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

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ClinicalTrials.gov Identifier: NCT04661761
Recruitment Status : Completed
First Posted : December 10, 2020
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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

Condition or disease Intervention/treatment Phase
Xerostomia Diagnostic Test: Paraffin Pellets from Aurosan GmbH Diagnostic Test: Chewing wax from the Saliva-Check Buffer from GC Europe Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
Actual Study Start Date : June 17, 2020
Actual Primary Completion Date : April 24, 2022
Actual Study Completion Date : April 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth
Drug Information available for: Paraffin

Arms and Interventions
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Arm Intervention/treatment
Experimental: stimulated salivary flow rate
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
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.

Diagnostic Test: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in consistency of chewing gum [ Time Frame: at baseline (7 minutes for each 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661761


Locations
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Switzerland
University Center for Dentistry Basel UZB
Basel, Basel-Stadt, Switzerland, 4056
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Andreas Filippi, Prof University Center for Dentistry Basel UZB
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04661761    
Other Study ID Numbers: 2020-00470; ex20Filippi5
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
paraffin chewing gum
sialometry
salivary flow rate
mouth dryness
Additional relevant MeSH terms:
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Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases