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

Primary Purpose

Xerostomia, Dryness of Mouth

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
V01 candy
V02 candy
V03 candy
V04 candy
V05 candy
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring salivary flow rate, salivary flow stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitäres Zentrum für Zahnmedizin Basel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

healthy participants starting with candy V01

healthy participants starting with candy V02

healthy participants starting with candy V03

healthy participants starting with candy V04

healthy participants starting with candy V05

Arm Description

healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison)

Outcomes

Primary Outcome Measures

dryness of mouth- sensation
dryness of mouth- sensation by Visual analogue scale (VAS); 0 = does not apply; 10 = is absolutely true.
Change in salivary flow rate (ml/min)
Change in salivary flow rate (ml/min) before and after stimulation (mechanical and gustatory) by consumption of candy

Secondary Outcome Measures

Full Information

First Posted
September 14, 2020
Last Updated
February 18, 2021
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04554342
Brief Title
Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity
Acronym
DESERTO
Official Title
Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity (DESERTO)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Dryness of Mouth
Keywords
salivary flow rate, salivary flow stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
doppel- blind testing of 5 different variations of a candy in each participant by (unstimulated and stimulated) salivary flow rate; each participant is testing each variation of candy once in a randomized order at 5 consecutive days
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy participants starting with candy V01
Arm Type
Experimental
Arm Description
healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison)
Arm Title
healthy participants starting with candy V02
Arm Type
Experimental
Arm Title
healthy participants starting with candy V03
Arm Type
Experimental
Arm Title
healthy participants starting with candy V04
Arm Type
Experimental
Arm Title
healthy participants starting with candy V05
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
V01 candy
Intervention Description
candy with sweetener (Isomalt) and apple flavour
Intervention Type
Other
Intervention Name(s)
V02 candy
Intervention Description
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)
Intervention Type
Other
Intervention Name(s)
V03 candy
Intervention Description
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C
Intervention Type
Other
Intervention Name(s)
V04 candy
Intervention Description
candy with sweetener (Isomalt) (control group 1)
Intervention Type
Other
Intervention Name(s)
V05 candy
Intervention Description
candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)
Primary Outcome Measure Information:
Title
dryness of mouth- sensation
Description
dryness of mouth- sensation by Visual analogue scale (VAS); 0 = does not apply; 10 = is absolutely true.
Time Frame
one point assessment following consumption of candy (approx 5 minutes)
Title
Change in salivary flow rate (ml/min)
Description
Change in salivary flow rate (ml/min) before and after stimulation (mechanical and gustatory) by consumption of candy
Time Frame
before and after consumption of candy (approx 5 minutes for each salivary flow measurement)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Filippi, Prof. Dr. med. dent.
Organizational Affiliation
Universitäres Zentrum für Zahnmedizin Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäres Zentrum für Zahnmedizin Basel
City
Basel
ZIP/Postal Code
4058
Country
Switzerland

12. IPD Sharing Statement

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

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