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NCT Number: NCT02764060

The Effect of Tongue Cleaning in 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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tongue Coating

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UZLeuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tongue scraper

Device

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))

Toothbrush

Device

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)

Primary outcomes

  1. Extension of the tongue coating

    Time frame: 14 days

    Extension of the tongue coating measured according to Miyazaki (1995) and Winkel (2003).

Secondary outcomes

  1. Bacterial load measured by culturing methods

    Time frame: 14 days

    Microbiological composition of the tongue coating.

  2. Bacterial load measured by means of qPCR

    Time frame: 14 days

    Microbiological composition of the tongue coating.

  3. Bacterial composition of unstimulated saliva (measured with the aid of culturing methods)

    Time frame: 14 days

    Microbiological composition of the saliva.

  4. Bacterial composition of unstimulated saliva (measured with qPCR)

    Time frame: 14 days

    Microbiological composition of the saliva.

  5. 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 6, 2016
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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