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Assessing the Effect of Periodontal Debridement, Tongue Cleaning and Mouth Rinsing for the Treatment of Oral Malodour

Primary Purpose

Halitosis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Periodontal debridement
Cetylpyridium chloride
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis focused on measuring halitosis, periodontal debridement, chemotherapeutics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Organoleptic score of 2 or more, and volatile sulfur compound score of greater than 1.5ng/10ml of hydrogen sulfide and 0.5ng/10ml of methyl mercaptan

-

Exclusion Criteria:

  • Moderate to severe periodontal disease, systemic illness or dental disease associated with halitosis, antibiotic use in the past month, need for antibiotic prophylaxis for dental procedures and current smokers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Periodontal debridement, tongue cleaning, mouth rinsing with 20ml Cetylpyridium Chloride daily for 24 weeks

    Outcomes

    Primary Outcome Measures

    Reduction of oral malodour below threshold

    Secondary Outcome Measures

    Full Information

    First Posted
    January 25, 2016
    Last Updated
    October 10, 2018
    Sponsor
    University of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02665780
    Brief Title
    Assessing the Effect of Periodontal Debridement, Tongue Cleaning and Mouth Rinsing for the Treatment of Oral Malodour
    Official Title
    Assessing the Effect of Periodontal Debridement, Tongue Cleaning and Mouth Rinsing for the Treatment of Oral Malodour
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    funding was not secured
    Study Start Date
    October 2017 (Anticipated)
    Primary Completion Date
    October 10, 2018 (Actual)
    Study Completion Date
    October 10, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of British Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the short and long term effect of dental cleaning and mouthrinsing for the treatment of bad breath
    Detailed Description
    The majority of bad breath producing bacteria can be found in pockets around the gums and the top of the tongue. It is generally agreed that one of the most effective means of controlling the production of bad breath gases from these bacteria is their mechanical removal. Tongue cleaning has shown consistent results in the reduction of bad breath, while dental cleaning has shown positive, but less conclusive results. The addition of a mouth rinse to mechanical measures has shown medium-term effectiveness, however there is currently no information available that describes the long-term impact of mechanical and chemical measures for the treatment of bad breath and the appropriate interval for follow-up and on-going management to prevent difficult cases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Halitosis
    Keywords
    halitosis, periodontal debridement, chemotherapeutics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Periodontal debridement, tongue cleaning, mouth rinsing with 20ml Cetylpyridium Chloride daily for 24 weeks
    Intervention Type
    Procedure
    Intervention Name(s)
    Periodontal debridement
    Intervention Description
    teeth cleaning
    Intervention Type
    Other
    Intervention Name(s)
    Cetylpyridium chloride
    Intervention Description
    mouthrinse
    Primary Outcome Measure Information:
    Title
    Reduction of oral malodour below threshold
    Time Frame
    1, 12, 24 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Organoleptic score of 2 or more, and volatile sulfur compound score of greater than 1.5ng/10ml of hydrogen sulfide and 0.5ng/10ml of methyl mercaptan - Exclusion Criteria: Moderate to severe periodontal disease, systemic illness or dental disease associated with halitosis, antibiotic use in the past month, need for antibiotic prophylaxis for dental procedures and current smokers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leeann Donnelly, PhD
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Assessing the Effect of Periodontal Debridement, Tongue Cleaning and Mouth Rinsing for the Treatment of Oral Malodour

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