The Effect of Tongue Cleaning in Periodontitis Patients

Early Phase 1

Completed

• Conditions: Tongue Coating; Periodontitis
• Interventions: Device: Toothbrush; Device: Tongue scraper

• Registration Number: NCT02764060
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-03
• Last Update Submitted: 2016-05-03
• Study First Posted: 2016-05-06
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toothbrush	Toothbrush	In this group the subjects are explained how to use a toothbrush (Oral-B® Indicator® medium tooth brush) to clean their tongues.
Tongue scraper	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.

Primary Outcome Measures

Name	Time	Method
Extension of the tongue coating	14 days	Extension of the tongue coating measured according to Miyazaki (1995) and Winkel (2003).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium