- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05447104
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
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
Interventional
Enrollment (Actual)
16
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
Active Comparator: ADA Clinically-Tested Reference Sugar-Free Gum
Peppermint flavored sugar-free chewing gum (1 piece = 2.2 grams)
|
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)
|
Chewing sugar-free gum for 20 min
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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)
September 22, 2021
Primary Completion (Actual)
November 8, 2021
Study Completion (Actual)
November 12, 2021
Study Registration Dates
First Submitted
July 1, 2022
First Submitted That Met QC Criteria
July 1, 2022
First Posted (Actual)
July 7, 2022
Study Record Updates
Last Update Posted (Actual)
July 7, 2022
Last Update Submitted That Met QC Criteria
July 1, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID 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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