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/NCT06029283</url>
    </required_header>
    <id_info>
      <org_study_id>HP-00106795</org_study_id>
      <nct_id>NCT06029283</nct_id>
    </id_info>
    <brief_title>Effect on Oral-cardio Health From Dietary Nitrate Loaded Functional Gum</brief_title>
    <official_title>Effect on Oral-cardio Health From Dietary Nitrate Loaded Functional Gum</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Maryland, Baltimore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Maryland, Baltimore</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 purpose of this research is to determine the effects of a chewing gum containing dietary&#xD;
        nitrate to your gingival and heart health. Dietary nitrates are commonly found in leafy&#xD;
        vegetables and beets. The information learned from the study may help us further understand&#xD;
        the interconnection of oral health and heart health. The study is looking for individuals who&#xD;
        present with mild to moderate gum irritation or bleeding.&#xD;
  &#xD;
        In the study participants will be randomized into either a group that will use a chewing gum&#xD;
        containing dietary nitrate, or use a placebo chewing gum during a three-week period.&#xD;
  &#xD;
        Participants in the study will have a simple gingival exam, x-rays if needed, and small&#xD;
        samples of saliva and blood collected. All participants will also undergo a routine tooth&#xD;
        cleaning. Participants will be asked to breathe in a tube to sample the levels of nitric&#xD;
        oxide. Finally, participants will have their heart health measured with a device that is like&#xD;
        a blood pressure cuff.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of the project is to characterize, in subjects with gingival inflammation, the&#xD;
        effect of a prebiotic dietary nitrate formulated chewing gum on the oral microbiome. In order&#xD;
        to assess this, we will observe gingival health and parameters related to vascular health:&#xD;
  &#xD;
        We are testing the hypothesize that short term use of functional gum will have improved&#xD;
        inflammatory measures of the gingiva and beneficial cardiovascular impact. We endeavor to&#xD;
        discover if any observed changes to oral and cardiovascular measures may be associated to&#xD;
        changes to oral microbiome composition.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 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>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gingival inflammation</measure>
      <time_frame>0 and 21 days</time_frame>
      <description>Gingival index or similar data collected.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Microbiome profile</measure>
      <time_frame>0 and 21 days</time_frame>
      <description>salivary sample collected</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood vessel elasticity</measure>
      <time_frame>0 and 21 days</time_frame>
      <description>CV profiler device used</description>
    </primary_outcome>
    <primary_outcome>
      <measure>nitric oxide</measure>
      <time_frame>0 and 21 days</time_frame>
      <description>Breathalyzer type test</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Gingivitis</condition>
    <condition>Cardiovascular Diseases</condition>
    <arm_group>
      <arm_group_label>Placebo arm of non-dietary nitrate gum</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo gum with no dietary nitrate</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Test arm of dietary nitrate containing gum</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Functional gum with dietary nitrate</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>dietary nitrate</intervention_name>
      <description>dietary nitrate in a chewing gum delivery vehicle</description>
      <arm_group_label>Test arm of dietary nitrate containing gum</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo chewing gum</intervention_name>
      <description>placebo chewing gum</description>
      <arm_group_label>Placebo arm of non-dietary nitrate gum</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Adult subjects with mild to moderate gingivitis, as defined with a MGI score of at least&#xD;
          2.0 Subjects must have a minimum of 20 natural teeth Subjects must able to chew gum&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Significant alveolar bone loss (&gt;3.0 mm CEJ to bone) Requirement for antibiotic&#xD;
          pre-medication prior to dental procedures Systemic antibiotic use in past 14 days to&#xD;
          current. Use of anti-inflammatory (NSAIDs) or in past 14 days Use of anticoagulant therapy&#xD;
          or in past 14 days. Current smokers Pregnancy Use of any oral rinses such as, but not&#xD;
          limited to chlorhexidine, essential oils, cetylpyridinium chloride during the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gingivitis</mesh_term>
      <mesh_term>Cardiovascular Diseases</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/NCT06029283
  org study id: HP-00106795
  nct id: NCT06029283
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this research is to determine the effects of a chewing gum containing dietary
        nitrate to your gingival and heart health. Dietary nitrates are commonly found in leafy
        vegetables and beets. The information learned from the study may help us further understand
        the interconnection of oral health and heart health. The study is looking for individuals who
        present with mild to moderate gum irritation or bleeding.
  
        In the study participants will be randomized into either a group that will use a chewing gum
        containing dietary nitrate, or use a placebo chewing gum during a three-week period.
  
        Participants in the study will have a simple gingival exam, x-rays if needed, and small
        samples of saliva and blood collected. All participants will also undergo a routine tooth
        cleaning. Participants will be asked to breathe in a tube to sample the levels of nitric
        oxide. Finally, participants will have their heart health measured with a device that is like
        a blood pressure cuff.
  The purpose of the project is to characterize, in subjects with gingival inflammation, the
        effect of a prebiotic dietary nitrate formulated chewing gum on the oral microbiome. In order
        to assess this, we will observe gingival health and parameters related to vascular health:
  
        We are testing the hypothesize that short term use of functional gum will have improved
        inflammatory measures of the gingiva and beneficial cardiovascular impact. We endeavor to
        discover if any observed changes to oral and cardiovascular measures may be associated to
        changes to oral microbiome composition.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Gingival inflammation
  time frame: 0 and 21 days
  description: Gingival index or similar data collected.
  measure: Microbiome profile
  time frame: 0 and 21 days
  description: salivary sample collected
  measure: Blood vessel elasticity
  time frame: 0 and 21 days
  description: CV profiler device used
  measure: nitric oxide
  time frame: 0 and 21 days
  description: Breathalyzer type test
  arm group label: Placebo arm of non-dietary nitrate gum
  arm group type: Placebo Comparator
  description: Placebo gum with no dietary nitrate
  arm group label: Test arm of dietary nitrate containing gum
  arm group type: Experimental
  description: Functional gum with dietary nitrate
  intervention type: Dietary Supplement
  intervention name: dietary nitrate
  description: dietary nitrate in a chewing gum delivery vehicle
  arm group label: Test arm of dietary nitrate containing gum
  intervention type: Other
  intervention name: Placebo chewing gum
  description: placebo chewing gum
  arm group label: Placebo arm of non-dietary nitrate gum
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Gingivitis
  mesh term: Cardiovascular Diseases
  sharing ipd: No