Green Tea Lozenges for the Management of Dry Mouth

NCT01647737 | Completed Phase 1 Results

• 1 other identifier: GHSU Lozenge Xerostomia Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia; Sjogren Syndrome; Dry Mouth

Keywords

Xerostomia; Sjogren syndrome; dry mouth

Outcome Measures

Primary Outcomes (1)

• Change in Salivary Flow From Baseline

  Change in salivary flow in Xerostomic patients using Green tea lozenges

  8 weeks

Study Arms (2)

MighTeaFlow

ACTIVE COMPARATOR

4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks

Dietary Supplement: MighTeaFlow

Xylitol

ACTIVE COMPARATOR

4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks

Dietary Supplement: Xylitol

Interventions

MighTeaFlow DIETARY_SUPPLEMENT

4-6 times daily

Also known as: Green Tea Lozenge

MighTeaFlow

Xylitol DIETARY_SUPPLEMENT

4-6 times daily

Also known as: Aspartame

Xylitol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

GHSU Center for Oral Medicine

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

• De Rossi SS, Thoppay J, Dickinson DP, Looney S, Stuart M, Ogbureke KU, Hsu S. A phase II clinical trial of a natural formulation containing tea catechins for xerostomia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Oct;118(4):447-454.e3. doi: 10.1016/j.oooo.2014.06.015. Epub 2014 Jul 5.

  PMID: 25240992 DERIVED

MeSH Terms

Conditions

Xerostomia; Sjogren's Syndrome

Interventions

Xylitol; Aspartame

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Scot DeRossi, Chairman of the ORal Medicine & Diagnostic Sciences Department
• Organization: Georgia Regents University

Sderossi@gru.edu

706-721-2607

Study Officials

• Scott S De Rossi, DMD

  GHSU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Diagnostic Sciences

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: July 24, 2012
• Study Start: March 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 18, 2015
• Results First Posted: March 18, 2015

Record last verified: 2015-03

Locations

US (1)