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NCT04554342 Clinical Trial

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

Xerostomia Clinical Trial

— DESERTO  

Official title:
Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity (DESERTO)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04554342
Other study ID # 2020-01942; ex19Filippi3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 28, 2020
Est. completion date February 18, 2021

Study information
Verified date February 2021
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date February 18, 2021
Est. primary completion date February 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• V01 candy
candy with sweetener (Isomalt) and apple flavour
• V02 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)
• V03 candy
candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C
• V04 candy
candy with sweetener (Isomalt) (control group 1)
• V05 candy
candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)

Locations
Country Name City State
Switzerland Universitäres Zentrum für Zahnmedizin Basel Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

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