<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/NCT02203812</url>
  </required_header>
  <id_info>
    <org_study_id>VIJ_GIN-PRO 01</org_study_id>
    <nct_id>NCT02203812</nct_id>
  </id_info>
  <brief_title>Effect of Probiotic Lozenge on Gingivitis and Periodontitis</brief_title>
  <official_title>The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild &amp; Moderate Periodontitis: A Randomized Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CD Pharma India Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Government Dental College and Hospital, Vijayawada, Andra Pradesh, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CD Pharma India Pvt. Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The oral cavity is mostly influenced by general health. The oral microbiota which is as&#xD;
      complex as the gastro-intestinal or vaginal microbiota are considered to be difficult&#xD;
      therapeutic targets. The effects of probiotics in different fields of health care have&#xD;
      resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been&#xD;
      clinically proved effective in different fields of oral healthcare such as halitosis, oral&#xD;
      candidiasis and tooth decay. They have also been inducted in the field of periodontal&#xD;
      healthcare because of the current views on the etiology of plaque- related periodontal&#xD;
      inflammation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Clinical Periodontal Indices</measure>
    <time_frame>8 weeks</time_frame>
    <description>Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in Biochemical Indices</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Mild and Moderate Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Probiotic Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>L. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Probiotic Arm</intervention_name>
    <description>Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2</description>
    <arm_group_label>Probiotic Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Arm</intervention_name>
    <description>Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)</description>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Patients with chronic mild to moderate periodontitis.&#xD;
&#xD;
          -  Having Pocket depth &gt; 4mm.&#xD;
&#xD;
          -  Mean loss of attachment, evaluated by measuring the distance from cement-enamel&#xD;
             junction to the bottom of the probing pocket &gt; 4mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on probiotic supplements&#xD;
&#xD;
          -  Patients who have allergy to lactose and fermented milk products&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6&#xD;
             months&#xD;
&#xD;
          -  Patients with advanced periodontal and/or periapical conditions which necessitate&#xD;
             immediate treatment&#xD;
&#xD;
          -  Patient suffering from any systemic illness&#xD;
&#xD;
          -  Patients who are deemed to be un-cooperative&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Surya Jyotsna Kiran Kanchumurthy, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Government Dental College and Hospital, Vijayawada, Andhra Pradesh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Narendra Dev Jampani, MDS</last_name>
    <role>Study Director</role>
    <affiliation>Government Dental College and Hospital, Vijayawada, Andhra Pradesh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vajra Madhuri S, MDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Government Dental College and Hospital, Vijayawada, Andhra Pradesh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Periodontology, Government Dental College &amp; Hospital</name>
      <address>
        <city>Vijayawada</city>
        <state>Andra Pradesh</state>
        <zip>520004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 26, 2016</last_update_submitted>
  <last_update_submitted_qc>July 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 27, 2016</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>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</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/NCT02203812
org study id: VIJ_GIN-PRO 01
nct id: NCT02203812
lead sponsor: 
collaborator: 
has dmc: No
The oral cavity is mostly influenced by general health. The oral microbiota which is as
      complex as the gastro-intestinal or vaginal microbiota are considered to be difficult
      therapeutic targets. The effects of probiotics in different fields of health care have
      resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been
      clinically proved effective in different fields of oral healthcare such as halitosis, oral
      candidiasis and tooth decay. They have also been inducted in the field of periodontal
      healthcare because of the current views on the etiology of plaque- related periodontal
      inflammation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Improvement in Clinical Periodontal Indices
time frame: 8 weeks
description: Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP)
measure: Improvement in Biochemical Indices
time frame: 8 weeks
description: Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF)
arm group label: Probiotic Arm
arm group type: Experimental
description: L. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2.
arm group label: Placebo Arm
arm group type: Placebo Comparator
description: Placebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2).
intervention type: Drug
intervention name: Probiotic Arm
description: Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2
arm group label: Probiotic Arm
intervention type: Drug
intervention name: Placebo Arm
description: Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)
arm group label: Placebo Arm
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Surya Jyotsna Kiran Kanchumurthy, BDS
role: Principal Investigator
affiliation: Government Dental College and Hospital, Vijayawada, Andhra Pradesh
last name: Narendra Dev Jampani, MDS
role: Study Director
affiliation: Government Dental College and Hospital, Vijayawada, Andhra Pradesh
last name: Vajra Madhuri S, MDS
role: Principal Investigator
affiliation: Government Dental College and Hospital, Vijayawada, Andhra Pradesh
facility: 
country: India
responsible party type: Sponsor
mesh term: Gingivitis
mesh term: Periodontitis
mesh term: Chronic Periodontitis