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Clinical Trials/NCT03971981
NCT03971981
Completed
Not Applicable

Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect (In-vivo and In-vitro Study)

Università degli Studi di Sassari1 site in 1 country32 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries
Sponsor
Università degli Studi di Sassari
Enrollment
32
Locations
1
Primary Endpoint
Change of Salivary concentration of Xylitol
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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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Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
May 28, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Università degli Studi di Sassari
Responsible Party
Principal Investigator
Principal Investigator

Guglielmo Campus

Professor of Public Health Dentistry

Università degli Studi di Sassari

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Change of Salivary concentration of Xylitol

Time Frame: 9 days

Xylitol concentration using spectrophotometer analysis was determined in saliva before, at 0.30, 1.00, 2.00, 5.00, 10.00 minutes using the chewing-gum, and after the gum discarded at 15.00, 20.00 and 25.00 minutes.

Study Sites (1)

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