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Completed

NCT Number: NCT03971981

Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect

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.

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Key information

Age range

19 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Microsurgery and Medicine Sciences University of Sassari

Sassari, Sardinia, I-07100, Italy

About this study

x

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

100% Xylitol Gum

Dietary Supplement

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

22% Xylitol Gum

Dietary Supplement

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Sassari

Other

Collaborators

  • University of Milan

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 3, 2019
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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