search
Back to results

Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect

Primary Purpose

Dental Caries, Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
100% Xylitol Gum
22% Xylitol Gum
Sponsored by
Università degli Studi di Sassari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Xylitol, Saliva, Bacteria, Dental Plaque, Antimicrobial effect, Chewing gum

Eligibility Criteria

19 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Department of Surgery, Microsurgery and Medicine Sciences University of Sassari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

100% Xylitol

22% Xylitol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 29, 2019
Last Updated
May 31, 2019
Sponsor
Università degli Studi di Sassari
Collaborators
University of Milan
search

1. Study Identification

Unique Protocol Identification Number
NCT03971981
Brief Title
Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect
Official Title
Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect (In-vivo and In-vitro Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Sassari
Collaborators
University of Milan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
x

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Periodontal Diseases
Keywords
Xylitol, Saliva, Bacteria, Dental Plaque, Antimicrobial effect, Chewing gum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
100% Xylitol
Arm Type
Experimental
Arm Description
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.
Arm Title
22% Xylitol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
100% Xylitol Gum
Intervention Description
Subjects were instructed to consume the gums as they normally would be consumed.
Intervention Type
Dietary Supplement
Intervention Name(s)
22% Xylitol Gum
Intervention Description
Subjects were instructed to consume the gums as they normally would be consumed.
Primary Outcome Measure Information:
Title
Change of Salivary concentration of Xylitol
Description
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.
Time Frame
9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guglielmo Campus
Organizational Affiliation
Università degli Studi di Sassari
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Microsurgery and Medicine Sciences University of Sassari
City
Sassari
State/Province
Sardinia
ZIP/Postal Code
I-07100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect

We'll reach out to this number within 24 hrs