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

NCT04661761 | Completed

• 1 other identifier: 2020-00470; ex20Filippi5
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Xerostomia

Keywords

paraffin chewing gum; sialometry; salivary flow rate; mouth dryness

Outcome Measures

Primary Outcomes (1)

• Stimulated salivary flow rate (ml)

  Comparing measurements of stimulated salivary flow rate (ml) after chewing two different chewing gums

  at baseline (approx 40 minutes)

Secondary Outcomes (1)

• Change in consistency of chewing gum

  at baseline (7 minutes for each chewing gum)

Study Arms (1)

stimulated salivary flow rate

EXPERIMENTAL

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; Diagnostic Test: Chewing wax from the Saliva-Check Buffer from GC Europe

Interventions

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.

stimulated salivary flow rate

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.

stimulated salivary flow rate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers
• non-smoker
• no medication

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Center for Dentistry Basel UZB

Basel, Canton of Basel-City, 4056, Switzerland

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andreas Filippi, Prof

  University Center for Dentistry Basel UZB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 10, 2020
• Study Start: June 17, 2020
• Primary Completion: April 24, 2022
• Study Completion: April 24, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)