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

Not Applicable

Completed

• Conditions: Xerostomia
• Interventions: Diagnostic Test: Paraffin Pellets from Aurosan GmbH; Diagnostic Test: Chewing wax from the Saliva-Check Buffer from GC Europe

• Registration Number: NCT04661761
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2020-06-17
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Status Verified: 2022-04
• Primary Completion: 2022-04-24
• Study Completion: 2022-04-24
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stimulated salivary flow rate	Chewing wax from the Saliva-Check Buffer from GC Europe	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
stimulated salivary flow rate	Paraffin Pellets from Aurosan GmbH	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

Primary Outcome Measures

Name	Time	Method
Stimulated salivary flow rate (ml)	at baseline (approx 40 minutes)	Comparing measurements of stimulated salivary flow rate (ml) after chewing two different chewing gums

Secondary Outcome Measures

Name	Time	Method
Change in consistency of chewing gum	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

Trial Locations

Locations (1)

University Center for Dentistry Basel UZB; 🇨🇭 Basel, Basel-Stadt, Switzerland