1964):&#xD;
  0: Absence of microbial plaque&#xD;
  Thin plaque layer at the gingival margin, only detectable by scraping with a probe&#xD;
  Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye&#xD;
  Abundant plaque along with the gingival margin; interdental places filled with plaque</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gingival Index ( Löe &amp; Silness,1963)</measure>
      <time_frame>Baseline (prior to therapy)</time_frame>
      <description>0 = normal gingiva&#xD;
  = mild inflammation - slight change in color and slight edema but no bleeding on probing&#xD;
  = moderate inflammation - redness, edema and glazing, bleeding on probing&#xD;
  = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gingival Index ( Löe &amp; Silness,1963)</measure>
      <time_frame>3rd month</time_frame>
      <description>0 = normal gingiva&#xD;
  = mild inflammation - slight change in color and slight edema but no bleeding on probing&#xD;
  = moderate inflammation - redness, edema and glazing, bleeding on probing&#xD;
  = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bleeding on probing</measure>
      <time_frame>Baseline (prior to therapy)</time_frame>
      <description>A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth (Ainamo &amp; Bay 1975).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bleeding on probing</measure>
      <time_frame>3rd month</time_frame>
      <description>A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth (Ainamo &amp; Bay 1975).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportions of bacterial species</measure>
      <time_frame>Baseline (prior to therapy)</time_frame>
      <description>Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportions of bacterial species</measure>
      <time_frame>1st month</time_frame>
      <description>Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportions of bacterial species</measure>
      <time_frame>3rd month</time_frame>
      <description>Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inflammatory parameter levels in gingival crevicular fluid</measure>
      <time_frame>Baseline (prior to therapy)</time_frame>
      <description>Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inflammatory parameter levels in gingival crevicular fluid</measure>
      <time_frame>1st month</time_frame>
      <description>Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inflammatory parameter levels in gingival crevicular fluid</measure>
      <time_frame>3rd month</time_frame>
      <description>Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Periodontitis</condition>
    <arm_group>
      <arm_group_label>ozone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Gaseous ozone was applied immediately after non-surgical periodontal treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Only non-surgical periodontal treatment was applied</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway)</intervention_name>
      <description>Ozone therapy procedures will be performed immediately after non-surgical periodontal treatment and three times (every third day) within one week using a device equipped with a periodontal tip according to equipment producer recommendations. The periodontal tip will be halted 1 mm short of the pocket depth. Ozone will be applied only to the pockets; which depth is equal to or greater than 5 mm. Ozone application time to the pockets will be 30 seconds at a fixed concentration of 2,100 ppm (80% oxygen) through a connected handpiece.</description>
      <arm_group_label>ozone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Non-surgical periodontal treatment</intervention_name>
      <description>Non-surgical periodontal treatment consists of oral hygiene instructions, full mouth supragingival scaling using hand instruments, ultrasonic devices, polishing, and subgingival debridement under local anesthesia with sharp Gracey and Universal curettes and ultrasonic instruments in a single appointment.</description>
      <arm_group_label>control</arm_group_label>
      <arm_group_label>ozone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  systemically healthy&#xD;
  &#xD;
            -  no periodontal treatment within 6 months from the enrollment date&#xD;
  &#xD;
            -  no antibiotics or anti-inflammatory medication taken within 6 months from the&#xD;
               enrollment date&#xD;
  &#xD;
            -  no smokers&#xD;
  &#xD;
            -  no pregnancy or lactation at the time of the stud&#xD;
  &#xD;
            -  no contraindication for periodontal treatment and ozone application&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants will be excluded if they had less than 20 teeth, partial dentures, or&#xD;
               fixed prosthodontics.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Burcu Karaduman, Professor</last_name>
      <phone>+905323763366</phone>
      <email>bkaraduman@biruni.edu.tr</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Biruni University</investigator_affiliation>
      <investigator_full_name>Burcu KARADUMAN</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <keyword>periodontitis</keyword>
    <keyword>ozone</keyword>
    <keyword>treatment</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971706
  org study id: Ozone
  nct id: NCT05971706
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial aims to evaluate the clinical, biochemical and microbiological efficacy
        of ozone treatment as an adjunct to nonsurgical periodontal treatment (NSPT) in periodontitis
        patients. The main question it aims to answer is:
  
        • Is the application of gaseous ozone, as an adjunct to NSPT, to periodontal pockets in
        patients with periodontitis alters the clinical periodontal parameters, gingival crevicular
        fluid levels of inflammatory cytokines, and periodontal pathogens compared to NSPT alone? The
        study will be performed according to a split-mouth design, the contralateral quadrants with
        similar periodontal status in each patient will be randomly allocated to one of the following
        two different treatment modalities.
  
