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Green Tea Lozenges for the Management of Dry Mouth

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ClinicalTrials.gov Identifier: NCT01647737
Recruitment Status : Completed
First Posted : July 24, 2012
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Scott DeRossi, Augusta University

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
Xerostomia Sjogren Syndrome Dry Mouth Dietary Supplement: MighTeaFlow Dietary Supplement: Xylitol 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Natural Formulation for Patients Diagnosed With Xerostomia
Study Start Date : March 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth
Drug Information available for: Xylitol

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 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

Primary Outcome Measures :
  1. Change in Salivary Flow From Baseline [ Time Frame: 8 weeks ]
    Change in salivary flow in Xerostomic patients using Green tea lozenges

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647737

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United States, Georgia
GHSU Center for Oral Medicine
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
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Principal Investigator: Scott S De Rossi, DMD GHSU
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Scott DeRossi, Chairman, Diagnostic Sciences, Augusta University
ClinicalTrials.gov Identifier: NCT01647737    
Other Study ID Numbers: GHSU Lozenge Xerostomia Study
First Posted: July 24, 2012    Key Record Dates
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Scott DeRossi, Augusta University:
Sjogren syndrome
dry mouth
Additional relevant MeSH terms:
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Sjogren's Syndrome
Arthritis, Rheumatoid
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