Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971981
• Other study ID #: SS-15884-GC
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: May 28, 2019

Study information

• Verified date: May 2019
• Source: Università degli Studi di Sassari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 28, 2019
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 26 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Dental Caries
• Periodontal Diseases

Intervention

Dietary Supplement:
• 100% Xylitol Gum
Subjects were instructed to consume the gums as they normally would be consumed.
• 22% Xylitol Gum
Subjects were instructed to consume the gums as they normally would be consumed.

Locations

Country	Name	City	State
Italy	Department of Surgery, Microsurgery and Medicine Sciences University of Sassari	Sassari	Sardinia

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Sassari	University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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