<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/NCT03243591</url>
  </required_header>
  <id_info>
    <org_study_id>388-17-EP</org_study_id>
    <nct_id>NCT03243591</nct_id>
  </id_info>
  <brief_title>Impact of Oral Hygiene Gels on Peri-implant Mucositis</brief_title>
  <official_title>Impact of Oral Hygiene Gels on Peri-implant Mucositis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</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>
      Peri-implant mucositis is abnormal inflammation occurring around dental implants, increasing&#xD;
      the risk of loss of bone support. The purpose of this study is to evaluate the impact of&#xD;
      brushing the bacterial biofilm at the implant-mucosa interface with one of two,&#xD;
      commercially-available dental gels over a 30-day period on amounts of biofilm and indices of&#xD;
      mucosal inflammation. Adult subjects (&gt; 19 years old) will be invited to consent if they have&#xD;
      at least one dental implant displaying mucositis defined as Gingivitis Index of 2 or greater,&#xD;
      no dental treatment in the previous 30 days, capable of normal toothbrushing, and no Sjogrens&#xD;
      disease, immunodeficiency, pregnancy, poorly-controlled diabetes, or regular systemic&#xD;
      antibiotics, anti-inflammatory drugs or immune suppressants. Ten patients in each tooth gel&#xD;
      group will be instructed to apply a pea size amount of dentifrice brushing the implant and&#xD;
      mucosa 2 times daily for 30 days. Baseline and 30-day examinations will be conducted to&#xD;
      record Gingivitis Index, Plaque Index, probing depths, clinical photo, crevicular fluid, and&#xD;
      adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a prospective, randomized, controlled, double-blind, single center study. Once&#xD;
      eligibility has been determined, up to 21 Subjects will be enrolled. Subjects will be&#xD;
      randomly assigned in a 1:1 ratio to treat with either Livionex Dental Gel (a plaque control&#xD;
      gel that is safe for ingestion and is currently sold by Livionex Inc.) or the control&#xD;
      Aquafresh toothpaste. Each study visit will last 30 minutes.&#xD;
&#xD;
      The soft tissue around the dental implant will be observed at baseline and after 30 days for&#xD;
      inflammation using the Gingivitis Index and probed with a UNC 15 periodontol probe for pocket&#xD;
      depth and bleeding. A photograph will be taken of the most inflamed side of the implant.&#xD;
      Plaque will be stained with oral hygiene staining rinse and evaluated for Plaque Index.&#xD;
      Finally, a paper strip will be inserted between the gingiva and implant on facial and lingual&#xD;
      sides for 30 seconds each.&#xD;
&#xD;
      GINGIVITIS INDEX: Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation, 1 =&#xD;
      Mild inflammation slight change in color and little change in texture 2 = Moderate&#xD;
      inflammation moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon&#xD;
      probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous&#xD;
      bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around&#xD;
      the tooth) scored.&#xD;
&#xD;
      PLAQUE INDEX Using Quigley Staining Hein Method with Turesky Modification:Units on a scale 0&#xD;
      to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band&#xD;
      of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two&#xD;
      thirds of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque&#xD;
      score = sum of all scores divided by the number of sites (teeth) scored.&#xD;
&#xD;
      Each patients will be instructed to brush around the implant with a pea size amount of&#xD;
      dentifrice provided, twice daily for 30 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2018</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>prospective, randomized, controlled, double-blind, single center</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Gels are in coded opaque tubes created at the manufacturer</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Gingival Index</measure>
    <time_frame>30 days</time_frame>
    <description>Level of clinical inflammation around dental implant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plaque Index</measure>
    <time_frame>30 days</time_frame>
    <description>Amount of biofilm around dental implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crevicular Fluid Biomarkers</measure>
    <time_frame>30 days</time_frame>
    <description>Fluid from around implant measured for inflammation markers with ELISA</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Mucositis</condition>
  <arm_group>
    <arm_group_label>Livionex gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brushing area of mucositis with Livionex gel for 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aquafresh gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brushing area of mucositis with Aquafresh gel for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Livionex gel</intervention_name>
    <description>Brushing area of mucositis with gel</description>
    <arm_group_label>Livionex gel</arm_group_label>
    <other_name>Aquafresh gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aquafresh gel</intervention_name>
    <description>Aquafresh gel</description>
    <arm_group_label>Aquafresh gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history of 5 mm+ pocket bleeding on probing around implant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dental treatment of implant in previous 30 days&#xD;
&#xD;
          -  Sjogrens disease&#xD;
&#xD;
          -  immunodeficiencies (e.g. AIDS)&#xD;
&#xD;
          -  poorly-controlled diabetes&#xD;
&#xD;
          -  regular use of antibiotics, anti-inflammatory drugs or immune suppressants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Nebraska Medical Center College of Dentistry</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68583</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</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 9, 2017</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>Richard Reinhardt</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mucositis</mesh_term>
  </condition_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/NCT03243591
org study id: 388-17-EP
nct id: NCT03243591
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Peri-implant mucositis is abnormal inflammation occurring around dental implants, increasing
      the risk of loss of bone support. The purpose of this study is to evaluate the impact of
      brushing the bacterial biofilm at the implant-mucosa interface with one of two,
      commercially-available dental gels over a 30-day period on amounts of biofilm and indices of
      mucosal inflammation. Adult subjects (> 19 years old) will be invited to consent if they have
      at least one dental implant displaying mucositis defined as Gingivitis Index of 2 or greater,
      no dental treatment in the previous 30 days, capable of normal toothbrushing, and no Sjogrens
      disease, immunodeficiency, pregnancy, poorly-controlled diabetes, or regular systemic
      antibiotics, anti-inflammatory drugs or immune suppressants. Ten patients in each tooth gel
      group will be instructed to apply a pea size amount of dentifrice brushing the implant and
      mucosa 2 times daily for 30 days. Baseline and 30-day examinations will be conducted to
      record Gingivitis Index, Plaque Index, probing depths, clinical photo, crevicular fluid, and
      adverse events.
This will be a prospective, randomized, controlled, double-blind, single center study. Once
      eligibility has been determined, up to 21 Subjects will be enrolled. Subjects will be
      randomly assigned in a 1:1 ratio to treat with either Livionex Dental Gel (a plaque control
      gel that is safe for ingestion and is currently sold by Livionex Inc.) or the control
      Aquafresh toothpaste. Each study visit will last 30 minutes.

