The Effect of Tongue Cleaning in Periodontitis Patients
The Effect of Tongue Scraping Compared to Tongue Cleaning on the Tongue Coating of Periodontitis Patients
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Jan 2011
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 27, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedMay 6, 2016
April 1, 2016
4 years
April 27, 2016
May 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Extension of the tongue coating
Extension of the tongue coating measured according to Miyazaki (1995) and Winkel (2003).
14 days
Secondary Outcomes (5)
Bacterial load measured by culturing methods
14 days
Bacterial load measured by means of qPCR
14 days
Bacterial composition of unstimulated saliva (measured with the aid of culturing methods)
14 days
Bacterial composition of unstimulated saliva (measured with qPCR)
14 days
Experience of the subject of tongue coating related factors measured using a questionnaire
14 days
Study Arms (2)
Tongue scraper
EXPERIMENTALIn this group the subjects are explained how to use a plastic loop-formed tongue cleaner (Halita® tongue cleaner (Dentaid, Spain)) to clean their tongues.
Toothbrush
EXPERIMENTALIn this group the subjects are explained how to use a toothbrush (Oral-B® Indicator® medium tooth brush) to clean their tongues.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- systemically healthy patients
- periodontitis patients
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZLeuven
Leuven, 3000, Belgium
Related Publications (1)
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.
PMID: 15191584BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marc Quirynen
marc.quirynen@uzleuven.be
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2016
First Posted
May 6, 2016
Study Start
January 1, 2011
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
May 6, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share