|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 May 2016 |
|
Main ID: |
NCT02764060 |
|
Date of registration:
|
27/04/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Effect of Tongue Cleaning in Periodontitis Patients
|
|
Scientific title:
|
The Effect of Tongue Scraping Compared to Tongue Cleaning on the Tongue Coating of Periodontitis Patients |
|
Date of first enrolment:
|
January 2011 |
|
Target sample size:
|
18 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02764060 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 0
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
Marc Quirynen |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
marc.quirynen@uzleuven.be |
| | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Periodontitis
|
|
Tongue Coating
|
|
Intervention(s)
|
|
Device: Tongue scraper
|
|
Device: Toothbrush
|
|
Primary Outcome(s)
|
|
Extension of the tongue coating
[Time Frame: 14 days]
|
|
Secondary Outcome(s)
|
|
Bacterial composition of unstimulated saliva (measured with the aid of culturing methods)
[Time Frame: 14 days]
|
|
Bacterial load measured by culturing methods
[Time Frame: 14 days]
|
|
Experience of the subject of tongue coating related factors measured using a questionnaire
[Time Frame: 14 days]
|
|
Bacterial load measured by means of qPCR
[Time Frame: 14 days]
|
|
Bacterial composition of unstimulated saliva (measured with qPCR)
[Time Frame: 14 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|