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Withdrawn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
About this trial
This is an interventional treatment trial for Halitosis focused on measuring halitosis, periodontal debridement, chemotherapeutics
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
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
NCT ID
NCT02665780
First Posted
January 25, 2016
Last Updated
October 10, 2018
Sponsor
University of British Columbia
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Withdrawn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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