Clinical trial NCT02992314: Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
Official title: Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Associated Metallic Taste , Dysgeusia
Lead sponsor: You First Services
Sponsor class: INDUSTRY
First posted: 2016-12-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients taking chemotherapeutic agents often do not comply well with their dosing regiment since many of these medications cause a metallic taste in the mouth. The primary intent is to determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth associated with various chemotherapeutic agents. This clinical study a randomized, double-blind, single-treatment, parallel design with a placebo as the control. The duration of the trial will be 1 month.


Eligibility criteria: Inclusion Criteria:

1. Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
2. Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
3. Subject is between the ages of 18 and 75 years inclusive.
4. Subject will not have professional cleaning during the 3-month trial.
5. 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.
6. Subject has a minimum of 16 natural teeth and a complaint of moderate to severe medication associated metallic taste.
7. 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.
8. Subject agrees to refrain from the use of other oral care products not supplied by the study center
9. Subject agrees to be compliant with study procedures.
10. 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:

1. 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).
2. Subject has disqualifying acute or chronic medical illness as judged by the Principal Investigator.
3. Subject is currently taking phenytoin, cyclosporin, nifedipine or any other drug that has been shown to cause gingival enlargement or affect the gingivae.
4. 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.
5. Subject is pregnant (based on pregnancy result) or lactating.

Primary outcomes:
measure: Relief of medication associated metallic taste
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety evaluation of the test Oral Rinse
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY
state: New York
Study officials:
References: