XerostomiaNCT04661761
Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
A study testing Paraffin Pellets from Aurosan GmbH and Chewing wax from the Saliva-Check Buffer from GC Europe in people with Xerostomia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The study examines two different chewing gums with regard to consistency and its influence on the result of sialometry Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Xerostomia
- What is being tested?
- Paraffin Pellets from Aurosan GmbH and Chewing wax from the Saliva-Check Buffer from GC Europe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jun 2020to 24 Apr 2022
- 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
- healthy volunteers
- non-smoker
- no medication
Who cannot join
- physical or mental illnesses
- smokers
- regular medication intake
- pregnant women
- dementia or persons who are unable to judge or persons with guardianship
- minor test persons
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Center for Dentistry Basel UZB
Basel, Canton of Basel-City, 4056
About this study
The study examines two different chewing gums with regard to consistency and its influence on the result of sialometry
Read the detailed description
The examination (sialometry) is performed on healthy volunteers. The volunteers must chew on a paraffin gum for seven minutes. After each minute, the amount of secreted saliva is spat into a designated cup and evaluated. This test is performed with Aurosan chewing gum and later with GC Europe chewing gum.
- Conditions
- Xerostomia
- Being tested
- Paraffin Pellets from Aurosan GmbH, Chewing wax from the Saliva-Check Buffer from GC Europe
- Keywords
- paraffin chewing gum, sialometry, salivary flow rate, mouth dryness
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraffin Pellets from Aurosan GmbHDiagnostic test
1 to 2 minutes pre-chewing time chewing Paraffin Pellets from Aurosan GmbH, after which the amount of saliva is collected over a period of five minutes. The patient may chew the chewing gum once per second; after each minute the produced amount of saliva is spit in a cup, the whole amount measured after 5 minutes.
Chewing wax from the Saliva-Check Buffer from GC EuropeDiagnostic test
1 to 2 minutes pre-chewing time chewing wax from the Saliva-Check Buffer from GC Europe, after which the amount of saliva is collected over a period of five minutes. The patient may chew the chewing gum once per second; after each minute the produced amount of saliva is spit in a cup, the whole amount measured after 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| stimulated salivary flow rate | Experimental | stimulated salivary flow rate determined in a crossover design: first using Paraffin Pellets from Aurosan GmbH; thereafter using Chewing wax from the Saliva-Check Buffer from GC Europe Receives: Diagnostic Test: Paraffin Pellets from Aurosan GmbH; Diagnostic Test: Chewing wax from the Saliva-Check Buffer from GC Europe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulated salivary flow rate (ml)
Comparing measurements of stimulated salivary flow rate (ml) after chewing two different chewing gums
Measured: at baseline (approx 40 minutes)
Secondary outcomes (1)
Change in consistency of chewing gum
Change in consistency (compressive strength, measured in Newton) of the chewing gums for stimulated salivary flow rate measurement over a time period of 7 minutes chewing time
Measured: at baseline (7 minutes for each chewing gum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start17 Jun 2020
- Primary completion24 Apr 2022
- Study completion24 Apr 2022
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Determination of salivary flow rate chewing Paraffin pellets (manufactured by Aurosan GmbH) for 7 minutes. At a later timepoint determination of salivary flow rate chewing Saliva-Check Buffer (manufactured by GC Europe) for 7 minutes.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Filippi, Prof, Principal investigator, University Center for Dentistry Basel UZB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661761
- Sponsor's protocol ID
- 2020-00470; ex20Filippi5
- Status last verified
- Apr 2022
- First submitted
- 1 Dec 2020
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
- ClinicalTrials.gov ID
- NCT04661761
- Acronym / sponsor ID
- 2020-00470; ex20Filippi5
- Conditions
- Xerostomia
- Keywords
- paraffin chewing gum, sialometry, salivary flow rate, mouth dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 24 Apr 2022 (actual)
- Study completion
- 24 Apr 2022 (actual)
- First posted
- 10 Dec 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.
The study examines two different chewing gums with regard to consistency and its influence on the result of sialometry
Detailed description
The examination (sialometry) is performed on healthy volunteers. The volunteers must chew on a paraffin gum for seven minutes. After each minute, the amount of secreted saliva is spat into a designated cup and evaluated. This test is performed with Aurosan chewing gum and later with GC Europe chewing gum.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Determination of salivary flow rate chewing Paraffin pellets (manufactured by Aurosan GmbH) for 7 minutes. At a later timepoint determination of salivary flow rate chewing Saliva-Check Buffer (manufactured by GC Europe) for 7 minutes.
| Arm | Type | Receives |
|---|---|---|
| stimulated salivary flow rate | Experimental | Diagnostic Test: Paraffin Pellets from Aurosan GmbH, Diagnostic Test: Chewing wax from the Saliva-Check Buffer from GC Europestimulated salivary flow rate determined in a crossover design: first using Paraffin Pellets from Aurosan GmbH; thereafter using Chewing wax from the Saliva-Check Buffer from GC Europe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy volunteers
- non-smoker
- no medication
Key exclusion criteria (6 listed)
- physical or mental illnesses
- smokers
- regular medication intake
- pregnant women
- dementia or persons who are unable to judge or persons with guardianship
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 |
|---|---|---|
| Paraffin Pellets from Aurosan GmbH1 to 2 minutes pre-chewing time chewing Paraffin Pellets from Aurosan GmbH, after which the amount of saliva is collected over a period of five minutes. The patient may chew the chewing gum once per second; after each minute the produced amount of saliva is spit in a cup, the whole amount measured after 5 minutes. | Diagnostic test | stimulated salivary flow rate |
| Chewing wax from the Saliva-Check Buffer from GC Europe1 to 2 minutes pre-chewing time chewing wax from the Saliva-Check Buffer from GC Europe, after which the amount of saliva is collected over a period of five minutes. The patient may chew the chewing gum once per second; after each minute the produced amount of saliva is spit in a cup, the whole amount measured after 5 minutes. | Diagnostic test | stimulated salivary flow rate |
Primary outcome
Stimulated salivary flow rate (ml)
Time frame: at baseline (approx 40 minutes)
Comparing measurements of stimulated salivary flow rate (ml) after chewing two different chewing gums
1 secondary outcome
Change in consistency of chewing gum
Time frame: at baseline (7 minutes for each chewing gum)
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 26 Apr 2022.
- Individual participant dataSharing planned: No
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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 principal investigator
University Center for Dentistry Basel UZB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraffin Pellets from Aurosan GmbH and Chewing wax from the Saliva-Check Buffer from GC Europe in people with Xerostomia, 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 3 inclusion and 6 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 26 Apr 2022. 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?
Stimulated salivary flow rate (ml) (time frame: at baseline (approx 40 minutes)). 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 26 Apr 2022.