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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

May 14, 2012
July 23, 2012
March 2011
March 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01647737 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Green Tea Lozenges for the Management of Dry Mouth
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Xerostomia
  • Sjogren Syndrome
  • Dry Mouth
Dietary Supplement: Green tea lozenge
4-6 times daily
  • Active Comparator: Green tea Lozenge
    GTP
    Intervention: Dietary Supplement: Green tea lozenge
  • Placebo Comparator: Placebo
    Xylitol
    Intervention: Dietary Supplement: Green tea lozenge
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
United States
 
NCT01647737
GHSU Lozenge Xerostomia Study
No
Scott DeRossi, Georgia Health Sciences University
Georgia Regents University
International Association for Dental Research
Principal Investigator: Scott S De Rossi, DMD GHSU
Georgia Regents University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP