<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/NCT03004196</url>
  </required_header>
  <id_info>
    <org_study_id>CD-01</org_study_id>
    <nct_id>NCT03004196</nct_id>
  </id_info>
  <brief_title>Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans</brief_title>
  <official_title>Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peoples University, Bhanpur, Bhopal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peoples University, Bhanpur, Bhopal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Orthodontic appliance causes increase in plaque accumulation, especially around brackets,&#xD;
      wires and attachments. Advances in orthodontics in recent time have led to improved quality&#xD;
      of appliance and treatment procedures ultimately resulting in improvised standard of patient&#xD;
      care.&#xD;
&#xD;
      These bacteria metabolize different kind of carbohydrates accumulated around orthodontic&#xD;
      appliances and create acidic environment in the oral cavity leading to enamel&#xD;
      demineralization around the brackets and white spot lesions.&#xD;
&#xD;
      This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and&#xD;
      chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are&#xD;
      not using them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION - When the basic oral hygiene is poor, orthodontic appliances create areas where&#xD;
      plaque gets accumulated, especially around brackets, bands, wires, and other attachments;&#xD;
      this facilitates the development of white spot lesions. Probiotics act by competitively&#xD;
      inhibiting the pathogenic bacteria because they have greater adhesion to the tissues while&#xD;
      Chlorhexidine is often used as an active ingredient in mouthwash designed to reduce dental&#xD;
      plaque around orthodontic appliances. AIM &amp; OBJECTIVE - The objectives of the study is to&#xD;
      evaluate and compare the effects of the topical application of probiotic toothpaste and&#xD;
      chlorhexidine mouthwash on the Streptococcus Mutans levels in the plaque of orthodontic&#xD;
      patients hence improving the oral micro-flora of oral cavity by competitive inhibition of&#xD;
      Streptococcus Mutans in plaque present around brackets.&#xD;
&#xD;
      MATERIAL &amp; METHOD - The study consists of thirty randomly selected orthodontic patients&#xD;
      undergoing fixed appliance treatment. The patients were divided into three groups - Control&#xD;
      Group (Group 1), Probiotic Toothpaste Group (Group 2) &amp; Chlorhexidine Mouthwash Group (Group&#xD;
      3). Samples were collected at two times interval: before the study began (Phase 1) and after&#xD;
      thirty days (Phase 2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash</measure>
    <time_frame>1 Month</time_frame>
    <description>Probiotic Toothpaste &amp; Chlorhexidine Mouthwash Reduced S.mutans when compared to Control Group</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>White Spot Lesion of Tooth</condition>
  <condition>Long Term Adverse Effects</condition>
  <condition>Caries, Dental</condition>
  <condition>Orthodontic Appliance Complication</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>They were not given probiotic toothpaste or chlorhexidine mouthwash</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were asked to brush twice daily with given &quot;G.D Probiotic Toothpaste&quot; and were asked not to eat or drink anything for half-an-hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chlorhexidine Mouthwash Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were asked to rinse daily with &quot;Dr. Reddy's Clohex&quot; chlorhexidine mouthwash of 10ml without dilution for three times a day after meals (Breakfast, Lunch Dinner) for 3-4 minutes and were asked not to eat or drink anything for half-an-hour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Probiotic Toothpaste</intervention_name>
    <description>G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria</description>
    <arm_group_label>Probiotic Group</arm_group_label>
    <other_name>G.D Probiotic Toothpaste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dr. Reddy's Clohex</intervention_name>
    <description>0.20% Chlorhexidine Mouthwash</description>
    <arm_group_label>Chlorhexidine Mouthwash Group</arm_group_label>
    <other_name>Chlorhexidine Mouthwash</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>No Probiotic toothpaste &amp; Chlorhexidine Mouthwash</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Orthodontic Treatment With The Straight Wire Appliance (MBT, 0.022-in Slot; 3M Unitek,&#xD;
             Monro- Via, Calif), Permanent Dentition (Excluding Third Molars)&#xD;
&#xD;
          -  Good General Health (No Significant Medical History Or Drug Use During The Last Month)&#xD;
&#xD;
          -  No Anti-inflammatory Or Antibiotic Medications Taken In The Month Before The Study&#xD;
&#xD;
          -  No Chewing Gum Or, Mouthwash Used In The Last Week And During The Study&#xD;
&#xD;
          -  Habit Of Brushing Twice Daily With Fluoride Toothpaste&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Patient with poor periodontal condition Patient with known medical condition e.g. Subacute&#xD;
        bacterial, endocarditis , diabetes, valvular disease ,anaemia etc&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr.Chandrika Dubey, MDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peoples University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peoples College Of Dental Science &amp; Research Center</name>
      <address>
        <city>Bhopal</city>
        <state>Madhya Pradesh</state>
        <zip>462016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Jose JE, Padmanabhan S, Chitharanjan AB. Systemic consumption of probiotic curd and use of probiotic toothpaste to reduce Streptococcus mutans in plaque around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):67-72. doi: 10.1016/j.ajodo.2013.02.023.</citation>
    <PMID>23810047</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 22, 2016</last_update_submitted>
  <last_update_submitted_qc>December 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peoples University, Bhanpur, Bhopal</investigator_affiliation>
    <investigator_full_name>Chandrika Dubey</investigator_full_name>
    <investigator_title>Post-Graduate Student</investigator_title>
  </responsible_party>
  <keyword>White Spot Lesion</keyword>
  <keyword>Probiotics</keyword>
  <keyword>Chlorhexidine</keyword>
  <keyword>Streptococcus Mutans</keyword>
  <keyword>Fixed Orthodontic Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
    <mesh_term>Long Term Adverse Effects</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 28, 2016</submitted>
    <returned>February 17, 2017</returned>
    <submitted>April 3, 2017</submitted>
    <returned>June 15, 2017</returned>
  </pending_results>
  <!-- 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/NCT03004196
org study id: CD-01
nct id: NCT03004196
lead sponsor: 
has dmc: No
Orthodontic appliance causes increase in plaque accumulation, especially around brackets,
      wires and attachments. Advances in orthodontics in recent time have led to improved quality
      of appliance and treatment procedures ultimately resulting in improvised standard of patient
      care.

