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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04589481
Other study ID # 2020-01943; ex20Filippi
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 23, 2021
Est. completion date June 1, 2021

Study information

Verified date June 2021
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to analyze whether the candies can relieve or eliminate bad breath, both subjectively and objectively.


Description:

This study is to systematically examine an existing candy, which is easily available and is intended to relieve or eliminate bad breath. The main aim of the study is to determine the effectiveness of the candies on the subjective perception of bad breath. The secondary outcome of the study is to investigate whether there is actually a decrease in volatile sulphur compounds (VSC) in the exhaled air and also a decrease in bad breath during organoleptic measurement. The purpose of the study is to investigate whether the different candies can relieve or eliminate bad breath, both subjectively and objectively.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Non- smoker - No general medical illness or medication Exclusion Criteria: - Allergies/intolerances to ingredients of the products used - Chronic diseases - Smoker - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intake of 3 different candies against bad breath
Intake of 3 different candies against bad breath on three different days (2-days interval each) after artificially creating a temporary bad breath (by eating of chips and cheese); analysis of breathing during intake of candy both subjectively and objectively

Locations

Country Name City State
Switzerland Universitäres Zentrum für Zahnmedizin UZB Basel

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Ricola Group AG Schweiz

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Organoleptic analysis of breathing air sample Assessment of the patient's bad breath on the basis of the subjective assessment of an investigator (scale of 0 to 5 (0, no odor; 1, questionable odor; 2, slight malodor; 3, moderate malodor; 4, strong malodor; 5, severe malodor)) max 60 minutes at 3 different days
Primary Measurement of volatile sulphur compounds (VSC) in ppb (parts per billion). Assessment of the patient's bad breath on the basis of the objective assessment by a sulfide monitor (HaliSens® AI Analytical Innovations GmbH, Moosbach, Germany) max 60 minutes at 3 different days
See also
  Status Clinical Trial Phase
Completed NCT00250289 - Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula Phase 1
Completed NCT03053882 - Efficacy of Peppermint and Green Tea in Malodor N/A