<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/NCT03237624</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00073354</org_study_id>
    <nct_id>NCT03237624</nct_id>
  </id_info>
  <brief_title>Functional Chewing Gum in Reduction of Gingival Inflammation</brief_title>
  <official_title>Use of a Functional Chewing Gum in Reduction of Gingival Inflammation</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>
    <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>
      The aim of this prospective randomized 3-month double-blinded single center study is to&#xD;
      determine whether a chewing gum device with food additive chitosan, will aid in reducing&#xD;
      gingival inflammation by supplementing traditional tooth brushing and flossing measures.&#xD;
      Patients with mild to moderate gingivitis will be identified and enrolled in this&#xD;
      investigation. All enrolled subjects will receive baseline oral hygiene brushing instructions&#xD;
      and a baseline clinical examination of the gingiva. The test group will utilize the test&#xD;
      chewing gum three times a day for a minimum 20-30 minutes duration; the control group will&#xD;
      receive a placebo gum and use it in a similar manner. We will examine whether daily use of a&#xD;
      functional chewing gum enhances improvements to brushing and flossing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Periodontal disease remains a prevalent and preventable disease in man. Plaque bacterial&#xD;
      biofilm remains the primary etiologic agent of disease; colonization of non-shedding tooth&#xD;
      surfaces greatly contributes to initiation and progression of gingivitis, for example.&#xD;
      Although there are currently available chemotherapeutic agents to supplement daily oral&#xD;
      hygiene measures, one continuous issue is patient compliance. Chewing gum represents a unique&#xD;
      delivery device for not only drugs and other agents, but food additives that might aid in&#xD;
      reducing bacteria plaque colonization on tooth surfaces. For example, chitosan and&#xD;
      chitosan-related food additive preparations have been shown to have some antimicrobial-like&#xD;
      properties, possibly in the disruption of bacterial colonization (not -cidal).&#xD;
&#xD;
      NOTE: ALL INGREDIENTS of the &quot;test&quot; chewing gum, and the placebo chewing gum, are generally&#xD;
      regarded as safe (&quot;GRAS&quot; label by the Food and Drug Administration), as they are common food&#xD;
      components. For example, chitosan is listed in the GRAS database&#xD;
      (https://www.accessdata.fda.gov/scripts/fdcc/?set=SCOGS). See item GRN No. 397.&#xD;
&#xD;
      This study aims to determine whether adjunctive use of functional chewing gum will improve&#xD;
      gingival inflammation status-retaining clinical gains initiated by professional tooth&#xD;
      cleaning and at home brushing over a 12 week period in gingivitis patients.&#xD;
&#xD;
      Eligibility criteria and outcome measures are described in the next section.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gum inflammation change</measure>
    <time_frame>Change in color of gingiva from baseline to 12 weeks</time_frame>
    <description>Measure the color of gingiva - use Gingiva Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plaque levels (on teeth) change</measure>
    <time_frame>Change in plaque level from baseline to 12 weeks</time_frame>
    <description>Measure plaque using Plaque Index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Gingivitis</condition>
  <arm_group>
    <arm_group_label>Functional chewing gum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects given as intervention functional chewing gum device to supplement oral hygiene practices. Functional gum contains chitosan which is a food additive or generally recognized as safe food product. Individuals will use this gum 20 to 30 minutes three times per day. Subjects will brush and floss normally twice a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control chewing gum</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects given control gum to supplement oral hygiene practices. Placebo gum does not contain any active ingredients. Individuals will use this gum 20 to 30 minutes three times per day. Subjects will brush and floss normally twice a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Functional Chitosan Chewing Gum</intervention_name>
    <description>Chitosan and chitosan-related preparations have been shown to have some antimicrobial properties, possibly in the disruption of bacterial colonization. It is thought that as a component of a functional chewing gum this will supplement in the removal of daily build up of dental plaque on tooth surfaces.</description>
    <arm_group_label>Functional chewing gum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control Chewing Gum</intervention_name>
