Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity

Not Applicable

Completed

• Conditions: Xerostomia; Dryness of Mouth
• Interventions: Other: V01 candy; Other: V02 candy; Other: V03 candy; Other: V04 candy; Other: V05 candy

• Registration Number: NCT04554342
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

This study is to investigate whether a candy can increase moisture of the oral cavity and reduce dryness of mouth.

Detailed Description

A candy (available on the market from a Swiss manufacturer (Ricola)), free of ingredients that could interfere with the investigation, is tested in five different versions on different days. It is to analyse whether these candies can increase moisture of the oral cavity and reduce dryness of mouth.

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-18
• Study Start: 2020-12-28
• Status Verified: 2021-02
• Primary Completion: 2021-02-10
• Study Completion: 2021-02-18
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• non- smoker
• no allergies
• no drug- use (except for contraception)
• healthy volunteers (no disease/infection 4 weeks before study participation)

Exclusion Criteria

• pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy participants starting with candy V03	V01 candy	-
healthy participants starting with candy V04	V01 candy	-
healthy participants starting with candy V05	V05 candy	-
healthy participants starting with candy V03	V04 candy	-
healthy participants starting with candy V03	V05 candy	-
healthy participants starting with candy V04	V05 candy	-
healthy participants starting with candy V05	V02 candy	-
healthy participants starting with candy V01	V05 candy	healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison)
healthy participants starting with candy V02	V01 candy	-
healthy participants starting with candy V04	V04 candy	-
healthy participants starting with candy V01	V02 candy	healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison)
healthy participants starting with candy V04	V02 candy	-
healthy participants starting with candy V01	V01 candy	healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison)
healthy participants starting with candy V01	V03 candy	healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison)
healthy participants starting with candy V01	V04 candy	healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison)
healthy participants starting with candy V02	V02 candy	-
healthy participants starting with candy V03	V02 candy	-
healthy participants starting with candy V03	V03 candy	-
healthy participants starting with candy V04	V03 candy	-
healthy participants starting with candy V05	V03 candy	-
healthy participants starting with candy V02	V03 candy	-
healthy participants starting with candy V02	V04 candy	-
healthy participants starting with candy V02	V05 candy	-
healthy participants starting with candy V05	V01 candy	-
healthy participants starting with candy V05	V04 candy	-

Primary Outcome Measures

Name	Time	Method
dryness of mouth- sensation	one point assessment following consumption of candy (approx 5 minutes)	dryness of mouth- sensation by Visual analogue scale (VAS); 0 = does not apply; 10 = is absolutely true.
Change in salivary flow rate (ml/min)	before and after consumption of candy (approx 5 minutes for each salivary flow measurement)	Change in salivary flow rate (ml/min) before and after stimulation (mechanical and gustatory) by consumption of candy

Trial Locations

Locations (1)

Universitäres Zentrum für Zahnmedizin Basel; 🇨🇭 Basel, Switzerland