NCT02764060

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2011

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
Last Updated

May 6, 2016

Status Verified

April 1, 2016

Enrollment Period

4 years

First QC Date

April 27, 2016

Last Update Submit

May 3, 2016

Conditions

Keywords

PeriodontitisTongue coatingTongue cleaningBacterial load

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

EXPERIMENTAL

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

Toothbrush

EXPERIMENTAL

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

Device: Toothbrush

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.

Also known as: Tongue scraper (Halita® tongue cleaner (Dentaid, Spain))
Tongue scraper

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.

Also known as: Toothbrush (Oral-B® Indicator® medium tooth brush)
Toothbrush

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Marc Quirynen

    marc.quirynen@uzleuven.be

    STUDY DIRECTOR

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

Locations