Green Tea Lozenges for the Management of Dry Mouth

March 17, 2015 updated by: Scott DeRossi, Augusta University

A Natural Formulation for Patients Diagnosed With Xerostomia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • GHSU Center for Oral Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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:
  • 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 Names:
  • Aspartame

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Salivary Flow From Baseline
Time Frame: 8 weeks
Change in salivary flow in Xerostomic patients using Green tea lozenges
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Scott S De Rossi, DMD, GHSU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 24, 2012

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHSU Lozenge Xerostomia Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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