Effectiveness of Different Candies Against Bad Breath (HALIDROP)
Primary Purpose
Bad Breath
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Intake of 3 different candies against bad breath
Sponsored by
About this trial
This is an interventional diagnostic trial for Bad Breath focused on measuring halitosis, volatile sulphur compounds
Eligibility Criteria
Inclusion Criteria:
- Non- smoker
- No general medical illness or medication
Exclusion Criteria:
- Allergies/intolerances to ingredients of the products used
- Chronic diseases
- Smoker
- Pregnancy
Sites / Locations
- Universitäres Zentrum für Zahnmedizin UZB
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
candy intake
Arm Description
Outcomes
Primary Outcome Measures
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))
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04589481
First Posted
October 14, 2020
Last Updated
June 1, 2021
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Ricola Group AG Schweiz
1. Study Identification
Unique Protocol Identification Number
NCT04589481
Brief Title
Effectiveness of Different Candies Against Bad Breath
Acronym
HALIDROP
Official Title
Effectiveness of Different Candies Against Bad Breath
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Ricola Group AG Schweiz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to analyze whether the candies can relieve or eliminate bad breath, both subjectively and objectively.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bad Breath
Keywords
halitosis, volatile sulphur compounds
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Three different variants of a candy are being tested by each participant. The candies are randomly assigned to the subjects, so that each subject has tested each of the three candies once. Randomization creates a different order for each participant. The study will be carried out on three different days.
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
candy intake
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Intake of 3 different candies against bad breath
Intervention Description
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
Primary Outcome Measure Information:
Title
Organoleptic analysis of breathing air sample
Description
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))
Time Frame
max 60 minutes at 3 different days
Title
Measurement of volatile sulphur compounds (VSC) in ppb (parts per billion).
Description
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)
Time Frame
max 60 minutes at 3 different days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Non- smoker
No general medical illness or medication
Exclusion Criteria:
Allergies/intolerances to ingredients of the products used
Chronic diseases
Smoker
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Filippi, Prof. Dr. med. dent.
Organizational Affiliation
Universitäres Zentrum für Zahnmedizin Basel (UZB)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäres Zentrum für Zahnmedizin UZB
City
Basel
ZIP/Postal Code
4058
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Different Candies Against Bad Breath
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