Effectiveness of Different Candies Against Bad Breath

NCT04589481 | Completed

• 1 other identifier: 2020-01943; ex20Filippi
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bad Breath

Keywords

halitosis; volatile sulphur compounds

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

candy intake

EXPERIMENTAL

Other: Intake of 3 different candies against bad breath

Interventions

Intake of 3 different candies against bad breath OTHER

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

candy intake

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non- smoker
• No general medical illness or medication

You may not qualify if:

• Allergies/intolerances to ingredients of the products used
• Chronic diseases
• Smoker
• Pregnancy

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Ricola Group AG Schweiz: collaborator

Study Sites (1)

Universitäres Zentrum für Zahnmedizin UZB

Basel, 4058, Switzerland

Location

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Filippi, Prof. Dr. med. dent.

  Universitäres Zentrum für Zahnmedizin Basel (UZB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 19, 2020
• Study Start: February 23, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-06

Locations

CH (1)