Green Tea Lozenges for the Management of Dry Mouth

This study has been completed.
Information provided by (Responsible Party):
Scott DeRossi, Georgia Regents University Identifier:
First received: May 14, 2012
Last updated: March 17, 2015
Last verified: March 2015
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 Intervention Phase
Sjogren Syndrome
Dry Mouth
Dietary Supplement: MighTeaFlow
Dietary Supplement: Xylitol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Natural Formulation for Patients Diagnosed With Xerostomia

Resource links provided by NLM:

Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Change in Salivary Flow From Baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in salivary flow in Xerostomic patients using Green tea lozenges

Enrollment: 60
Study Start Date: March 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Green Tea Lozenge
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 Name: Aspartame

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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01647737

United States, Georgia
GHSU Center for Oral Medicine
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Principal Investigator: Scott S De Rossi, DMD GHSU
  More Information

No publications provided by Georgia Regents University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Scott DeRossi, Chairman, Diagnostic Sciences, Georgia Regents University Identifier: NCT01647737     History of Changes
Other Study ID Numbers: GHSU Lozenge Xerostomia Study
Study First Received: May 14, 2012
Results First Received: January 23, 2015
Last Updated: March 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
Sjogren syndrome
dry mouth

Additional relevant MeSH terms:
Sjogren's Syndrome
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Dry Eye Syndromes
Eye Diseases
Immune System Diseases
Joint Diseases
Lacrimal Apparatus Diseases
Mouth Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases processed this record on November 27, 2015