Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT05447104
Eligibility Criteria:
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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05447104
Study Brief:
Protocol Section:
NCT05447104