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Comparing Site Specific Mouth Disinfection With Commercial Oral Mouth Rinse With Traditional Oral Maouth Disinfection

Primary Purpose

Oral Odor (Halitosis), The Study Want to Know if Site Specific Mouth Rinsing With Oral Mouth Disinfectants Can be Better Than Paonoral Mouth Rinsing

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
traditional mouth rinsing and site-specific mouth rinsing (crossover)
Sponsored by
Al-Baha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Odor (Halitosis)

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Saudi Arabia volunteers to be recruited from Albaha province of Saudi Arabia via an online invitation on the e-learning blog www.alqumber.wordpress.com
  2. No antibiotic usage and no antiseptic mouth rinse use for the last 3 months and one week preceding the commencement of the study, respectively.
  3. Must be dentate healthy Saudi males aged 17-65 years, who adhere to the ritual of fasting.
  4. provided informed consent form.

Exclusion Criteria:

1. Receiving any professional periodontal treatments (prophylactic scaling, root planning, and periodontal surgery) or professional advice during the previous year. 2. Prior to the inception of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    site specific vs panoral disinfection

    Arm Description

    Outcomes

    Primary Outcome Measures

    viable anaerobic and aerobic bacterial counts
    Measuring bacterial numbers by culturing of saliva samples
    assessment of oral odor
    the mouth odor was assisted by smelling
    volatile sulfur compounds (VSCs) levels
    these compound measured in part per million

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2014
    Last Updated
    August 19, 2014
    Sponsor
    Al-Baha University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02221193
    Brief Title
    Comparing Site Specific Mouth Disinfection With Commercial Oral Mouth Rinse With Traditional Oral Maouth Disinfection
    Official Title
    Site-Specific Mouth Rinsing to Improve Oral Odor by Altering Bacterial Counts: Blind Crossover Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Baha University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Odor (Halitosis), The Study Want to Know if Site Specific Mouth Rinsing With Oral Mouth Disinfectants Can be Better Than Paonoral Mouth Rinsing

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Early Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    site specific vs panoral disinfection
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    traditional mouth rinsing and site-specific mouth rinsing (crossover)
    Intervention 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
    Primary Outcome Measure Information:
    Title
    viable anaerobic and aerobic bacterial counts
    Description
    Measuring bacterial numbers by culturing of saliva samples
    Time Frame
    one month
    Title
    assessment of oral odor
    Description
    the mouth odor was assisted by smelling
    Time Frame
    one month
    Title
    volatile sulfur compounds (VSCs) levels
    Description
    these compound measured in part per million
    Time Frame
    one month

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Saudi Arabia volunteers to be recruited from Albaha province of Saudi Arabia via an online invitation on the e-learning blog www.alqumber.wordpress.com No antibiotic usage and no antiseptic mouth rinse use for the last 3 months and one week preceding the commencement of the study, respectively. Must be dentate healthy Saudi males aged 17-65 years, who adhere to the ritual of fasting. provided informed consent form. Exclusion Criteria: 1. Receiving any professional periodontal treatments (prophylactic scaling, root planning, and periodontal surgery) or professional advice during the previous year. 2. Prior to the inception of the study.

    12. IPD Sharing Statement

    Learn more about this trial

    Comparing Site Specific Mouth Disinfection With Commercial Oral Mouth Rinse With Traditional Oral Maouth Disinfection

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