      These bacteria metabolize different kind of carbohydrates accumulated around orthodontic
      appliances and create acidic environment in the oral cavity leading to enamel
      demineralization around the brackets and white spot lesions.

      This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and
      chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are
      not using them.
INTRODUCTION - When the basic oral hygiene is poor, orthodontic appliances create areas where
      plaque gets accumulated, especially around brackets, bands, wires, and other attachments;
      this facilitates the development of white spot lesions. Probiotics act by competitively
      inhibiting the pathogenic bacteria because they have greater adhesion to the tissues while
      Chlorhexidine is often used as an active ingredient in mouthwash designed to reduce dental
      plaque around orthodontic appliances. AIM & OBJECTIVE - The objectives of the study is to
      evaluate and compare the effects of the topical application of probiotic toothpaste and
      chlorhexidine mouthwash on the Streptococcus Mutans levels in the plaque of orthodontic
      patients hence improving the oral micro-flora of oral cavity by competitive inhibition of
      Streptococcus Mutans in plaque present around brackets.

      MATERIAL & METHOD - The study consists of thirty randomly selected orthodontic patients
      undergoing fixed appliance treatment. The patients were divided into three groups - Control
      Group (Group 1), Probiotic Toothpaste Group (Group 2) & Chlorhexidine Mouthwash Group (Group
      3). Samples were collected at two times interval: before the study began (Phase 1) and after
      thirty days (Phase 2).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash
time frame: 1 Month
description: Probiotic Toothpaste & Chlorhexidine Mouthwash Reduced S.mutans when compared to Control Group
arm group label: Control Group
arm group type: Active Comparator
description: They were not given probiotic toothpaste or chlorhexidine mouthwash
arm group label: Probiotic Group
arm group type: Experimental
description: Patients were asked to brush twice daily with given "G.D Probiotic Toothpaste" and were asked not to eat or drink anything for half-an-hour.
arm group label: Chlorhexidine Mouthwash Group
arm group type: Experimental
description: Patients were asked to rinse daily with "Dr. Reddy's Clohex" chlorhexidine mouthwash of 10ml without dilution for three times a day after meals (Breakfast, Lunch Dinner) for 3-4 minutes and were asked not to eat or drink anything for half-an-hour.
intervention type: Drug
intervention name: Probiotic Toothpaste
description: G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria
arm group label: Probiotic Group
other name: G.D Probiotic Toothpaste
intervention type: Drug
intervention name: Dr. Reddy's Clohex
description: 0.20% Chlorhexidine Mouthwash
arm group label: Chlorhexidine Mouthwash Group
other name: Chlorhexidine Mouthwash
intervention type: Other
intervention name: Control Group
description: No Probiotic toothpaste & Chlorhexidine Mouthwash
arm group label: Control Group
criteria: 
gender: All
minimum age: 15 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr.Chandrika Dubey, MDS
role: Principal Investigator
affiliation: Peoples University
facility: 
country: India
citation: Jose JE, Padmanabhan S, Chitharanjan AB. Systemic consumption of probiotic curd and use of probiotic toothpaste to reduce Streptococcus mutans in plaque around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):67-72. doi: 10.1016/j.ajodo.2013.02.023.
PMID: 23810047
responsible party type: Principal Investigator
investigator affiliation: Peoples University, Bhanpur, Bhopal
investigator full name: Chandrika Dubey
investigator title: Post-Graduate Student
mesh term: Dental Caries
mesh term: Long Term Adverse Effects
mesh term: Chlorhexidine
sharing ipd: Yes
submitted: December 28, 2016
returned: February 17, 2017
submitted: April 3, 2017
returned: June 15, 2017