<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/NCT02221193</url>
  </required_header>
  <id_info>
    <org_study_id>0568677142</org_study_id>
    <nct_id>NCT02221193</nct_id>
  </id_info>
  <brief_title>Comparing Site Specific Mouth Disinfection With Commercial Oral Mouth Rinse With Traditional Oral Maouth Disinfection</brief_title>
  <official_title>Site-Specific Mouth Rinsing to Improve Oral Odor by Altering Bacterial Counts: Blind Crossover Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Baha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Baha University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: To determine whether site-specific mouth rinsing with oral disinfectants can&#xD;
      improve oral odor beyond the traditional panoral mouth disinfection with mouth rinses by&#xD;
      targeting specifically oral malodor implicate anaerobic bacteria.&#xD;
&#xD;
      Methods: Twenty healthy fasting subjects volunteered for a blinded prospective, descriptive&#xD;
      correlational crossover cross-section clinical trial conduct during the month of Ramadan in&#xD;
      the lunar Hajri year 1434 AH (10 July 2013-8 August 2013) in Albaha province in Saudi Arabia&#xD;
      involving the application of Listerine® Cool Mint® mouth rinse by either the traditional&#xD;
      panoral rinsing method or a site-specific disinfection method targeting the subgingival and&#xD;
      supragingival plaque and the posterior third of the tongue dorsum while avoiding the&#xD;
      remaining locations within the oral cavity. The viable anaerobic and aerobic bacterial&#xD;
      counts, volatile sulfur compounds (VSCs) levels, organoleptic assessment of oral odor and the&#xD;
      tongue-coating index were compared at baseline, 1, 5 and 9 hours after the treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>viable anaerobic and aerobic bacterial counts</measure>
    <time_frame>one month</time_frame>
    <description>Measuring bacterial numbers by culturing of saliva samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>assessment of oral odor</measure>
    <time_frame>one month</time_frame>
    <description>the mouth odor was assisted by smelling</description>
  </primary_outcome>
  <primary_outcome>
    <measure>volatile sulfur compounds (VSCs) levels</measure>
    <time_frame>one month</time_frame>
    <description>these compound measured in part per million</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Oral Odor (Halitosis)</condition>
  <condition>The Study Want to Know if Site Specific Mouth Rinsing With Oral Mouth Disinfectants Can be Better Than Paonoral Mouth Rinsing</condition>
  <arm_group>
    <arm_group_label>site specific vs panoral disinfection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>traditional mouth rinsing and site-specific mouth rinsing (crossover)</intervention_name>
    <description>blinded prospective, descriptive correlational crossover cross-section clinical trial conduct during the month of Ramadan in the lunar Hajri year 1434 AH (10 July 2013-8 August 2013) in Albaha province in Saudi Arabia involving the application of Listerine® Cool Mint® mouth rinse by either the traditional panoral rinsing method or a site-specific disinfection method targeting the subgingival and supragingival plaque and the posterior third of the tongue dorsum while avoiding the remaining locations within the oral cavity</description>
    <arm_group_label>site specific vs panoral disinfection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Saudi Arabia volunteers to be recruited from Albaha province of Saudi Arabia via an&#xD;
             online invitation on the e-learning blog www.alqumber.wordpress.com&#xD;
&#xD;
          2. No antibiotic usage and no antiseptic mouth rinse use for the last 3 months and one&#xD;
             week preceding the commencement of the study, respectively.&#xD;
&#xD;
          3. Must be dentate healthy Saudi males aged 17-65 years, who adhere to the ritual of&#xD;
             fasting.&#xD;
&#xD;
          4. provided informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Receiving any professional periodontal treatments (prophylactic scaling, root planning,&#xD;
        and periodontal surgery) or professional advice during the previous year. 2. Prior to the&#xD;
        inception of the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 19, 2014</last_update_submitted>
  <last_update_submitted_qc>August 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Baha University</investigator_affiliation>
    <investigator_full_name>Dr Mohammed Abdullah Alqumber</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Halitosis</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/NCT02221193
org study id: 0568677142
nct id: NCT02221193
lead sponsor: 
has dmc: No
Objectives: To determine whether site-specific mouth rinsing with oral disinfectants can
      improve oral odor beyond the traditional panoral mouth disinfection with mouth rinses by
      targeting specifically oral malodor implicate anaerobic bacteria.

      Methods: Twenty healthy fasting subjects volunteered for a blinded prospective, descriptive
      correlational crossover cross-section clinical trial conduct during the month of Ramadan in
      the lunar Hajri year 1434 AH (10 July 2013-8 August 2013) in Albaha province in Saudi Arabia
      involving the application of Listerine® Cool Mint® mouth rinse by either the traditional
      panoral rinsing method or a site-specific disinfection method targeting the subgingival and
      supragingival plaque and the posterior third of the tongue dorsum while avoiding the
      remaining locations within the oral cavity. The viable anaerobic and aerobic bacterial
      counts, volatile sulfur compounds (VSCs) levels, organoleptic assessment of oral odor and the
      tongue-coating index were compared at baseline, 1, 5 and 9 hours after the treatment.
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: viable anaerobic and aerobic bacterial counts
time frame: one month
description: Measuring bacterial numbers by culturing of saliva samples
measure: assessment of oral odor
time frame: one month
description: the mouth odor was assisted by smelling
measure: volatile sulfur compounds (VSCs) levels
time frame: one month
description: these compound measured in part per million
arm group label: site specific vs panoral disinfection
arm group type: Experimental
intervention type: Other
intervention name: traditional mouth rinsing and site-specific mouth rinsing (crossover)
description: blinded prospective, descriptive correlational crossover cross-section clinical trial conduct during the month of Ramadan in the lunar Hajri year 1434 AH (10 July 2013-8 August 2013) in Albaha province in Saudi Arabia involving the application of Listerine® Cool Mint® mouth rinse by either the traditional panoral rinsing method or a site-specific disinfection method targeting the subgingival and supragingival plaque and the posterior third of the tongue dorsum while avoiding the remaining locations within the oral cavity
arm group label: site specific vs panoral disinfection
criteria: 
gender: Male
minimum age: 17 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Al-Baha University
investigator full name: Dr Mohammed Abdullah Alqumber
investigator title: Assistant Professor
mesh term: Halitosis