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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 st…