Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Dental Caries
• Intervention / Treatment: Dietary supplement: 100% Xylitol Gum; Dietary supplement: 22% Xylitol Gum

Detailed Description

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• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Sardinia
    • Sassari, Sardinia, Italy, I-07100
      • Department of Surgery, Microsurgery and Medicine Sciences University of Sassari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 26 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Dietary supplement: 100% Xylitol Gum; Subjects were instructed to consume the gums as they normally would be consumed.
EXPERIMENTAL: 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.	Dietary supplement: 22% Xylitol Gum; Subjects were instructed to consume the gums as they normally would be consumed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Salivary concentration of Xylitol	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.	9 days

Collaborators and Investigators

• Sponsor: Università degli Studi di Sassari
• Collaborators: University of Milan
• Investigators: Principal Investigator: Guglielmo Campus, Università degli Studi di Sassari

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): May 31, 2018
• Study Completion (ACTUAL): May 28, 2019

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (ACTUAL): June 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Bacteria; Saliva; Chewing gum; Xylitol; Dental Plaque; Antimicrobial effect
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Periodontal Diseases
• Other Study ID Numbers: SS-15884-GC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No