Phase
Condition
Saliva And Salivary Gland Dysfunction
Dry Mouth
Treatment
Tom's of Maine Rapid Relief toothpaste
1000 ppm F toothpaste
8% Arginine toothpaste
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female volunteers 18- 80 years of age and in general good health.
Willing and able to understand and sign the informed consent form.
Subjects currently taking at least two medications known to cause xerostomia (drymouth) as a side effect for the last three months.
Be willing to conform to the study protocol and procedures.
Polypharmacy subjects must score 4 or more on the VAS scale of 0-10 ("How severe isyour dryness right now?").
Flow of 5 minutes unstimulated saliva should be below 0.16 ml/min.
No known history of allergy to personal care/consumer products or their ingredients,relevant to any ingredients in the test products as determined by the studyexaminer.
Minimum of 10 teeth
Exclusion
Exclusion Criteria:
Subjects unable to understand or unwilling to sign the informed consent form.
Medical condition which requires premedication prior to dental visits/procedure.
Active disease of the hard or soft oral tissues.
History of salivary gland disease such as Sjogren's syndrome, Sarcoidosis, or Headand Neck Radiation Therapy.
Use of antibiotics or antimicrobial drugs within 30 days prior to study start.
Participation in any other clinical study within 1 week prior to enrollment intothis study.
Subjects who must receive dental treatment during the study dates.
Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
Presence of orthodontic bands.
Current smokers (if former smoker, should have stopped at least 1 month prior toVisit 1)
Use of pilocarpine or other cholinergic stimulating receptor actives prescribedafter study enrollment or whose medication dose increases (stable dose for 3months).
People on hormone therapy
Pregnant or lactating subjects.
Medical condition which prohibits not eating/drinking or chewing gum for four (4)hours prior to your scheduled visits;
Subjects who have an infectious disease and/or other blood borne diseases (Hepatitisseries, HIV, tuberculosis).
Study Design
Connect with a study center
Tufts University School of Dental Medicine
Boston, Massachusetts 02111
United StatesActive - Recruiting
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