Intra Oral Application (IOA) Testing Study of a Stannous Toothpaste

Intra Oral Application (IOA) Testing Study of TheraBreath Toothpaste

The primary objective of this crossover in-situ study is to determine the fluoride bioavailability and enamel remineralization potential of an experimental, placebo, and a positive control reference toothpaste.

Each 9-day test period was preceded by a washout period of at least four days during which subjects used a fluoride-free toothpaste. The washout phase ensured removal of residual fluoride exposure prior to beginning the next assigned dentifrice treatment. Subjects remained in good oral health and compliance was verified at the start of each test period.

Inclusion Criteria:

• be 18 years of age or older,

• 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 and sign the Informed Consent and other necessary paperwork prior to initiation of study procedures,

• be in good general and oral health based on medical/dental history,

• have an existing useable dental appliance on file with the clinic or be willing to have one (1) or more dental impressions taken so that a dental appliance can be made to wear during the study,

• have a sufficient functional maxillary dentition to support the palatal appliance, and overall the full (maxillary and mandibular) dentition must provide for proper mastication of food, no less than 16 teeth,

• must be able to expectorate ≥ 1.5 ml of non-stimulated saliva over a 5-minute period*,

• be willing to refrain from using non-study mouthwash, dentifrice, gum, mints, and other non-study oral care products during the entire length of the study (exception: xylitol free gum and mints will be allowed during acclimation/washout periods only),

• 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,

• be willing to refrain from actively participating in another oral care, drug or medical device research study (participation in a marketing/opinion/behavioral study may be allowed so long as the Principal Investigator has provided permission to do so),

• be willing and able to refrain from wearing a nightguard during testing periods (for nightguard wearers only), and

• be willing to postpone all elective dental procedures, at the discretion of the Investigator/Designee, until the study has been completed.

  • Subjects who are unable to provide an adequate amount of saliva during the screening visit may be granted the opportunity to return to the dental clinic to try again (one time only) after adequate hydration.

Exclusion Criteria:

• advanced periodontal disease as characterized by purulent exudate, generalized mobility, etc., or undergoing active treatment for periodontitis,
• pathologic lesions of the oral cavity (suspicious or confirmed; per Investigator/Designee discretion),
• a medical condition that could be expected to interfere with the subject's safety during the study period, such as a true allergy to oral care product ingredients, including (but not limited to) artificial sweeteners, mint (peppermint, spearmint, etc.) or other artificial colors or flavorings, sodium fluoride, ingredients that are derived from seaweed or corn, etc.,
• full dentures, orthodontic appliances (with the exception of a lower, fixed retainer), or other oral devices/appliances or dental work which, at the discretion of the Investigator/Designee, would interfere with the fit of the dental appliance,
• self-reported pregnancy, plans to become pregnant, or is currently breastfeeding,
• allergy/adverse reaction to dental impression materials including Silicon Dioxide, Calcium Sulfate, Magnesium Oxide or Tetrasodium Pyrophosphate,
• any decayed, untreated dental sites (cavities) (per Investigator/Designee discretion),
• having taken antibiotic or immune-suppressive drugs within the past 30 days or anticipating the need to take antibiotic or immune-suppressive drugs during the course of the study (per Investigator/Designee discretion),
• a medical history disclosing a medical condition that has been known to cause individuals to become severely immuno-compromised, or
• a medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc. (per Investigator/Designee discretion).