Eligibility Details:
Key Inclusion Criteria:
1. Be wearing a removable mandibular partial denture that fits comfortably enough to wear
24 hours a day and willing to have their partial denture modified to accommodate the
enamel test specimens.
2. Have completed and been accepted into the Oral Health Research Institute's screening
for partial denture panel (#110007150).
3. Have no current active caries or periodontal disease that may compromise the trial or
health of the person. Persons exhibiting localized periodontal conditions who, in the
opinion of the trial dentist, will not be negatively affected by participation in
intra-oral studies may be accepted. Persons with caries may participate if the carious
lesions have been restored prior to beginning the first treatment.
4. Be willing to comply with all subjects' responsibilities (be willing and capable of
wearing their removable partial dentures 24 hours per day during the treatment
periods, attend appointments, follow brushing instructions, use non zinc adhesive in
upper denture only etc.).
5. Have an unstimulated salivary flow rate of at least 0.2 ml per minute as determined by
a five-minute salivary flow test at screening and a stimulated salivary flow rate of
at least 0.8 ml per minute as determined by a two-minute stimulated (gum base)
salivary flow test at screening
Key Exclusion Criteria:
1. Currently pregnant, intending to become pregnant during the trial period or
breast-feeding.
2. Have a history of significant adverse effects following use of oral hygiene products
such as toothpastes and mouth rinses.
3. Have any allergy to ingredients in the trial toothpaste products.
4. Currently be taking antibiotics or have taken antibiotics in the two weeks prior to
the beginning the first treatment.
5. Have factors which could contraindicate their participation, such as any condition
requiring the need for antibiotic premedication prior to a dental treatment, a
condition requiring the need for long-term antibiotic use, blood thinning medications*
that prohibit the safe conduct of a dental cleaning* or previous use of the weight
loss medications Fen Phen® or Redux®. *Note: Subjects who are taking blood thinners in
which written verification is obtained from their physician indicating their PT/INR
levels (anti-coagulation blood levels) are at an acceptable level to avoid serious
complications, such as bleeding during dental cleaning, may be accepted into the
trial.
6. Currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®,
Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
7. Currently taking fluoride supplements, required to use a fluoride mouth rinse or have
received a professional fluoride treatment in the two weeks preceding specimen
placement.
8. Participation in another clinical trial/study within 30 days preceding the present
trial/study.