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NCT04661761 Clinical Trial

Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate

Xerostomia Clinical Trial

Official title:
Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04661761
Other study ID # 2020-00470; ex20Filippi5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 17, 2020
Est. completion date April 24, 2022

Study information
Verified date April 2022
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study examines two different chewing gums with regard to consistency and its influence on the result of sialometry

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.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date April 24, 2022
Est. primary completion date April 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - healthy volunteers - non-smoker - no medication Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Paraffin Pellets from Aurosan GmbH
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 Europe
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.

Locations
Country Name City State
Switzerland University Center for Dentistry Basel UZB Basel Basel-Stadt

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stimulated salivary flow rate (ml) Comparing measurements of stimulated salivary flow rate (ml) after chewing two different chewing gums at baseline (approx 40 minutes)
Secondary 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 at baseline (7 minutes for each chewing gum)
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