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

NCT ID: NCT04554342

Last Updated: 2021-02-21

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-28

Study Completion Date

2021-02-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Xerostomia Dryness of Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

doppel- blind testing of 5 different variations of a candy in each participant by (unstimulated and stimulated) salivary flow rate; each participant is testing each variation of candy once in a randomized order at 5 consecutive days
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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healthy participants starting with candy V01

healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison)

Group Type EXPERIMENTAL

V01 candy

Intervention Type OTHER

candy with sweetener (Isomalt) and apple flavour

V02 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)

V03 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C

V04 candy

Intervention Type OTHER

candy with sweetener (Isomalt) (control group 1)

V05 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)

healthy participants starting with candy V02

Group Type EXPERIMENTAL

V01 candy

Intervention Type OTHER

candy with sweetener (Isomalt) and apple flavour

V02 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)

V03 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C

V04 candy

Intervention Type OTHER

candy with sweetener (Isomalt) (control group 1)

V05 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)

healthy participants starting with candy V03

Group Type EXPERIMENTAL

V01 candy

Intervention Type OTHER

candy with sweetener (Isomalt) and apple flavour

V02 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)

V03 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C

V04 candy

Intervention Type OTHER

candy with sweetener (Isomalt) (control group 1)

V05 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)

healthy participants starting with candy V04

Group Type EXPERIMENTAL

V01 candy

Intervention Type OTHER

candy with sweetener (Isomalt) and apple flavour

V02 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)

V03 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C

V04 candy

Intervention Type OTHER

candy with sweetener (Isomalt) (control group 1)

V05 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)

healthy participants starting with candy V05

Group Type EXPERIMENTAL

V01 candy

Intervention Type OTHER

candy with sweetener (Isomalt) and apple flavour

V02 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)

V03 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C

V04 candy

Intervention Type OTHER

candy with sweetener (Isomalt) (control group 1)

V05 candy

Intervention Type OTHER

candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)

Interventions

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V01 candy

candy with sweetener (Isomalt) and apple flavour

Intervention Type OTHER

V02 candy

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)

Intervention Type OTHER

V03 candy

candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C

Intervention Type OTHER

V04 candy

candy with sweetener (Isomalt) (control group 1)

Intervention Type OTHER

V05 candy

candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)

Intervention Type OTHER

Eligibility Criteria

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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
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. Dr. med. dent.

Role: PRINCIPAL_INVESTIGATOR

Universitäres Zentrum für Zahnmedizin Basel

Locations

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Universitäres Zentrum für Zahnmedizin Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-01942; ex19Filippi3

Identifier Type: -

Identifier Source: org_study_id

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