Salivary Flow Promoted by Sugar-Free Chewing Gum

NCT05447104 | Completed

• 1 other identifier: M.WRI-2021-SAL-03
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Saliva Altered

Keywords

"salivary flow rate", saliva

Outcome Measures

Primary Outcomes (1)

• Salivary flow rate

  Rate of healthy, adult human salivary flow rate while chewing sugar free gum

  20 min

Study Arms (2)

ADA Clinically-Tested Reference Sugar-Free Gum

ACTIVE COMPARATOR

Peppermint flavored sugar-free chewing gum (1 piece = 2.2 grams)

Behavioral: Mastication

Marketed Gum: Sugar-free gum

EXPERIMENTAL

Orbit White, peppermint flavored sugar-free chewing gum Mars Wrigley Confectionary US, LLC (1 piece = 2.0 grams)

Behavioral: Mastication

Interventions

Mastication BEHAVIORAL

Chewing sugar-free gum for 20 min

ADA Clinically-Tested Reference Sugar-Free Gum; Marketed Gum: Sugar-free gum

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Mars Wrigley: lead

Study Sites (1)

Therametric Technologies, Inc.

Noblesville, Indiana, 46060, United States

Location

MeSH Terms

Interventions

Mastication

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Bruce A Matis

  Therametric Technologies, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospectively planned, double-blind, single center cross-over study

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: September 22, 2021
• Primary Completion: November 8, 2021
• Study Completion: November 12, 2021
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)