Salivary Flow Promoted by Sugar-Free Chewing Gum

Saliva Altered Clinical Trial

Official title: Assessment of Salivary Flow Promoted by Sugar-Free Chewing Gum in Healthy Adults

Status Completed

Clinical Trial Summary

This was a double-blind, single center in vivo salivary flow rate study. The objective was to compare a marketed sugar-free chewing gum to a clinically-tested sugar-free reference chewing gum, with regards to their ability to promote salivary flow during a 20-minute chew period in healthy human adult subjects. Two sugar-free chewing gums were randomly assigned and distributed in a cross-over fashion to study subjects over two test period visits. The primary response being measured was salivary flow promoted by sugar-free chewing gums during the 20-minute chewing period.

Clinical Trial Description

These procedures were conducted in accordance with proposed guidelines for current good clinical practices. Informed consent was obtained in compliance with FDA regulations (21 CFR 50). Each subject read, understood, signed, and received a signed copy of the most current IRB approved informed consent document prior to any study-related procedures being performed. The test and control gums were provided by the Sponsor. One serving size of each gum type was placed in a labeled, small high barrier foil bag to ensure that the subjects and the site personnel received the gum in a blinded manner. During each of the test visits, subjects: 1) provided a non-stimulated saliva sample to ensure continued qualification, 2) received their assigned chewing gum, and 3) provided stimulated saliva over a timed 20-minute chewing period. The primary response being measured was the salivary flow promoted by each chewing gum. ;

Related Conditions & MeSH terms

• Saliva Altered

• NCT number: NCT05447104
• Study type: Interventional
• Source: Mars Wrigley
• Status: Completed
• Phase: N/A
• Start date: September 22, 2021
• Completion date: November 12, 2021