<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/NCT04462341</url>
  </required_header>
  <id_info>
    <org_study_id>29DRIOH2019</org_study_id>
    <nct_id>NCT04462341</nct_id>
  </id_info>
  <brief_title>Efficacy of an Oral Hygiene Implant Protocol</brief_title>
  <official_title>Efficacy of an Oral Hygiene Regimen on Implant Supported, Removable Complete Denture: Effect on Gingival Tissue and Prosthesis: A Proof of Concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Water Pik, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Water Pik, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the effectiveness of cleaning around implants that hold a&#xD;
      full denture in the mouth. Different oral hygiene protocols will be compared. Areas to&#xD;
      measure are gum tissue color and consistency, bleeding and cleanliness. A questionnaire will&#xD;
      be provided at the end of the study. This is a proof of concept study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this proof of concept study is to evaluate the effect of an oral hygiene regimen&#xD;
      of manual brushing and water flossing on implant retained removable complete dentures. This&#xD;
      is a randomized, two arm clinical trial that will compare the traditional oral hygiene&#xD;
      regimen to the experimental regimen. Data will be evaluated at baseline, 3 weeks and 6 weeks.&#xD;
      Photographs of the tissue and denture will be taken.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 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>Supportive Care</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>6 weeks</time_frame>
    <description>Binary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>6 weeks</time_frame>
    <description>mm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Peri-implant Mucositis</condition>
  <arm_group>
    <arm_group_label>Manual brushing only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants brushed with a manual toothbrush and fluoridated toothpaste twice a day for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual brushing + water flossing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants brush twice a day and water flossed once a day for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Water Flosser</intervention_name>
    <description>Device that uses water under pressure to clean around teeth and under the gums</description>
    <arm_group_label>Manual brushing + water flossing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manual Toothbrush</intervention_name>
    <description>Plastic handle with nylon bristles to clean teeth</description>
    <arm_group_label>Manual brushing + water flossing</arm_group_label>
    <arm_group_label>Manual brushing only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have a maxillary and/or mandibular implant supported, removable complete denture that&#xD;
             is supported by at least 2 implants in good, serviceable condition&#xD;
&#xD;
          -  Good general health, with no diseases which could impact periodontal health&#xD;
&#xD;
          -  able to read and understand English&#xD;
&#xD;
          -  willing to return for all appointments&#xD;
&#xD;
          -  at least 30% BOP&#xD;
&#xD;
          -  probing depths less or equal to 5mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who are currently pregnant&#xD;
&#xD;
          -  mobility of implant&#xD;
&#xD;
          -  subjects who have diabetes&#xD;
&#xD;
          -  subjects who smoke&#xD;
&#xD;
          -  subjects with any serious medical condition which the investigator feels may impact&#xD;
             participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerard Kugel, DDS</last_name>
    <role>Study Chair</role>
    <affiliation>Tufts School of Dental Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts School of Dental Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2021</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>Mucositis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04462341
org study id: 29DRIOH2019
nct id: NCT04462341
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study is designed to evaluate the effectiveness of cleaning around implants that hold a
      full denture in the mouth. Different oral hygiene protocols will be compared. Areas to
      measure are gum tissue color and consistency, bleeding and cleanliness. A questionnaire will
      be provided at the end of the study. This is a proof of concept study.
The aim of this proof of concept study is to evaluate the effect of an oral hygiene regimen
      of manual brushing and water flossing on implant retained removable complete dentures. This
      is a randomized, two arm clinical trial that will compare the traditional oral hygiene
      regimen to the experimental regimen. Data will be evaluated at baseline, 3 weeks and 6 weeks.
      Photographs of the tissue and denture will be taken.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Bleeding on probing
time frame: 6 weeks
description: Binary
measure: Probing depth
time frame: 6 weeks
description: mm
arm group label: Manual brushing only
arm group type: Active Comparator
description: Participants brushed with a manual toothbrush and fluoridated toothpaste twice a day for 6 weeks
arm group label: Manual brushing + water flossing
arm group type: Experimental
description: Participants brush twice a day and water flossed once a day for 6 weeks.
intervention type: Device
intervention name: Water Flosser
description: Device that uses water under pressure to clean around teeth and under the gums
arm group label: Manual brushing + water flossing
intervention type: Device
intervention name: Manual Toothbrush
description: Plastic handle with nylon bristles to clean teeth
arm group label: Manual brushing + water flossing
arm group label: Manual brushing only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gerard Kugel, DDS
role: Study Chair
affiliation: Tufts School of Dental Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mucositis