Green Tea Lozenges for the Management of Dry Mouth
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: MighTeaFlow 4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks |
Dietary Supplement: MighTeaFlow
4-6 times daily
Other Names:
|
| Active Comparator: Xylitol 4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks |
Dietary Supplement: Xylitol
4-6 times daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Salivary Flow From Baseline [8 weeks]
Change in salivary flow in Xerostomic patients using Green tea lozenges
Eligibility Criteria
Criteria
Inclusion Criteria:
-
A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth Visual Analog Scale (VAS)
-
Clinical Diagnosis of primary or secondary Sjogren's syndrome.
-
Over the age of 18.
-
Taking less than three drugs associated with causing xerostomia or salivary gland hypofunction.
-
Willing to use natural novel topical dry mouth products.
-
Prior minor salivary gland biopsy and serology from Sjogren's Syndrome/Xerostomia work-up.
-
Willing to return for all study-associated visits.
-
Able to read, understand, and sign the informed consent.
Exclusion Criteria:
-
Have received radiation to the head and neck region.
-
Unable to read and understand the consent form.
-
On greater than three drugs associated with xerostomia or salivary gland hypofunction.
-
Require dento-alveolar surgery or extensive dental treatment during the course of the study.
-
Require hospitalization for any medical problem during the course of the study.
-
Unable to take green tea leaf extract and/or pilocarpus jaborandi leaf extract and/or xylitol because of allergy
-
Uncontrolled medical conditions that require changes in medication during the course of the study.
-
Regularly consume green tea and/or components of pilocarpus jaborandi.
-
Are pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GHSU Center for Oral Medicine | Augusta | Georgia | United States | 30912 |
Sponsors and Collaborators
- Augusta University
- GlaxoSmithKline
Investigators
- Principal Investigator: Scott S De Rossi, DMD, GHSU
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GHSU Lozenge Xerostomia Study
Study Results
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 Detail | Subjects had a diagnosis of Xerostomia |
| Arm/Group Title | Green Tea Lozenge | Placebo |
|---|---|---|
| Arm/Group Description | GTP Green tea lozenge: 4-6 times daily | Xylitol lozenge 4 - 6 times daily |
| Period Title: Overall Study | ||
| STARTED | 30 | 30 |
| COMPLETED | 26 | 25 |
| NOT COMPLETED | 4 | 5 |
Baseline Characteristics
| Arm/Group Title | Green Tea Lozenge | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | GTP Green tea lozenge: 4-6 times daily | Xylitol Green tea lozenge: 4-6 times daily | Total of all reporting groups |
| Overall Participants | 30 | 30 | 60 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
17
56.7%
|
16
53.3%
|
33
55%
|
| >=65 years |
13
43.3%
|
14
46.7%
|
27
45%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
30
100%
|
29
96.7%
|
59
98.3%
|
| Male |
0
0%
|
1
3.3%
|
1
1.7%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
30
100%
|
30
100%
|
60
100%
|
Outcome Measures
| Title | Change in Salivary Flow From Baseline |
|---|---|
| Description | Change in salivary flow in Xerostomic patients using Green tea lozenges |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Enrolled subjects completing 8 weeks of treatment |
| Arm/Group Title | Green Tea Lozenge | Placebo |
|---|---|---|
| Arm/Group Description | GTP Green tea lozenge: 4-6 times daily | Xylitol lozenge 4 - 6 times daily |
| Measure Participants | 26 | 27 |
| Week 0 |
0.17
(0.051)
|
0.10
(0.278)
|
| Week 8 |
0.66
(0.168)
|
0.04
(0.142)
|
Adverse Events
| Time Frame | Adverse event data was collected over a period of 27 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | MighTeaFlow | Xylitol | ||
| Arm/Group Description | 4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks MighTeaFlow: 4-6 times daily | 4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks Xylitol: 4-6 times daily | ||
All Cause Mortality |
||||
| MighTeaFlow | Xylitol | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| MighTeaFlow | Xylitol | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/30 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| MighTeaFlow | Xylitol | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/30 (3.3%) | 2/30 (6.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Allergic Rhinitis | 1/30 (3.3%) | 1 | 2/30 (6.7%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Scot DeRossi, Chairman of the ORal Medicine & Diagnostic Sciences Department |
|---|---|
| Organization | Georgia Regents University |
| Phone | 706-721-2607 |
| Sderossi@gru.edu |
- GHSU Lozenge Xerostomia Study