The Effect of Tongue Cleaning in Periodontitis Patients
Primary Purpose
Periodontitis, Tongue Coating
Status
Completed
Phase
Early Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Tongue scraper
Toothbrush
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Tongue coating, Tongue cleaning, Bacterial load
Eligibility Criteria
Inclusion Criteria:
- systemically healthy patients
- periodontitis patients
Exclusion Criteria:
- already using a tongue cleaning device
- use of antibiotics the previous 6 months
- rinsing with a chlorhexidine mouth rinse the past month
- smokers
- patients who underwent periodontal therapy the past three years were not included.
Sites / Locations
- UZLeuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tongue scraper
Toothbrush
Arm Description
In this group the subjects are explained how to use a plastic loop-formed tongue cleaner (Halita® tongue cleaner (Dentaid, Spain)) to clean their tongues.
In this group the subjects are explained how to use a toothbrush (Oral-B® Indicator® medium tooth brush) to clean their tongues.
Outcomes
Primary Outcome Measures
Extension of the tongue coating
Extension of the tongue coating measured according to Miyazaki (1995) and Winkel (2003).
Secondary Outcome Measures
Bacterial load measured by culturing methods
Microbiological composition of the tongue coating.
Bacterial load measured by means of qPCR
Microbiological composition of the tongue coating.
Bacterial composition of unstimulated saliva (measured with the aid of culturing methods)
Microbiological composition of the saliva.
Bacterial composition of unstimulated saliva (measured with qPCR)
Microbiological composition of the saliva.
Experience of the subject of tongue coating related factors measured using a questionnaire
Experience of the subject of the breath odour, taste perception; and cleanliness of the tongue.
Full Information
NCT ID
NCT02764060
First Posted
April 27, 2016
Last Updated
May 3, 2016
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT02764060
Brief Title
The Effect of Tongue Cleaning in Periodontitis Patients
Official Title
The Effect of Tongue Scraping Compared to Tongue Cleaning on the Tongue Coating of Periodontitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to examine in periodontitis patients with visible tongue coating the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper versus the use of a regular toothbrush to clean the tongue.
Detailed Description
Volatile sulphur compounds (VSC's) are the most important causes of bad breath. Since the micro-organisms that produce VSC's are also periodopathogens, intuitively, one would think that there is a positive correlation between VSC levels in exhaled breath and periodontitis. However, not all periodontitis patients have bad breath. A possible explanation can be a positive relationship between tongue coating an bad breath. In the past, tongue cleaning was already researched in an oral healthy population. This research aimed to examine in periodontitis patients with visible tongue coating the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper versus the use of a regular toothbrush to clean the tongue. Additionally changes in tongue coating; and patient perception about tongue cleaning was researched.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Tongue Coating
Keywords
Periodontitis, Tongue coating, Tongue cleaning, Bacterial load
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tongue scraper
Arm Type
Experimental
Arm Description
In this group the subjects are explained how to use a plastic loop-formed tongue cleaner (Halita® tongue cleaner (Dentaid, Spain)) to clean their tongues.
Arm Title
Toothbrush
Arm Type
Experimental
Arm Description
In this group the subjects are explained how to use a toothbrush (Oral-B® Indicator® medium tooth brush) to clean their tongues.
Intervention Type
Device
Intervention Name(s)
Tongue scraper
Other Intervention Name(s)
Tongue scraper (Halita® tongue cleaner (Dentaid, Spain))
Intervention Description
The patients were instructed to start cleaning the tongue by two pulling strokes along the median sulcus of the tongue, followed by two pulling strokes along the lateral edges of the tongue.
Intervention Type
Device
Intervention Name(s)
Toothbrush
Other Intervention Name(s)
Toothbrush (Oral-B® Indicator® medium tooth brush)
Intervention Description
The patients who were assigned to the tooth brush group were taught to perform three forward and backward strokes along the median sulcus and at each lateral part of the tongue.
Primary Outcome Measure Information:
Title
Extension of the tongue coating
Description
Extension of the tongue coating measured according to Miyazaki (1995) and Winkel (2003).
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Bacterial load measured by culturing methods
Description
Microbiological composition of the tongue coating.
Time Frame
14 days
Title
Bacterial load measured by means of qPCR
Description
Microbiological composition of the tongue coating.
Time Frame
14 days
Title
Bacterial composition of unstimulated saliva (measured with the aid of culturing methods)
Description
Microbiological composition of the saliva.
Time Frame
14 days
Title
Bacterial composition of unstimulated saliva (measured with qPCR)
Description
Microbiological composition of the saliva.
Time Frame
14 days
Title
Experience of the subject of tongue coating related factors measured using a questionnaire
Description
Experience of the subject of the breath odour, taste perception; and cleanliness of the tongue.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
systemically healthy patients
periodontitis patients
Exclusion Criteria:
already using a tongue cleaning device
use of antibiotics the previous 6 months
rinsing with a chlorhexidine mouth rinse the past month
smokers
patients who underwent periodontal therapy the past three years were not included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Quirynen
Organizational Affiliation
marc.quirynen@uzleuven.be
Official's Role
Study Director
Facility Information:
Facility Name
UZLeuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15191584
Citation
Quirynen M, Avontroodt P, Soers C, Zhao H, Pauwels M, van Steenberghe D. Impact of tongue cleansers on microbial load and taste. J Clin Periodontol. 2004 Jul;31(7):506-10. doi: 10.1111/j.0303-6979.2004.00507.x.
Results Reference
background
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The Effect of Tongue Cleaning in Periodontitis Patients
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