Bad BreathHALIDROPNCT04589481
Effectiveness of Different Candies Against Bad Breath
A study testing Intake of 3 different candies against bad breath in people with Bad Breath, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to analyze whether the candies can relieve or eliminate bad breath, both subjectively and objectively. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bad Breath
- What is being tested?
- Intake of 3 different candies against bad breath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Feb 2021to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non- smoker
- No general medical illness or medication
Who cannot join
- Allergies/intolerances to ingredients of the products used
- Chronic diseases
- Smoker
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
This study is to analyze whether the candies can relieve or eliminate bad breath, both subjectively and objectively.
Read the 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.
- Conditions
- Bad Breath
- Being tested
- Intake of 3 different candies against bad breath
- Keywords
- halitosis, volatile sulphur compounds
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intake of 3 different candies against bad breathOther
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
| Study group | Role | What they receive |
|---|---|---|
| candy intake | Experimental | Not described Receives: Other: Intake of 3 different candies against bad breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: max 60 minutes at 3 different days
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)
Measured: max 60 minutes at 3 different days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start23 Feb 2021
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bad BreathStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Ricola Group AG Schweiz
- Responsible party
- Sponsor
- Investigators
- Andreas Filippi, Prof. Dr. med. dent., Principal investigator, Universitäres Zentrum für Zahnmedizin Basel (UZB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589481
- Sponsor's protocol ID
- 2020-01943; ex20Filippi
- Acronym
- HALIDROP
- Status last verified
- Jun 2021
- First submitted
- 14 Oct 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Candies Against Bad Breath
- ClinicalTrials.gov ID
- NCT04589481
- Acronym / sponsor ID
- HALIDROP / 2020-01943; ex20Filippi
- Conditions
- Bad Breath
- Keywords
- halitosis, volatile sulphur compounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Ricola Group AG Schweiz
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| candy intake | Experimental | Other: Intake of 3 different candies against bad breath |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non- smoker
- No general medical illness or medication
Key exclusion criteria (4 listed)
- Allergies/intolerances to ingredients of the products used
- Chronic diseases
- Smoker
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intake of 3 different candies against bad breathIntake 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 | Other | candy intake |
Primary outcome
Organoleptic analysis of breathing air sample
Time frame: max 60 minutes at 3 different days
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).
Time frame: max 60 minutes at 3 different days
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Filippi, Prof. Dr. med. dent. principal investigator
Universitäres Zentrum für Zahnmedizin Basel (UZB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intake of 3 different candies against bad breath in people with Bad Breath, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organoleptic analysis of breathing air sample (time frame: max 60 minutes at 3 different days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.