Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect

NCT ID: NCT03971981

Last Updated: 2019-06-03

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-05-28

Brief Summary

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a double-blind cross-over in vivo study was performed to measure the salivary concentration of Xylitol released from the two chewing gums containing different amount of the polyol. The study had a cross-over design: the first half of the sample used the chewing-gum with Xylitol as the only sweeteners (64.5% of chewing-gum weight) and the other half use the chewing-gum with Xylitol among the sweeteners (22% of chewing-gum weight), after a 7-days wash-out period, the two sub-groups inverted the chewing gums. Subjects were instructed to consume the products as they normally would be consumed.

Detailed Description

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Conditions

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Dental Caries Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

a double-blind cross-over in vivo study was performed to measure the salivary concentration of Xylitol released from the two chewing gums containing different amount of the polyol. The study had a cross-over design: the first half of the sample used the chewing-gum with Xylitol as the only sweeteners (64.5% of chewing-gum weight) and the other half use the chewing-gum with Xylitol among the sweeteners (22% of chewing-gum weight), after a 7-days wash-out period, the two sub-groups inverted the chewing gums. Subjects were instructed to consume the products as they normally would be consumed.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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100% Xylitol

The study had a cross-over design: the first half of the sample used the chewing-gum with Xylitol as the only sweeteners (64.5% of chewing-gum weight) and the other half use the chewing-gum with Xylitol among the sweeteners (22% of chewing-gum weight), after a 7-days wash-out period, the two sub-groups inverted the chewing gums.

Group Type EXPERIMENTAL

100% Xylitol Gum

Intervention Type DIETARY_SUPPLEMENT

Subjects were instructed to consume the gums as they normally would be consumed.

22% Xylitol

The study had a cross-over design: the first half of the sample used the chewing-gum with Xylitol as the only sweeteners (64.5% of chewing-gum weight) and the other half use the chewing-gum with Xylitol among the sweeteners (22% of chewing-gum weight), after a 7-days wash-out period, the two sub-groups inverted the chewing gums.

Group Type EXPERIMENTAL

22% Xylitol Gum

Intervention Type DIETARY_SUPPLEMENT

Subjects were instructed to consume the gums as they normally would be consumed.

Interventions

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100% Xylitol Gum

Subjects were instructed to consume the gums as they normally would be consumed.

Intervention Type DIETARY_SUPPLEMENT

22% Xylitol Gum

Subjects were instructed to consume the gums as they normally would be consumed.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* good general health,
* the absence of diseases that can alter the saliva secretion rate
* a stimulated saliva flow at least of 1 ml/min.

Exclusion Criteria

\-
Minimum Eligible Age

19 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Milan

OTHER

Sponsor Role collaborator

Università degli Studi di Sassari

OTHER

Sponsor Role lead

Responsible Party

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Guglielmo Campus

Professor of Public Health Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guglielmo Campus

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Sassari

Locations

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Department of Surgery, Microsurgery and Medicine Sciences University of Sassari

Sassari, Sardinia, Italy

Site Status

Countries

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Italy

Other Identifiers

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SS-15884-GC

Identifier Type: -

Identifier Source: org_study_id

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