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Completed

NCT Number: NCT04661761

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

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

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Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Center for Dentistry Basel UZB

Basel, Canton of Basel-City, 4056, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paraffin Pellets from Aurosan GmbH

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

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2020
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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