Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect

Study Overview
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Brief Summary
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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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x

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

Conditions
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Dental Caries, Periodontal Diseases

Intervention / Treatment
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* Dietary Supplement: 100% Xylitol Gum
* Dietary Supplement: 22% Xylitol Gum


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100% Xylitol<br>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<br>* Subjects were instructed to consume the gums as they normally would be consumed.<br>|
| Experimental: 22% Xylitol<br>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<br>* Subjects were instructed to consume the gums as they normally would be consumed.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xylitol, Saliva, Bacteria, Dental Plaque, Antimicrobial effect, Chewing gum