    <description>Control chewing gum device does not have food additive chitosan in its composition.</description>
    <arm_group_label>Control chewing gum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Oral hygiene measures</intervention_name>
    <description>Patients will be given instructions on how to brush and floss routinely (twice per day)</description>
    <arm_group_label>Control chewing gum</arm_group_label>
    <arm_group_label>Functional chewing gum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild-moderate gingivitis&#xD;
&#xD;
          -  Minimum of 20 natural teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant alveolar bone loss as evidenced by Bite-wings (&gt;3.0 mm cementoenamel&#xD;
             junction to bone)&#xD;
&#xD;
          -  Requirement for antibiotic pre-medication prior to dental procedures&#xD;
&#xD;
          -  Systemic antibiotic use in past 14 days to current.&#xD;
&#xD;
          -  Use of oral contraceptives&#xD;
&#xD;
          -  Use of anti-inflammatory (NSAIDs) or in past 14 days.&#xD;
&#xD;
          -  Use of anticoagulant therapy or in past 14 days.&#xD;
&#xD;
          -  Poorly controlled diabetes (HbA1c &gt; 7.9%)*&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Use of any oral rinses such as, but not limited to chlorhexidine, essential oils,&#xD;
             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>
  <overall_official>
    <last_name>Harlan Shiau, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMSOD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Maryland School of Dentistry</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kaur S, Dhillon GS. The versatile biopolymer chitosan: potential sources, evaluation of extraction methods and applications. Crit Rev Microbiol. 2014 May;40(2):155-75. doi: 10.3109/1040841X.2013.770385. Epub 2013 Mar 14.</citation>
    <PMID>23488873</PMID>
  </reference>
  <reference>
    <citation>Machul A, Mikolajczyk D, Regiel-Futyra A, Heczko PB, Strus M, Arruebo M, Stochel G, Kyziol A. Study on inhibitory activity of chitosan-based materials against biofilm producing Pseudomonas aeruginosa strains. J Biomater Appl. 2015 Sep;30(3):269-78. doi: 10.1177/0885328215578781. Epub 2015 Apr 8.</citation>
    <PMID>25855683</PMID>
  </reference>
  <reference>
    <citation>Li Y, Lee S, Hujoel P, Su M, Zhang W, Kim J, Zhang YP, DeVizio W. Prevalence and severity of gingivitis in American adults. Am J Dent. 2010 Feb;23(1):9-13.</citation>
    <PMID>20437720</PMID>
  </reference>
  <reference>
    <citation>Simons D, Beighton D, Kidd EA, Collier FI. The effect of xylitol and chlorhexidine acetate/xylitol chewing gums on plaque accumulation and gingival inflammation. J Clin Periodontol. 1999 Jun;26(6):388-91. doi: 10.1034/j.1600-051x.1999.260609.x.</citation>
    <PMID>10382579</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Harlan Shiau</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>gingivitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chitosan</mesh_term>
  </intervention_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/NCT03237624
org study id: HP-00073354
nct id: NCT03237624
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this prospective randomized 3-month double-blinded single center study is to
      determine whether a chewing gum device with food additive chitosan, will aid in reducing
      gingival inflammation by supplementing traditional tooth brushing and flossing measures.
      Patients with mild to moderate gingivitis will be identified and enrolled in this
      investigation. All enrolled subjects will receive baseline oral hygiene brushing instructions
      and a baseline clinical examination of the gingiva. The test group will utilize the test
      chewing gum three times a day for a minimum 20-30 minutes duration; the control group will
      receive a placebo gum and use it in a similar manner. We will examine whether daily use of a
      functional chewing gum enhances improvements to brushing and flossing.
Periodontal disease remains a prevalent and preventable disease in man. Plaque bacterial
      biofilm remains the primary etiologic agent of disease; colonization of non-shedding tooth
      surfaces greatly contributes to initiation and progression of gingivitis, for example.
      Although there are currently available chemotherapeutic agents to supplement daily oral
      hygiene measures, one continuous issue is patient compliance. Chewing gum represents a unique
      delivery device for not only drugs and other agents, but food additives that might aid in
      reducing bacteria plaque colonization on tooth surfaces. For example, chitosan and
      chitosan-related food additive preparations have been shown to have some antimicrobial-like
      properties, possibly in the disruption of bacterial colonization (not -cidal).

