Back to resultsInfluence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
Primary Purpose
Xerostomia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Paraffin Pellets from Aurosan GmbH
Chewing wax from the Saliva-Check Buffer from GC Europe
Sponsored by
About this trial
This is an interventional basic science trial for Xerostomia focused on measuring paraffin chewing gum, sialometry, salivary flow rate, mouth dryness
Eligibility Criteria
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
Sites / Locations
- University Center for Dentistry Basel UZB
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stimulated salivary flow rate
Arm Description
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
Outcomes
Primary Outcome Measures
Stimulated salivary flow rate (ml)
Comparing measurements of stimulated salivary flow rate (ml) after chewing two different chewing gums
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04661761
First Posted
December 1, 2020
Last Updated
April 25, 2022
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT04661761
Brief Title
Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
Official Title
Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
April 24, 2022 (Actual)
Study Completion Date
April 24, 2022 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
paraffin chewing gum, sialometry, salivary flow rate, mouth dryness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stimulated salivary flow rate
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Paraffin Pellets from Aurosan GmbH
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Chewing wax from the Saliva-Check Buffer from GC Europe
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stimulated salivary flow rate (ml)
Description
Comparing measurements of stimulated salivary flow rate (ml) after chewing two different chewing gums
Time Frame
at baseline (approx 40 minutes)
Secondary Outcome Measure Information:
Title
Change in consistency of chewing gum
Description
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
Time Frame
at baseline (7 minutes for each chewing gum)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Filippi, Prof
Organizational Affiliation
University Center for Dentistry Basel UZB
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Center for Dentistry Basel UZB
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4056
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
We'll reach out to this number within 24 hrs