Green Tea Lozenges for the Management of Dry Mouth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Georgia Regents University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
International Association for Dental Research
Information provided by (Responsible Party):
Scott DeRossi, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT01647737
First received: May 14, 2012
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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
Xerostomia
Sjogren Syndrome
Dry Mouth
Dietary Supplement: Green tea lozenge
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:
  • Improvement in salivary flow from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Improvement in salivary flow in Xerostomic patients using Green tea lozenges


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Green tea Lozenge
GTP
Dietary Supplement: Green tea lozenge
4-6 times daily
Placebo Comparator: Placebo
Xylitol
Dietary Supplement: Green tea lozenge
4-6 times daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01647737

Locations
United States, Georgia
GHSU Center for Oral Medicine Recruiting
Augusta, Georgia, United States, 30912
Contact: SCOTT S DE ROSSI, DMD    706-721-2607    sderossi@georgiahealth.edu   
Contact: LYNNE COUTURE    706.721.2607      
Principal Investigator: SCOTT S DE ROSSI, DMD         
Sub-Investigator: Jaisri R Thoppay, BDS MBA         
Sub-Investigator: Ilanit Stern, BDS         
Sub-Investigator: Kalu Ogbureke, BDS         
Sub-Investigator: Stephen Hsu, PhD         
Sub-Investigator: Douglas Dickinson, PhD         
Sponsors and Collaborators
Georgia Regents University
International Association for Dental Research
Investigators
Principal Investigator: Scott S De Rossi, DMD GHSU
  More Information

No publications provided

Responsible Party: Scott DeRossi, Chairman, Diagnostic Sciences, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01647737     History of Changes
Other Study ID Numbers: GHSU Lozenge Xerostomia Study
Study First Received: May 14, 2012
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
Xerostomia
Sjogren syndrome
dry mouth

Additional relevant MeSH terms:
Sjogren's Syndrome
Xerostomia
Syndrome
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014