<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/NCT03241511</url>
  </required_header>
  <id_info>
    <org_study_id>16-111-1</org_study_id>
    <secondary_id>R21DK108076</secondary_id>
    <nct_id>NCT03241511</nct_id>
  </id_info>
  <brief_title>Novel PAradigm to Improve Inflammatory Burden in ESRD (rePAIR): A Pilot and Feasibility Randomized Controlled Trial</brief_title>
  <acronym>rePAIR</acronym>
  <official_title>Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UConn Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>UConn Health</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to assess repeated and ongoing oral care and the way it may&#xD;
      affect inflammation and quality of life in hemodialysis patients. Two treatment groups will&#xD;
      be compared:&#xD;
&#xD;
        -  1) ongoing and repeated gum disease therapy including deep tooth cleaning followed by&#xD;
           multiple appointments of maintenance&#xD;
&#xD;
        -  2) single session of gum disease therapy with only one session of deep tooth cleaning&#xD;
           Samples of blood will be obtained for study to examine the changes of inflammatory&#xD;
           substances in the blood as a result of the two different gum disease treatments. Also, a&#xD;
           14-question survey will be discussed with you to assess oral health related quality of&#xD;
           life (OHIP-14) and the way it is affected by oral care.&#xD;
&#xD;
      For this project, four dialysis centers will be randomly assigned to either of the treatment&#xD;
      groups #1 or #2 prior to your enrollment. For this purpose, there are two distinct consent&#xD;
      forms explaining the visits, procedures and risks of the two treatment groups #1 or #2. As a&#xD;
      result, all participants in the same dialysis center will belong to the same treatment group&#xD;
      (either #1 or #2) and presented with the corresponding consent form.&#xD;
&#xD;
      This dialysis center has been randomized to treatment group # 1; therefore you will receive&#xD;
      ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple&#xD;
      appointments of maintenance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">April 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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum CRP</measure>
    <time_frame>6 months</time_frame>
    <description>Inflammatory markers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probing depth PD</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical periodontal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment levels CAL</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical periodontal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OHIP-14</measure>
    <time_frame>6 months</time_frame>
    <description>Patient Centered Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum IL-6</measure>
    <time_frame>6 months</time_frame>
    <description>Inflammatory Marker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>F2 isoprostanes</measure>
    <time_frame>6 months</time_frame>
    <description>Oxidative Stress Marker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>isofurans</measure>
    <time_frame>6 months</time_frame>
    <description>Oxidative Stress Marker</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Chronic Periodontitis</condition>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic and repeated supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene). Outcomes will be assessed at 2-, 4-, and 6-months. Throughout the course of the study, additional dental needs will be addressed with immediate referral to the subject's general dentist or clinics at the University of Connecticut.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Control arm will receive only a single treatment session without maintenance sessions (see visit Table in Human Subject Protection section). Outcomes will be assessed at 2-, 4-, and 6-months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Test</intervention_name>
    <description>Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene).</description>
    <arm_group_label>Test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be referred by nephrologist&#xD;
&#xD;
          -  Patient must be diagnosed with ESRD and on Hemodialysis&#xD;
&#xD;
          -  life expectancy more than one year&#xD;
&#xD;
          -  at least 21 years of age&#xD;
&#xD;
          -  12 or more teeth&#xD;
&#xD;
          -  must meet the Periodontal diagnosis criteria (The diagnosis of periodontitis is based&#xD;
             on the definition of moderate periodontitis with at least 2 sites with CAL≥4mm or at&#xD;
             least 2 sites with PD≥5mm not on the same tooth (Page and Eke 2007).)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anticipating a kidney transplant&#xD;
&#xD;
          -  AIDS&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Poor adherence to hemodialysis&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Currently prescribed anti-inflammatory medication&#xD;
&#xD;
          -  Temporary catheter for dialysis access&#xD;
&#xD;
          -  Gum disease treatment within the last year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Effie Ioannidou, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>UConn Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Connecticut Health Center</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030-1710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Trivedi R, Fares G, Nunez VB, Campbell R, Clement M, Burleson J, Himmelfarb J, Ioannidou E. Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial. Trials. 2018 Jul 11;19(1):370. doi: 10.1186/s13063-018-2760-y.</citation>
    <PMID>29996883</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>January 29, 2021</last_update_submitted>
  <last_update_submitted_qc>January 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UConn Health</investigator_affiliation>
    <investigator_full_name>Efthimia Ioannidou</investigator_full_name>
    <investigator_title>Associate Professor, Director, DCRC, School of Dental Medicine</investigator_title>
  </responsible_party>
  <keyword>Periodontitis, End Stage Renal Disease, Periodontal treatment</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>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Once the study is completed, the data will be available without cost to researchers. As part of the registration process, users must agree to the conditions of use governing access to the public release data (e.g., data destruction after analyses are complete, proper acknowledgement of data resources). Data will be provided at no cost and all data will be de-identified prior to sharing.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data will available after the completion of the study</ipd_time_frame>
    <ipd_access_criteria>As part of the registration process, users must agree to the conditions of use governing access to the public release data (e.g., data destruction after analyses are complete, proper acknowledgement of data resources). Data will be provided at no cost and all data will be de-identified prior to sharing.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03241511/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03241511
org study id: 16-111-1
secondary id: R21DK108076
nct id: NCT03241511
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this project is to assess repeated and ongoing oral care and the way it may
      affect inflammation and quality of life in hemodialysis patients. Two treatment groups will
      be compared:

