<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/NCT03244943</url>
  </required_header>
  <id_info>
    <org_study_id>37030514.7.0000.5419</org_study_id>
    <nct_id>NCT03244943</nct_id>
  </id_info>
  <brief_title>Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy</brief_title>
  <official_title>Effects of Non-surgical Periodontal Treatment on the Gingival Crevicular Fluid Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Aim: This study evaluated the effects of non-surgical periodontal therapy (NSPT) on the&#xD;
      cytokine profile and the correlation to clinical parameters of patients undergoing&#xD;
      chemotherapy for breast cancer.&#xD;
&#xD;
      Materials and methods: 40 patients were allocated: periodontitis patients (P) (n=20) and&#xD;
      breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing&#xD;
      depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding on probing (BOP) and&#xD;
      levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival&#xD;
      crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under&#xD;
      local anesthesia. On average, the treatment of the entire oral cavity was completed within&#xD;
      four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist&#xD;
      (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices&#xD;
      (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with&#xD;
      multilaminated drills.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 1, 2015</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 12, 2016</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>40 patients were allocated: periodontitis patients (P) (n=20) and breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding of probing (BOP) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cytokines</measure>
    <time_frame>baseline, 45 days, 180 days</time_frame>
    <description>Cytokine levels and changes before and after post treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of cytokines</measure>
    <time_frame>baseline, 45 days, 180 days</time_frame>
    <description>cytokine levels between parameters clinical</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Mammary Neoplasm, Human</condition>
  <condition>Periodontal Diseases</condition>
  <condition>Chemotherapy Effect</condition>
  <arm_group>
    <arm_group_label>Non surgical periodontal treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non surgical periodontal Treatment</intervention_name>
    <description>The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia. On average, the treatment of the entire oral cavity was completed within four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with multilaminated drills.</description>
    <arm_group_label>Non surgical periodontal treatment</arm_group_label>
    <other_name>scaling and root planning (SRP) under local anesthesia.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients were diagnosed with periodontitis (P) The inclusion criteria were:Loss of&#xD;
             clinical insertion (CAL) ≥ 5mm and PD probing depth ≥ 6mm in ≥ 30% of sites; ≥20&#xD;
             teeth; radiographic bone loss that extends to the middle level of the root; presence&#xD;
             of supragingival and subgingival calculus according to the severity of periodontal&#xD;
             damage. Grade B was assessed indirectly, considering radiographic bone loss in the&#xD;
             tooth most affected by dentition as a function of age (0.25 to 1.0).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) scaling and root planning or antibiotic treatment in the previous 6 months; 2)&#xD;
             systemic diseases that could affect the progression of periodontitis (e.g., diabetes,&#xD;
             hypertension, cardiovascular diseases); 3) extensive prosthetic involvement; 4)&#xD;
             long-term administration of anti-inﬂammatory medication; 6) smokers and former&#xD;
             smokers; 7) pregnancy or lactation; 8) orthodontic therapy; 9) use of mouth rinses&#xD;
             containing antimicrobials in the preceding 2 months; 10) patients had previously&#xD;
             received chemotherapy or radiotherapy; 11) patients with metastasis and/or patients&#xD;
             with neoadjuvant chemotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women with cancer and without breast cancer between 35 and 70 years of age</gender_description>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Kelly Rocio Vargas Villafuerte</investigator_full_name>
    <investigator_title>Master of periodontics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mammary Neoplasms, Animal</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De- identified individual participant for all primary and secundary outcome measures will be made available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>6 months of study completion</ipd_time_frame>
    <ipd_access_criteria>data access request will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement</ipd_access_criteria>
  </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/NCT03244943
org study id: 37030514.7.0000.5419
nct id: NCT03244943
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aim: This study evaluated the effects of non-surgical periodontal therapy (NSPT) on the
      cytokine profile and the correlation to clinical parameters of patients undergoing
      chemotherapy for breast cancer.

      Materials and methods: 40 patients were allocated: periodontitis patients (P) (n=20) and
      breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing
      depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding on probing (BOP) and
      levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival
      crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.
The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under
      local anesthesia. On average, the treatment of the entire oral cavity was completed within
      four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist
      (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices
      (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with
      multilaminated drills.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 40 patients were allocated: periodontitis patients (P) (n=20) and breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding of probing (BOP) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.
primary purpose: Treatment
masking: None (Open Label)
measure: Cytokines
time frame: baseline, 45 days, 180 days
description: Cytokine levels and changes before and after post treatment
measure: Correlation of cytokines
time frame: baseline, 45 days, 180 days
description: cytokine levels between parameters clinical
arm group label: Non surgical periodontal treatment
arm group type: Other
description: The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia.
intervention type: Procedure
intervention name: Non surgical periodontal Treatment
description: The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia. On average, the treatment of the entire oral cavity was completed within four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with multilaminated drills.
arm group label: Non surgical periodontal treatment
other name: scaling and root planning (SRP) under local anesthesia.
criteria: 
gender: Female
gender based: Yes
gender description: Women with cancer and without breast cancer between 35 and 70 years of age
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Kelly Rocio Vargas Villafuerte
investigator title: Master of periodontics
mesh term: Mammary Neoplasms, Animal
mesh term: Breast Neoplasms
mesh term: Periodontal Diseases
sharing ipd: Yes
ipd description: De- identified individual participant for all primary and secundary outcome measures will be made available
ipd info type: Study Protocol
ipd time frame: 6 months of study completion
ipd access criteria: data access request will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement