Xerostomia
Conditions
Brief summary
This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product.
Interventions
DEVICE8% Arginine toothpaste
Investigative
DRUG1000 ppm F toothpaste
Control
Sponsors
Tufts University
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female volunteers 18- 80 years of age and in general good health. 2. Willing and able to understand and sign the informed consent form. 3. Subjects currently taking at least two medications known to cause xerostomia (dry mouth) as a side effect for the last three months. 4. Be willing to conform to the study protocol and procedures. 5. Polypharmacy subjects must score 4 or more on the VAS scale of 0-10 ("How severe is your dryness right now?"). 6. Flow of 5 minutes unstimulated saliva should be below 0.16 ml/min. 7. 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 study examiner. 8. Minimum of 10 teeth
Exclusion criteria
1. Subjects unable to understand or unwilling to sign the informed consent form. 2. Medical condition which requires premedication prior to dental visits/procedure. 3. Active disease of the hard or soft oral tissues. 4. History of salivary gland disease such as Sjogren's syndrome, Sarcoidosis, or Head and Neck Radiation Therapy. 5. Use of antibiotics or antimicrobial drugs within 30 days prior to study start. 6. Participation in any other clinical study within 1 week prior to enrollment into this study. 7. Subjects who must receive dental treatment during the study dates. 8. Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy). 9. Presence of orthodontic bands. 10. Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1) 11. Use of pilocarpine or other cholinergic stimulating receptor actives prescribed after study enrollment or whose medication dose increases (stable dose for 3 months). 12. People on hormone therapy 13. Pregnant or lactating subjects. 14. Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits; 15. Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary pH Impact | 12 weeks | The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the salivary pH of people with xerostomia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measuring the change in the oral microbiome | 12 weeks | The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the oral microbiome (salivary and whole mouth plaque) of people with xerostomia. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAthena Papas, DMD, PhD
Tufts University School of Dental Medicine
Outcome results
None listed