Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste

Inclusion criteria

• Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
• Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
• Subject is between the ages of 18 and 75 years inclusive.
• Subject will not have professional cleaning during the 3-month trial.
• Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
• Subject has a minimum of 16 natural teeth and a complaint of moderate to severe medication associated metallic taste.
• Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Colgate® Cavity Protection Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study.
• Subject agrees to refrain from the use of other oral care products not supplied by the study center
• Subject agrees to be compliant with study procedures.
• Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy testing at the first and second visit.

Exclusion criteria

• Subject has a condition that requires prophylactic antibiotics for dental examinations and treatments (e.g., has a history of valvular heart disease or a recently placed prosthetic joint).
• Subject has disqualifying acute or chronic medical illness as judged by the Principal Investigator.
• Subject is currently taking phenytoin, cyclosporin, nifedipine or any other drug that has been shown to cause gingival enlargement or affect the gingivae.
• Subject has taken antibiotics, steroids, or non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen) within one week prior to baseline examination. Subjects taking long-term aspirin (81 mg/day) may be included in the trial, but subjects taking a larger dose will be excluded. Subjects taking blood thinners such as Coumadin (warfarin), Lovenox, or Plavix will be excluded.
• Subject is pregnant (based on pregnancy result) or lactating.