The Effect of Tongue Cleaning in Periodontitis Patients

May 3, 2016 updated by: Universitaire Ziekenhuizen KU Leuven

The Effect of Tongue Scraping Compared to Tongue Cleaning on the Tongue Coating of Periodontitis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tongue scraper
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.
Device: Tongue scraper
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.
Other Names:
  • Tongue scraper (Halita® tongue cleaner (Dentaid, Spain))
Experimental: Toothbrush
In this group the subjects are explained how to use a toothbrush (Oral-B® Indicator® medium tooth brush) to clean their tongues.
Device: Toothbrush
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.
Other Names:
  • Toothbrush (Oral-B® Indicator® medium tooth brush)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extension of the tongue coating
Time Frame: 14 days
Extension of the tongue coating measured according to Miyazaki (1995) and Winkel (2003).
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial load measured by culturing methods
Time Frame: 14 days
Microbiological composition of the tongue coating.
14 days
Bacterial load measured by means of qPCR
Time Frame: 14 days
Microbiological composition of the tongue coating.
14 days
Bacterial composition of unstimulated saliva (measured with the aid of culturing methods)
Time Frame: 14 days
Microbiological composition of the saliva.
14 days
Bacterial composition of unstimulated saliva (measured with qPCR)
Time Frame: 14 days
Microbiological composition of the saliva.
14 days
Experience of the subject of tongue coating related factors measured using a questionnaire
Time Frame: 14 days
Experience of the subject of the breath odour, taste perception; and cleanliness of the tongue.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Study Director: Marc Quirynen, marc.quirynen@uzleuven.be

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 3, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s54161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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