      The soft tissue around the dental implant will be observed at baseline and after 30 days for
      inflammation using the Gingivitis Index and probed with a UNC 15 periodontol probe for pocket
      depth and bleeding. A photograph will be taken of the most inflamed side of the implant.
      Plaque will be stained with oral hygiene staining rinse and evaluated for Plaque Index.
      Finally, a paper strip will be inserted between the gingiva and implant on facial and lingual
      sides for 30 seconds each.

      GINGIVITIS INDEX: Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation, 1 =
      Mild inflammation slight change in color and little change in texture 2 = Moderate
      inflammation moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon
      probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous
      bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around
      the tooth) scored.

      PLAQUE INDEX Using Quigley Staining Hein Method with Turesky Modification:Units on a scale 0
      to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band
      of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two
      thirds of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque
      score = sum of all scores divided by the number of sites (teeth) scored.

      Each patients will be instructed to brush around the implant with a pea size amount of
      dentifrice provided, twice daily for 30 days.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized, controlled, double-blind, single center
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Gels are in coded opaque tubes created at the manufacturer
measure: Gingival Index
time frame: 30 days
description: Level of clinical inflammation around dental implant
measure: Plaque Index
time frame: 30 days
description: Amount of biofilm around dental implant
measure: Crevicular Fluid Biomarkers
time frame: 30 days
description: Fluid from around implant measured for inflammation markers with ELISA
arm group label: Livionex gel
arm group type: Active Comparator
description: Brushing area of mucositis with Livionex gel for 30 days
arm group label: Aquafresh gel
arm group type: Active Comparator
description: Brushing area of mucositis with Aquafresh gel for 30 days
intervention type: Other
intervention name: Livionex gel
description: Brushing area of mucositis with gel
arm group label: Livionex gel
other name: Aquafresh gel
intervention type: Other
intervention name: Aquafresh gel
description: Aquafresh gel
arm group label: Aquafresh gel
criteria: 
gender: All
minimum age: 19 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: Richard Reinhardt
investigator title: Professor
mesh term: Mucositis
sharing ipd: No