Saliva AlteredNCT05447104
Salivary Flow Promoted by Sugar-Free Chewing Gum
A study testing Mastication in people with Saliva Altered, run by Mars Wrigley at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Saliva Altered
- What is being tested?
- Mastication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 12 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Therametric Technologies, Inc.
Noblesville, Indiana, 46060
About this study
Official title: 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.
Read the 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.
- Conditions
- Saliva Altered
- Being tested
- Mastication
- Keywords
- "salivary flow rate", saliva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MasticationBehavioural
Chewing sugar-free gum for 20 min
| Study group | Role | What they receive |
|---|---|---|
| ADA Clinically-Tested Reference Sugar-Free Gum | Active comparator | Peppermint flavored sugar-free chewing gum (1 piece = 2.2 grams) Receives: 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) Receives: Behavioral: Mastication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary flow rate
Rate of healthy, adult human salivary flow rate while chewing sugar free gum
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start22 Sep 2021
- Primary completion8 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Saliva AlteredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospectively planned, double-blind, single center cross-over study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mars Wrigley
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce A Matis, Principal investigator, Therametric Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447104
- Sponsor's protocol ID
- M.WRI-2021-SAL-03
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Salivary Flow Promoted by Sugar-Free Chewing Gum in Healthy Adults
- ClinicalTrials.gov ID
- NCT05447104
- Acronym / sponsor ID
- M.WRI-2021-SAL-03
- Conditions
- Saliva Altered
- Keywords
- "salivary flow rate", saliva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mars WrigleyIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospectively planned, double-blind, single center cross-over study
| Arm | Type | Receives |
|---|---|---|
| ADA Clinically-Tested Reference Sugar-Free Gum | Active comparator | Behavioral: MasticationPeppermint flavored sugar-free chewing gum (1 piece = 2.2 grams) |
| Marketed Gum: Sugar-free gum | Experimental | Behavioral: MasticationOrbit White, peppermint flavored sugar-free chewing gum Mars Wrigley Confectionary US, LLC (1 piece = 2.0 grams) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MasticationChewing sugar-free gum for 20 min | Behavioural | ADA Clinically-Tested Reference Sugar-Free Gum, Marketed Gum: Sugar-free gum |
Primary outcome
Salivary flow rate
Time frame: 20 min
Rate of healthy, adult human salivary flow rate while chewing sugar free gum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce A Matis principal investigator
Therametric Technologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mastication in people with Saliva Altered, run by Mars Wrigley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary flow rate (time frame: 20 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.