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

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

Detailed Description
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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.

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

Conditions
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Xerostomia

Intervention / Treatment
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* Diagnostic Test: Paraffin Pellets from Aurosan GmbH
* Diagnostic Test: Chewing wax from the Saliva-Check Buffer from GC Europe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stimulated salivary flow rate<br>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 | Diagnostic Test: Paraffin Pellets from Aurosan GmbH<br>* 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.<br>Diagnostic Test: Chewing wax from the Saliva-Check Buffer from GC Europe<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paraffin chewing gum, sialometry, salivary flow rate, mouth dryness