Dry Mouth, Sjogren Syndrome, Xerostomia
Conditions
Keywords
Xerostomia, Sjogren syndrome, dry mouth
Brief summary
The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia patent pending formulation of natural plant extracts on patients with xerostomia. The major component of this formulation is green tea extract with a defined composition of polyphenols. Epidemiological studies suggest that phytochemicals in green tea possess beneficial effects on autoimmune and inflammatory diseases. Thus far, there is little evidence to indicate any marked and direct immunomodulatory effect of green tea on T or B lymphocytes. However, there is considerable evidence for green tea polyphenols (GTPs), major phytochemicals found in green tea extract, having properties consistent with effects on cells of tissues that would be protective towards local inflammation.
Detailed description
Patients with subjective complaints of xerostomia will be given a screening questionnaire to complete. If they meet the criteria on this screening form, the research coordinator will be notified and will meet with the patient either immediately or at a scheduled follow-up appointment. The research coordinator will review the information and then explain the details of the study to the patient and obtain informed consent. Once the patient has signed the informed consent, the research coordinator will collect the demographic, medical history, and contact information from the patient. Any information missing will be noted for follow-up investigation by the research coordinator. If a subject is of child bearing age, they will be asked to complete a urine pregnancy test prior to enrollment.\[a\] First appointment -Screening, consent. \[b\]Follow appointments- review, then Patients will do VAS questionnaire, QOL questionnaire, Sialometry will be done measuring unstimulated whole saliva and Stimulated whole saliva for 5 min each.
Interventions
DIETARY_SUPPLEMENTMighTeaFlow
4-6 times daily
DIETARY_SUPPLEMENTXylitol
4-6 times daily
Sponsors
Augusta University
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth Visual Analog Scale (VAS) 2. Clinical Diagnosis of primary or secondary Sjogren's syndrome. 3. Over the age of 18. 4. Taking less than three drugs associated with causing xerostomia or salivary gland hypofunction. 5. Willing to use natural novel topical dry mouth products. 6. Prior minor salivary gland biopsy and serology from Sjogren's Syndrome/Xerostomia work-up. 7. Willing to return for all study-associated visits. 8. Able to read, understand, and sign the informed consent.
Exclusion criteria
1. Have received radiation to the head and neck region. 2. Unable to read and understand the consent form. 3. On greater than three drugs associated with xerostomia or salivary gland hypofunction. 4. Require dento-alveolar surgery or extensive dental treatment during the course of the study. 5. Require hospitalization for any medical problem during the course of the study. 6. Unable to take green tea leaf extract and/or pilocarpus jaborandi leaf extract and/or xylitol because of allergy 7. Uncontrolled medical conditions that require changes in medication during the course of the study. 8. Regularly consume green tea and/or components of pilocarpus jaborandi. 9. Are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Salivary Flow From Baseline | 8 weeks | Change in salivary flow in Xerostomic patients using Green tea lozenges |
Countries
United States
Participant flow
Recruitment details
Potential candidates were identified from a pool of previously diagnosed subjects and new subjects referred to the Clinical Center for Oral Medicine, School of Dentistry, Georgia Regents University
Pre-assignment details
Subjects had a diagnosis of Xerostomia
Participants by arm
| Arm | Count |
|---|---|
| Green Tea Lozenge GTP
Green tea lozenge: 4-6 times daily | 30 |
| Placebo Xylitol
Green tea lozenge: 4-6 times daily | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Green Tea Lozenge | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 16 Participants | 33 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 30 Participants | 29 Participants | 59 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 30 | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change in Salivary Flow From Baseline
Change in salivary flow in Xerostomic patients using Green tea lozenges
Time frame: 8 weeks
Population: Enrolled subjects completing 8 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Green Tea Lozenge | Change in Salivary Flow From Baseline | Week 0 | 0.17 ml/min | Standard Deviation 0.051 |
| Green Tea Lozenge | Change in Salivary Flow From Baseline | Week 8 | 0.66 ml/min | Standard Deviation 0.168 |
| Placebo | Change in Salivary Flow From Baseline | Week 0 | 0.10 ml/min | Standard Deviation 0.278 |
| Placebo | Change in Salivary Flow From Baseline | Week 8 | 0.04 ml/min | Standard Deviation 0.142 |