<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/NCT03268473</url>
  </required_header>
  <id_info>
    <org_study_id>boz001</org_study_id>
    <nct_id>NCT03268473</nct_id>
  </id_info>
  <brief_title>Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in OSAS</brief_title>
  <acronym>OSAS</acronym>
  <official_title>Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in Obstructive Sleep Apnea Syndrome (OSAS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif 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>
      The main objective of this study is to investigate whether the non-surgical periodontal&#xD;
      treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects&#xD;
      the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is evidence supporting that OSAS is an independent risk factor for cardiovascular and&#xD;
      cerebrovascular diseases such as hypertension, congestive heart failure, myocardial&#xD;
      infarction, cardiac-arrhythmia, and stroke.Gender, age, smoking, obesity and diabetes, which&#xD;
      are risk factors for periodontitis,It is also common in OSAS at the same time.In addition to&#xD;
      common risk factors, both OSAS and periodontitis have been shown to be associated with&#xD;
      increased cystic inflammation.It has been reported that elevated inflammatory markers in OSAS&#xD;
      patients may be associated with periodontal inflammation, although the mechanism of OSAS to&#xD;
      systemic inflammation has not yet been clarified.&#xD;
&#xD;
      The investigators aimed to investigate whether the non-surgical periodontal treatment of&#xD;
      patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the course of&#xD;
      OSAS positively with polysomnographic, serum and saliva parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</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>
    <intervention_model_description>It's an assessor blinded, parallel group, randomized controlled trial aimed at investigate whether the non-surgical periodontal treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL))</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in inflammatory parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL))</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in inflammatory parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL))</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in inflammatory parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum C reactive protein (CRP) (nanogram per milliliter (ng/mL))</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in inflammatory parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL))</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in inflammatory parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva C reactive protein (CRP) (nanogram per milliliter (ng/mL))</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in inflammatory parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL))</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in inflammatory parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL))</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in inflammatory parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL))</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in inflammatory parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL))</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in inflammatory parameters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plaque Index (PI)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in clinical measures of chronic periodontitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Index (GI)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in clinical measures of chronic periodontitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing (BOP)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in clinical measures of chronic periodontitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment loss(CAL)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in clinical measures of chronic periodontitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing pocket depth (PD)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in clinical measures of chronic periodontitis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Periodontitis</condition>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>OSAS</condition>
  <arm_group>
    <arm_group_label>Experimental: Non-surgical periodontal therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-surgical periodontal therapy consisted of scaling and root planing and supportive periodontal therapy during 3 months&#xD;
Intervention: Procedure: Non-surgical periodontal therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed non-surgical periodontal therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No periodontal treatment for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-surgical periodontal therapy</intervention_name>
    <description>Experimental: Non-surgical periodontal therapy (scaling and root planing) and supportive periodontal therapy</description>
    <arm_group_label>Experimental: Non-surgical periodontal therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Delayed non-surgical periodontal therapy</intervention_name>
    <description>Delayed non-surgical periodontal therapy (scaling and root planing) after the 3 month visit</description>
    <arm_group_label>Delayed non-surgical periodontal therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged ≥18 years old&#xD;
&#xD;
          -  having more than 16 teeth&#xD;
&#xD;
          -  BMI&gt;25 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with a history of diabetes mellitus or respiratory diseases&#xD;
&#xD;
          -  patients who were under any medication that was known to influence periodontal tissues&#xD;
&#xD;
          -  patients with a history of any periodontal treatment in the past 6 months&#xD;
&#xD;
          -  patients with hormonal changes such as pregnancy or lactation; and 5) patients having&#xD;
             fixed dentures or removable prothesis&#xD;
&#xD;
          -  OSAS treatment started (using OSAS therapy device or undergoing surgical operation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zeliha Betul Özsağır</last_name>
    <role>Study Chair</role>
    <affiliation>Bezmialem VU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bezmialem Vakıf University, Faculty of Dentistry, Deparment of Periodontology,</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Loke W, Girvan T, Ingmundson P, Verrett R, Schoolfield J, Mealey BL. Investigating the association between obstructive sleep apnea and periodontitis. J Periodontol. 2015 Feb;86(2):232-43. doi: 10.1902/jop.2014.140229. Epub 2014 Oct 9.</citation>
    <PMID>25299385</PMID>
  </reference>
  <results_reference>
    <citation>Gamsiz-Isik H, Kiyan E, Bingol Z, Baser U, Ademoglu E, Yalcin F. Does Obstructive Sleep Apnea Increase the Risk for Periodontal Disease? A Case-Control Study. J Periodontol. 2017 May;88(5):443-449. doi: 10.1902/jop.2016.160365. Epub 2016 Nov 18.</citation>
    <PMID>27858556</PMID>
  </results_reference>
  <results_reference>
    <citation>DPTT study group; Engebretson S, Gelato M, Hyman L, Michalowicz BS, Schoenfeld E. Design features of the Diabetes and Periodontal Therapy Trial (DPTT): a multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes and chronic periodontitis. Contemp Clin Trials. 2013 Nov;36(2):515-26. doi: 10.1016/j.cct.2013.09.010. Epub 2013 Sep 27.</citation>
    <PMID>24080100</PMID>
  </results_reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>November 8, 2021</last_update_submitted>
  <last_update_submitted_qc>November 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OSAS</keyword>
  <keyword>Obstructive Sleep Apnea</keyword>
  <keyword>Periodontitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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/NCT03268473
org study id: boz001
nct id: NCT03268473
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to investigate whether the non-surgical periodontal
      treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects
      the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.
