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

NCT ID: NCT04661761

Last Updated: 2022-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-17

Study Completion Date

2022-04-24

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.

Conditions

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Xerostomia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Paraffin Pellets from Aurosan GmbH

Intervention Type DIAGNOSTIC_TEST

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.

Chewing wax from the Saliva-Check Buffer from GC Europe

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Filippi, Prof

Role: PRINCIPAL_INVESTIGATOR

University Center for Dentistry Basel UZB

Locations

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University Center for Dentistry Basel UZB

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-00470; ex20Filippi5

Identifier Type: -

Identifier Source: org_study_id

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