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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT04661761

Collaborator

(none)

Enrollment

Location

Arm

22.2

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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.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 :

Jun 17, 2020

Actual Primary Completion Date :

Apr 24, 2022

Actual Study Completion Date :

Apr 24, 2022

Arms and Interventions

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.

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

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University Center for Dentistry Basel UZB	Basel	Basel-Stadt	Switzerland	4056

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator: Andreas Filippi, Prof, University Center for Dentistry Basel UZB

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT04661761

Other Study ID Numbers:

2020-00470; ex20Filippi5

First Posted:

Dec 10, 2020

Last Update Posted:

Apr 26, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Basel, Switzerland

Additional relevant MeSH terms:

Xerostomia

Study Results

No Results Posted as of Apr 26, 2022