Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect

Not Applicable

Completed

• Conditions: Dental Caries; Periodontal Diseases
• Interventions: Dietary Supplement: 22% Xylitol Gum; Dietary Supplement: 100% Xylitol Gum

• Registration Number: NCT03971981
• Lead Sponsor: Università degli Studi di Sassari

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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Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2018-05-31
• Status Verified: 2019-05
• Study Completion: 2019-05-28
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-31
• Last Update Submitted: 2019-05-31
• Study First Posted: 2019-06-03
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
22% Xylitol	22% Xylitol Gum	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.
100% Xylitol	100% Xylitol Gum	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.

Primary Outcome Measures

Name	Time	Method
Change of Salivary concentration of Xylitol	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.

Trial Locations

Locations (1)

Department of Surgery, Microsurgery and Medicine Sciences University of Sassari; 🇮🇹 Sassari, Sardinia, Italy