Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect

NCT03971981 | Completed

• 1 other identifier: SS-15884-GC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Periodontal Diseases

Keywords

Xylitol; Saliva; Bacteria; Dental Plaque; Antimicrobial effect; Chewing gum

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

100% Xylitol

EXPERIMENTAL

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

22% Xylitol

EXPERIMENTAL

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

Interventions

100% Xylitol Gum DIETARY_SUPPLEMENT

Subjects were instructed to consume the gums as they normally would be consumed.

100% Xylitol

22% Xylitol Gum DIETARY_SUPPLEMENT

Subjects were instructed to consume the gums as they normally would be consumed.

22% Xylitol

Eligibility Criteria

• Age: 19 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• good general health,
• the absence of diseases that can alter the saliva secretion rate
• a stimulated saliva flow at least of 1 ml/min.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead
• University of Milan: collaborator

Study Sites (1)

Department of Surgery, Microsurgery and Medicine Sciences University of Sassari

Sassari, Sardinia, I-07100, Italy

Location

MeSH Terms

Conditions

Dental Caries; Periodontal Diseases; Dental Plaque

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Mouth Diseases; Dental Deposits

Study Officials

• Guglielmo Campus

  Università degli Studi di Sassari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Public Health Dentistry

Model Details: 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 Record Dates

• First Submitted: May 29, 2019
• First Posted: June 3, 2019
• Study Start: February 1, 2018
• Primary Completion: May 31, 2018
• Study Completion: May 28, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)