        -  1) ongoing and repeated gum disease therapy including deep tooth cleaning followed by
           multiple appointments of maintenance

        -  2) single session of gum disease therapy with only one session of deep tooth cleaning
           Samples of blood will be obtained for study to examine the changes of inflammatory
           substances in the blood as a result of the two different gum disease treatments. Also, a
           14-question survey will be discussed with you to assess oral health related quality of
           life (OHIP-14) and the way it is affected by oral care.

      For this project, four dialysis centers will be randomly assigned to either of the treatment
      groups #1 or #2 prior to your enrollment. For this purpose, there are two distinct consent
      forms explaining the visits, procedures and risks of the two treatment groups #1 or #2. As a
      result, all participants in the same dialysis center will belong to the same treatment group
      (either #1 or #2) and presented with the corresponding consent form.

      This dialysis center has been randomized to treatment group # 1; therefore you will receive
      ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple
      appointments of maintenance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Serum CRP
time frame: 6 months
description: Inflammatory markers
measure: Probing depth PD
time frame: 6 months
description: Clinical periodontal outcome
measure: Clinical attachment levels CAL
time frame: 6 months
description: Clinical periodontal outcome
measure: OHIP-14
time frame: 6 months
description: Patient Centered Outcome
measure: Serum IL-6
time frame: 6 months
description: Inflammatory Marker
measure: F2 isoprostanes
time frame: 6 months
description: Oxidative Stress Marker
measure: isofurans
time frame: 6 months
description: Oxidative Stress Marker
arm group label: Test
arm group type: Experimental
description: Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic and repeated supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene). Outcomes will be assessed at 2-, 4-, and 6-months. Throughout the course of the study, additional dental needs will be addressed with immediate referral to the subject's general dentist or clinics at the University of Connecticut.
arm group label: Control
arm group type: No Intervention
description: The Control arm will receive only a single treatment session without maintenance sessions (see visit Table in Human Subject Protection section). Outcomes will be assessed at 2-, 4-, and 6-months.
intervention type: Other
intervention name: Test
description: Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene).
arm group label: Test
criteria: 
gender: All
gender based: Yes
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Effie Ioannidou, DDS, MS
role: Principal Investigator
affiliation: UConn Health
facility: 
country: United States
citation: Trivedi R, Fares G, Nunez VB, Campbell R, Clement M, Burleson J, Himmelfarb J, Ioannidou E. Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial. Trials. 2018 Jul 11;19(1):370. doi: 10.1186/s13063-018-2760-y.
PMID: 29996883
responsible party type: Principal Investigator
investigator affiliation: UConn Health
investigator full name: Efthimia Ioannidou
investigator title: Associate Professor, Director, DCRC, School of Dental Medicine
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
sharing ipd: Yes
ipd description: Once the study is completed, the data will be available without cost to researchers. As part of the registration process, users must agree to the conditions of use governing access to the public release data (e.g., data destruction after analyses are complete, proper acknowledgement of data resources). Data will be provided at no cost and all data will be de-identified prior to sharing.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data will available after the completion of the study
ipd access criteria: As part of the registration process, users must agree to the conditions of use governing access to the public release data (e.g., data destruction after analyses are complete, proper acknowledgement of data resources). Data will be provided at no cost and all data will be de-identified prior to sharing.
provided document: 