There is evidence supporting that OSAS is an independent risk factor for cardiovascular and
      cerebrovascular diseases such as hypertension, congestive heart failure, myocardial
      infarction, cardiac-arrhythmia, and stroke.Gender, age, smoking, obesity and diabetes, which
      are risk factors for periodontitis,It is also common in OSAS at the same time.In addition to
      common risk factors, both OSAS and periodontitis have been shown to be associated with
      increased cystic inflammation.It has been reported that elevated inflammatory markers in OSAS
      patients may be associated with periodontal inflammation, although the mechanism of OSAS to
      systemic inflammation has not yet been clarified.

      The investigators aimed to investigate whether the non-surgical periodontal treatment of
      patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the course of
      OSAS positively with polysomnographic, serum and saliva parameters.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: It's an assessor blinded, parallel group, randomized controlled trial aimed at investigate whether the non-surgical periodontal treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Serum Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL))
time frame: 3 months
description: Changes in inflammatory parameters
measure: Serum Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL))
time frame: 3 months
description: Changes in inflammatory parameters
measure: Serum Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL))
time frame: 3 months
description: Changes in inflammatory parameters
measure: Serum C reactive protein (CRP) (nanogram per milliliter (ng/mL))
time frame: 3 months
description: Changes in inflammatory parameters
measure: Saliva Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL))
time frame: 3 months
description: Changes in inflammatory parameters
measure: Saliva C reactive protein (CRP) (nanogram per milliliter (ng/mL))
time frame: 3 months
description: Changes in inflammatory parameters
measure: Saliva Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL))
time frame: 3 months
description: Changes in inflammatory parameters
measure: Saliva Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL))
time frame: 3 months
description: Changes in inflammatory parameters
measure: Saliva Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL))
time frame: 3 months
description: Changes in inflammatory parameters
measure: Serum Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL))
time frame: 3 months
description: Changes in inflammatory parameters
measure: Plaque Index (PI)
time frame: 3 months
description: Change in clinical measures of chronic periodontitis
measure: Gingival Index (GI)
time frame: 3 months
description: Change in clinical measures of chronic periodontitis
measure: Bleeding on probing (BOP)
time frame: 3 months
description: Change in clinical measures of chronic periodontitis
measure: Clinical attachment loss(CAL)
time frame: 3 months
description: Change in clinical measures of chronic periodontitis
measure: Probing pocket depth (PD)
time frame: 3 months
description: Change in clinical measures of chronic periodontitis
arm group label: Experimental: Non-surgical periodontal therapy
arm group type: Experimental
description: Non-surgical periodontal therapy consisted of scaling and root planing and supportive periodontal therapy during 3 months
Intervention: Procedure: Non-surgical periodontal therapy
arm group label: Delayed non-surgical periodontal therapy
arm group type: Active Comparator
description: No periodontal treatment for 3 months
intervention type: Other
intervention name: Non-surgical periodontal therapy
description: Experimental: Non-surgical periodontal therapy (scaling and root planing) and supportive periodontal therapy
arm group label: Experimental: Non-surgical periodontal therapy
intervention type: Other
intervention name: Delayed non-surgical periodontal therapy
description: Delayed non-surgical periodontal therapy (scaling and root planing) after the 3 month visit
arm group label: Delayed non-surgical periodontal therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zeliha Betul Özsağır
role: Study Chair
affiliation: Bezmialem VU
facility: 
country: Turkey
citation: Loke W, Girvan T, Ingmundson P, Verrett R, Schoolfield J, Mealey BL. Investigating the association between obstructive sleep apnea and periodontitis. J Periodontol. 2015 Feb;86(2):232-43. doi: 10.1902/jop.2014.140229. Epub 2014 Oct 9.
PMID: 25299385
citation: Gamsiz-Isik H, Kiyan E, Bingol Z, Baser U, Ademoglu E, Yalcin F. Does Obstructive Sleep Apnea Increase the Risk for Periodontal Disease? A Case-Control Study. J Periodontol. 2017 May;88(5):443-449. doi: 10.1902/jop.2016.160365. Epub 2016 Nov 18.
PMID: 27858556
citation: DPTT study group; Engebretson S, Gelato M, Hyman L, Michalowicz BS, Schoenfeld E. Design features of the Diabetes and Periodontal Therapy Trial (DPTT): a multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes and chronic periodontitis. Contemp Clin Trials. 2013 Nov;36(2):515-26. doi: 10.1016/j.cct.2013.09.010. Epub 2013 Sep 27.
PMID: 24080100
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No