XerostomiaDESERTONCT04554342
Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity
A study testing V01 candy, V02 candy and V03 candy in people with Xerostomia and Dryness of Mouth, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to investigate whether a candy can increase moisture of the oral cavity and reduce dryness of mouth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Xerostomia, Dryness of Mouth
- What is being tested?
- V01 candy, V02 candy and V03 candy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Dec 2020to 18 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non- smoker
- no allergies
- no drug- use (except for contraception)
- healthy volunteers (no disease/infection 4 weeks before study participation)
Who cannot join
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Xerostomia, Dryness of Mouth
- Being tested
- V01 candy, V02 candy, V03 candy, V04 candy, V05 candy
- Keywords
- salivary flow rate, salivary flow stimulation
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V01 candyOther
candy with sweetener (Isomalt) and apple flavour
V02 candyOther
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)
V03 candyOther
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C
V04 candyOther
candy with sweetener (Isomalt) (control group 1)
V05 candyOther
candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)
| Study group | Role | What they receive |
|---|---|---|
| healthy participants starting with candy V01 | Experimental | healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison) Receives: Other: V01 candy; Other: V02 candy; Other: V03 candy; Other: V04 candy; Other: V05 candy |
| healthy participants starting with candy V02 | Experimental | Not described Receives: Other: V01 candy; Other: V02 candy; Other: V03 candy; Other: V04 candy; Other: V05 candy |
| healthy participants starting with candy V03 | Experimental | Not described Receives: Other: V01 candy; Other: V02 candy; Other: V03 candy; Other: V04 candy; Other: V05 candy |
| healthy participants starting with candy V04 | Experimental | Not described Receives: Other: V01 candy; Other: V02 candy; Other: V03 candy; Other: V04 candy; Other: V05 candy |
| healthy participants starting with candy V05 | Experimental | Not described Receives: Other: V01 candy; Other: V02 candy; Other: V03 candy; Other: V04 candy; Other: V05 candy |
What is being measured
The primary outcome is the main question the study is designed to answer.
dryness of mouth- sensation
dryness of mouth- sensation by Visual analogue scale (VAS); 0 = does not apply; 10 = is absolutely true.
Measured: one point assessment following consumption of candy (approx 5 minutes)
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
Measured: before and after consumption of candy (approx 5 minutes for each salivary flow measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start28 Dec 2020
- Primary completion10 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Filippi, Prof. Dr. med. dent., Principal investigator, Universitäres Zentrum für Zahnmedizin Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554342
- Sponsor's protocol ID
- 2020-01942; ex19Filippi3
- Acronym
- DESERTO
- Status last verified
- Feb 2021
- First submitted
- 14 Sep 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity (DESERTO)
- ClinicalTrials.gov ID
- NCT04554342
- Acronym / sponsor ID
- DESERTO / 2020-01942; ex19Filippi3
- Conditions
- Xerostomia, Dryness of Mouth
- Keywords
- salivary flow rate, salivary flow stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- 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
| Arm | Type | Receives |
|---|---|---|
| healthy participants starting with candy V01 | Experimental | Other: V01 candy, Other: V02 candy, Other: V03 candy, Other: V04 candy, Other: V05 candyhealthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison) |
| healthy participants starting with candy V02 | Experimental | Other: V01 candy, Other: V02 candy, Other: V03 candy, Other: V04 candy, Other: V05 candy |
| healthy participants starting with candy V03 | Experimental | Other: V01 candy, Other: V02 candy, Other: V03 candy, Other: V04 candy, Other: V05 candy |
| healthy participants starting with candy V04 | Experimental | Other: V01 candy, Other: V02 candy, Other: V03 candy, Other: V04 candy, Other: V05 candy |
| healthy participants starting with candy V05 | Experimental | Other: V01 candy, Other: V02 candy, Other: V03 candy, Other: V04 candy, Other: V05 candy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non- smoker
- no allergies
- no drug- use (except for contraception)
- healthy volunteers (no disease/infection 4 weeks before study participation)
Key exclusion criteria (1 listed)
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V01 candycandy with sweetener (Isomalt) and apple flavour | Other | 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 |
| V02 candycandy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) | Other | 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 |
| V03 candycandy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C | Other | 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 |
| V04 candycandy with sweetener (Isomalt) (control group 1) | Other | 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 |
| V05 candycandy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2) | Other | 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 |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Filippi, Prof. Dr. med. dent. principal investigator
Universitäres Zentrum für Zahnmedizin Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V01 candy, V02 candy and V03 candy in people with Xerostomia and Dryness of Mouth, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dryness of mouth- sensation (time frame: one point assessment following consumption of candy (approx 5 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.