      NOTE: ALL INGREDIENTS of the "test" chewing gum, and the placebo chewing gum, are generally
      regarded as safe ("GRAS" label by the Food and Drug Administration), as they are common food
      components. For example, chitosan is listed in the GRAS database
      (https://www.accessdata.fda.gov/scripts/fdcc/?set=SCOGS). See item GRN No. 397.

      This study aims to determine whether adjunctive use of functional chewing gum will improve
      gingival inflammation status-retaining clinical gains initiated by professional tooth
      cleaning and at home brushing over a 12 week period in gingivitis patients.

      Eligibility criteria and outcome measures are described in the next section.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Gum inflammation change
time frame: Change in color of gingiva from baseline to 12 weeks
description: Measure the color of gingiva - use Gingiva Index
measure: Plaque levels (on teeth) change
time frame: Change in plaque level from baseline to 12 weeks
description: Measure plaque using Plaque Index
arm group label: Functional chewing gum
arm group type: Experimental
description: Subjects given as intervention functional chewing gum device to supplement oral hygiene practices. Functional gum contains chitosan which is a food additive or generally recognized as safe food product. Individuals will use this gum 20 to 30 minutes three times per day. Subjects will brush and floss normally twice a day.
arm group label: Control chewing gum
arm group type: Placebo Comparator
description: Subjects given control gum to supplement oral hygiene practices. Placebo gum does not contain any active ingredients. Individuals will use this gum 20 to 30 minutes three times per day. Subjects will brush and floss normally twice a day.
intervention type: Device
intervention name: Functional Chitosan Chewing Gum
description: Chitosan and chitosan-related preparations have been shown to have some antimicrobial properties, possibly in the disruption of bacterial colonization. It is thought that as a component of a functional chewing gum this will supplement in the removal of daily build up of dental plaque on tooth surfaces.
arm group label: Functional chewing gum
intervention type: Device
intervention name: Control Chewing Gum
description: Control chewing gum device does not have food additive chitosan in its composition.
arm group label: Control chewing gum
intervention type: Behavioral
intervention name: Oral hygiene measures
description: Patients will be given instructions on how to brush and floss routinely (twice per day)
arm group label: Control chewing gum
arm group label: Functional chewing gum
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harlan Shiau, DDS
role: Principal Investigator
affiliation: UMSOD
facility: 
country: United States
citation: Kaur S, Dhillon GS. The versatile biopolymer chitosan: potential sources, evaluation of extraction methods and applications. Crit Rev Microbiol. 2014 May;40(2):155-75. doi: 10.3109/1040841X.2013.770385. Epub 2013 Mar 14.
PMID: 23488873
citation: Machul A, Mikolajczyk D, Regiel-Futyra A, Heczko PB, Strus M, Arruebo M, Stochel G, Kyziol A. Study on inhibitory activity of chitosan-based materials against biofilm producing Pseudomonas aeruginosa strains. J Biomater Appl. 2015 Sep;30(3):269-78. doi: 10.1177/0885328215578781. Epub 2015 Apr 8.
PMID: 25855683
citation: Li Y, Lee S, Hujoel P, Su M, Zhang W, Kim J, Zhang YP, DeVizio W. Prevalence and severity of gingivitis in American adults. Am J Dent. 2010 Feb;23(1):9-13.
PMID: 20437720
citation: Simons D, Beighton D, Kidd EA, Collier FI. The effect of xylitol and chlorhexidine acetate/xylitol chewing gums on plaque accumulation and gingival inflammation. J Clin Periodontol. 1999 Jun;26(6):388-91. doi: 10.1034/j.1600-051x.1999.260609.x.
PMID: 10382579
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Harlan Shiau
investigator title: Clinical Associate Professor
mesh term: Gingivitis
mesh term: Inflammation
mesh term: Chitosan
sharing ipd: No