Effectiveness of Different Candies Against Bad Breath (HALIDROP)

June 1, 2021 updated by: University Hospital, Basel, Switzerland
This study is to analyze whether the candies can relieve or eliminate bad breath, both subjectively and objectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4058
        • Universitäres Zentrum für Zahnmedizin UZB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: candy intake
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
max 60 minutes at 3 different days
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)
max 60 minutes at 3 different days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Ricola Group AG Schweiz

Investigators

  • Principal Investigator: Andreas Filippi, Prof. Dr. med. dent., Universitäres Zentrum für Zahnmedizin Basel (UZB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01943; ex20Filippi

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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