Evaluation of Anti-biofilm Effects of Ferumoxytol (Feraheme) Using an in Situ Biofilm Demineralization Model

This will be a randomized, crossover, single blind in situ study with three test periods
utilizing 16 subjects. The subjects in this study are lower partial denture wearers who have
already had a study partial denture made for them as a part of a partial denture panel under
14-I-098 (IRB # 1407637739) or who will wear their own lower partial denture which was
previously approved as part of the panel. The study partial dentures or personal partial
dentures can house the specimen holders in two hollowed out areas of the buccal surface of
two posterior denture teeth. The subjects will wear the lower partial dentures with enamel
specimens in place for three consecutive 14-day study periods.

Inclusion Criteria:

1. Males and females 18 to 85 years of age and in good general and oral health without
any known allergies to commercial dental products;

2. Evidence of a personally signed and dated informed consent document indicating the
subject has been informed of all pertinent aspects of the trial;

3. Willingness to use the assigned products according to instructions, availability for
appointments and likelihood of completing the clinical trial;

4. Willing to adhere to the study requirements and restrictions;

5. Lower partial denture wearers who have a lower partial denture made for them as a part
of a partial denture panel under study 14-I-098 (IRB # 1407637739) or who agree to
wear their own pre-approved lower partial denture that can house both specimens on one
side of their partial denture.

Exclusion Criteria:

Oral Examination Inclusion Criteria:

1. Normal salivary flow rate (stimulated and unstimulated flow of ≥ 0.8 mL/min and ≥ 0.2
mL/min, respectively) ascertained from the Screening visit;

2. Willing and capable of wearing the lower partial denture 24 hours a day for the three,
two-week treatment periods. Note: for persons who would otherwise qualify but whose
lower partial denture needs repair, the individual may be listed as "pending". Once
the partial denture has been repaired and adjusted to fit adequately for the subject
to wear the lower partial denture 24 hours a day, the subject may be considered
"qualified", complete their minimum 4 to 5 days washout period (of their own
fluoridated toothpaste use) and continue with visit 2 in the study;

3. Absence of significant oral soft tissue pathology and dental caries, based on the
dentist's visual examination and at the discretion of the investigator. Note: for
persons who would otherwise qualify but who present at screening with dental caries
requiring treatment, the individual may be listed as "pending". If the subject
completes the restorative work within an acceptable amount of time, the subject may be
considered qualified, complete their minimum 4 to 5 day washout period (of their own
fluoridated toothpaste use) and continue with visit 2 in the study; and

4. Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect).

Exclusion Criteria: Subjects presenting with any of the following will not be included in
the trial:

1. Are taking or have ever taken bisphosphonate drugs (i.e., Fosamax, Actonel and Boniva)
for the treatment of osteoporosis;

2. Use of blood thinning medications that prohibit the safe conduct of a dental cleaning
(*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 cleanings, may be accepted into the study);

3. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine,
marijuana, opiates) in the past year;

4. Report allergy to products (Ferumoxytol or other drugs or specific ingredients) used
in the study, a reported history of multiple drug allergies or known hypersensitivity
to any iron products;

5. Scheduled for MRI for the head region within three months after study participation
involving Ferumoxytol application;

6. Have a history of significant adverse effects following the use of oral hygiene
products such as dentifrices and mouth rinses;

7. Use of antimicrobial agents/antibiotics whether prescribed or over-the-counter within
two weeks prior to each treatment visit;

8. Presence of severe marginal gingivitis or moderate/advanced periodontitis based on the
clinical examination and discretion of the dental examiner;

9. Subjects who during the study will receive dental treatment, which may affect their
participation (i.e. oral prophylaxis). Emergency treatment will be allowed if
necessary;

10. Those requiring antibiotic premedication prior to dental treatment;

11. Participation in a dental clinical trial involving oral care products within 30 days
of randomization (Baseline Visit);

12. Self-reported pregnancy or lactation or intent to become pregnant during the study
period;

13. Self-reported chewing tobacco user;

14. Subjects who were previously screened and ineligible or were randomized to receive
investigational product;

15. Significant unstable or uncontrolled medical condition, which may interfere with a
subject's participation in the study;

16. Subjects who are related to those persons involved directly or indirectly with the
conduct of this study; and

17. Other severe, acute or chronic, medical or psychiatric condition(s) or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

If the subject reports taking medication, a history of allergy, and/or a chronic disease
which in the opinion of the investigator will not affect the clinical parameter(s) being
assessed in this study or the safety of the subject, the subject may be enrolled in the
study and it will be noted on the Investigator's source document.