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CompletedNCT04554342DESERTOUpdated Feb 21, 2021

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

An interventional study of V01 candy and V02 candy in Xerostomia and Dryness of Mouth, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-21.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Xerostomia
  • Dryness of Mouth

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Keywords

  • salivary flow rate
  • salivary flow stimulation
03

In context

Xerostomia

264 studies on the registry are indexed under Xerostomia; 48 are open to participants now.

This study's enrollment of 33 is below the median of 42 across 223 interventional studies indexed under Xerostomia.

Browse Xerostomia studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnant women
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • 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 · Other: V02 candy · Other: V03 candy · Other: V04 candy · Other: V05 candy

  • Experimental
    healthy participants starting with candy V02

    Other: V01 candy · Other: V02 candy · Other: V03 candy · Other: V04 candy · Other: V05 candy

  • Experimental
    healthy participants starting with candy V03

    Other: V01 candy · Other: V02 candy · Other: V03 candy · Other: V04 candy · Other: V05 candy

  • Experimental
    healthy participants starting with candy V04

    Other: V01 candy · Other: V02 candy · Other: V03 candy · Other: V04 candy · Other: V05 candy

  • Experimental
    healthy participants starting with candy V05

    Other: V01 candy · Other: V02 candy · Other: V03 candy · Other: V04 candy · Other: V05 candy

Interventions

  • OtherV01 candy

    candy with sweetener (Isomalt) and apple flavour

  • OtherV02 candy

    candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)

  • OtherV03 candy

    candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C

  • OtherV04 candy

    candy with sweetener (Isomalt) (control group 1)

  • OtherV05 candy

    candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)

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What researchers measure

Primary outcomes

  1. dryness of mouth- sensation

    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)

  2. 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

    Time frame: before and after consumption of candy (approx 5 minutes for each salivary flow measurement)

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Study locations

1 site
  • Universitäres Zentrum für Zahnmedizin Basel
    Basel, 4058, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04554342
Responsible party
Sponsor
First posted
Sep 18, 2020
Start date
Dec 28, 2020
Primary completion
Feb 10, 2021
Completion
Feb 18, 2021
Last update
Feb 21, 2021

Study contacts

Andreas Filippi, Prof. Dr. med. dent.
principal investigator · Universitäres Zentrum für Zahnmedizin Basel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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