Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity (DESERTO)

February 18, 2021 updated by: University Hospital, Basel, Switzerland

Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity (DESERTO)

This study is to investigate whether a candy can increase moisture of the oral cavity and reduce dryness of mouth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A candy (available on the market from a Swiss manufacturer (Ricola)), free of ingredients that could interfere with the investigation, is tested in five different versions on different days. It is to analyse whether these candies can increase moisture of the oral cavity and reduce dryness of mouth.

Study Type

Interventional

Enrollment (Actual)

33

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 Basel

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • non- smoker
  • no allergies
  • no drug- use (except for contraception)
  • healthy volunteers (no disease/infection 4 weeks before study participation)

Exclusion Criteria:

  • pregnant women

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: healthy participants starting with candy V01
healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison)
Other: V01 candy
candy with sweetener (Isomalt) and apple flavour
Other: V02 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)
Other: V03 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C
Other: V04 candy
candy with sweetener (Isomalt) (control group 1)
Other: V05 candy
candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)
Experimental: healthy participants starting with candy V02
Other: V01 candy
candy with sweetener (Isomalt) and apple flavour
Other: V02 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)
Other: V03 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C
Other: V04 candy
candy with sweetener (Isomalt) (control group 1)
Other: V05 candy
candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)
Experimental: healthy participants starting with candy V03
Other: V01 candy
candy with sweetener (Isomalt) and apple flavour
Other: V02 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)
Other: V03 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C
Other: V04 candy
candy with sweetener (Isomalt) (control group 1)
Other: V05 candy
candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)
Experimental: healthy participants starting with candy V04
Other: V01 candy
candy with sweetener (Isomalt) and apple flavour
Other: V02 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)
Other: V03 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C
Other: V04 candy
candy with sweetener (Isomalt) (control group 1)
Other: V05 candy
candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)
Experimental: healthy participants starting with candy V05
Other: V01 candy
candy with sweetener (Isomalt) and apple flavour
Other: V02 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)
Other: V03 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C
Other: V04 candy
candy with sweetener (Isomalt) (control group 1)
Other: V05 candy
candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dryness of mouth- sensation
Time Frame: one point assessment following consumption of candy (approx 5 minutes)
dryness of mouth- sensation by Visual analogue scale (VAS); 0 = does not apply; 10 = is absolutely true.
one point assessment following consumption of candy (approx 5 minutes)
Change in salivary flow rate (ml/min)
Time Frame: before and after consumption of candy (approx 5 minutes for each salivary flow measurement)
Change in salivary flow rate (ml/min) before and after stimulation (mechanical and gustatory) by consumption of candy
before and after consumption of candy (approx 5 minutes for each salivary flow measurement)

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Investigators

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

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)

December 28, 2020

Primary Completion (Actual)

February 10, 2021

Study Completion (Actual)

February 18, 2021

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 18, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01942; ex19Filippi3

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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