        Participants will be applied NSPT consisting of supra and subgingival debridement.
  
          -  NSPT will be applied alone in one quadrant
  
          -  In addition to NSPT, ozone therapy procedures were performed using a device at
             contralateral sites.
  
        Researchers will compare the sites with and without ozone therapy in addition to NSPT to see
        if ozone therapy adjunct to the NSPT affects clinical, biochemical, and microbiological
        changes
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Probing pocket depth
  time frame: Baseline (prior to therapy)
  description: Probing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
  measure: Probing pocket depth
  time frame: 3rd month after treatment
  description: robing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
  measure: Plaque index (Silness & Löe, 1964)
  time frame: Baseline (prior to therapy)
  description: Plaque index (Silness & Löe, 1964):
  0: Absence of microbial plaque
  Thin plaque layer at the gingival margin, only detectable by scraping with a probe
  Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye
  Abundant plaque along with the gingival margin; interdental places filled with plaque
  measure: Plaque index (Silness & Löe, 1964)
  time frame: 3rd month
  description: Plaque index (Silness & Löe, 1964):
  0: Absence of microbial plaque
  Thin plaque layer at the gingival margin, only detectable by scraping with a probe
  Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye
  Abundant plaque along with the gingival margin; interdental places filled with plaque
  measure: Gingival Index ( Löe & Silness,1963)
  time frame: Baseline (prior to therapy)
  description: 0 = normal gingiva
  = mild inflammation - slight change in color and slight edema but no bleeding on probing
  = moderate inflammation - redness, edema and glazing, bleeding on probing
  = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
  measure: Gingival Index ( Löe & Silness,1963)
  time frame: 3rd month
  description: 0 = normal gingiva
  = mild inflammation - slight change in color and slight edema but no bleeding on probing
  = moderate inflammation - redness, edema and glazing, bleeding on probing
  = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
  measure: Bleeding on probing
  time frame: Baseline (prior to therapy)
  description: A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth (Ainamo & Bay 1975).
  measure: Bleeding on probing
  time frame: 3rd month
  description: A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth (Ainamo & Bay 1975).
  measure: Proportions of bacterial species
  time frame: Baseline (prior to therapy)
  description: Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
  measure: Proportions of bacterial species
  time frame: 1st month
  description: Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
  measure: Proportions of bacterial species
  time frame: 3rd month
  description: Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
  measure: Inflammatory parameter levels in gingival crevicular fluid
  time frame: Baseline (prior to therapy)
  description: Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
  measure: Inflammatory parameter levels in gingival crevicular fluid
  time frame: 1st month
  description: Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
  measure: Inflammatory parameter levels in gingival crevicular fluid
  time frame: 3rd month
  description: Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
  arm group label: ozone
  arm group type: Experimental
  description: Gaseous ozone was applied immediately after non-surgical periodontal treatment
  arm group label: control
  arm group type: Active Comparator
  description: Only non-surgical periodontal treatment was applied
  intervention type: Device
  intervention name: Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway)
  description: Ozone therapy procedures will be performed immediately after non-surgical periodontal treatment and three times (every third day) within one week using a device equipped with a periodontal tip according to equipment producer recommendations. The periodontal tip will be halted 1 mm short of the pocket depth. Ozone will be applied only to the pockets; which depth is equal to or greater than 5 mm. Ozone application time to the pockets will be 30 seconds at a fixed concentration of 2,100 ppm (80% oxygen) through a connected handpiece.
  arm group label: ozone
  intervention type: Procedure
  intervention name: Non-surgical periodontal treatment
  description: Non-surgical periodontal treatment consists of oral hygiene instructions, full mouth supragingival scaling using hand instruments, ultrasonic devices, polishing, and subgingival debridement under local anesthesia with sharp Gracey and Universal curettes and ultrasonic instruments in a single appointment.
  arm group label: control
  arm group label: ozone
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Burcu Karaduman, Professor
  phone: +905323763366
  email: bkaraduman@biruni.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: Biruni University
  investigator full name: Burcu KARADUMAN
  investigator title: Principle Investigator
  mesh term: Periodontitis
  sharing ipd: No