Salivary Flow Promoted by Sugar-Free Chewing Gum

July 1, 2022 updated by: Mars Wrigley

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Noblesville, Indiana, United States, 46060
        • Therametric Technologies, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • be at least 18 years of age
  • have the ability to understand the information contained in the informed consent without the need for cognitive or language interpretation from any other person or source
  • read, comprehend and sign the Informed Consent and other necessary paperwork prior to initiation of study procedures
  • be in good general health based on his/her medical and dental history
  • have a reasonably functional dentition with a minimum of 20 natural teeth (8 of which are posterior teeth)
  • chew gum at least occasionally, no less than one time per month
  • have normal salivary flow as demonstrated by being able to expectorate ≥ 1.5 mL (0.3 mL/min) of whole non-stimulated saliva over a 5-minute period
  • be willing to participate in the study, be able to follow the study directions, and be willing to return for all specified visits at their appointed time, and
  • be willing to postpone all elective dental procedures, at the Principal Investigator/Examiner's discretion, until the study has been completed.

Exclusion Criteria:

  • advanced periodontal disease
  • five or more grossly decayed, untreated dental sites (cavities)
  • pathologic lesions of the oral cavity (suspicious or confirmed)
  • full or partial dentures, or fixed orthodontic appliances, with the exception of a fixed, lower lingual retainer
  • (if female) a medical history indicating that the subject is pregnant or currently breastfeeding
  • current participation in another clinical research study or recent participation in another clinical trial (within 30 days of the study start date) may be cause for exclusion, based on the discretion of the Principal Investigator/Dental Examiner
  • a history of a true allergy or intolerance to gum ingredients, including (but not limited to) sweeteners, colors or flavors, mint, peppermint, spearmint, milk proteins, or other ingredients which may be present in the study products
  • Have a serious medical illness or disorder, e.g., immune compromised, AIDs, etc., that would be unduly affected by participation in this study, per the Principal Investigator/Dental Examiner's discretion
  • a history of PKU (an intolerance to phenylalanine)
  • a true food allergy to soy, or
  • a history of temporomandibular disorder (TMD).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: ADA Clinically-Tested Reference Sugar-Free Gum
Peppermint flavored sugar-free chewing gum (1 piece = 2.2 grams)
Behavioral: Mastication
Chewing sugar-free gum for 20 min
Experimental: Marketed Gum: Sugar-free gum
Orbit White, peppermint flavored sugar-free chewing gum Mars Wrigley Confectionary US, LLC (1 piece = 2.0 grams)
Behavioral: Mastication
Chewing sugar-free gum for 20 min

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Salivary flow rate
Time Frame: 20 min
Rate of healthy, adult human salivary flow rate while chewing sugar free gum
20 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mars Wrigley

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bruce A Matis, Therametric Technologies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M.WRI-2021-SAL-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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