We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lipid Based Food Additives for Treating Patients With Dry Mouth

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422370
First Posted: January 17, 2007
Last Update Posted: July 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
Over 10% of adult population suffers from dry mouth (xerostomia). The aim of this double blind prospective clinical trial is to examine a new lipid based food additive formulation to ease mouth dryness in these patients.

Condition Intervention
Xerostomia Device: lipid based additives based on vegetable oil & lecithin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Lipid Based Food Additives for Treating Patients With Dry Mouth

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Improvement in dry mouth symptom

Estimated Enrollment: 20
Study Start Date: January 2007
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dry mouth patients

Exclusion Criteria:

  • Disabled patients
  • Pregnant
  • Full upper denture
  • Under 18 years old
  Contacts and Locations
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): NCT00422370


Contacts
Contact: Doron J Aframian, DMD PhD 0097226776151 daframian@yahoo.com

Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Chair: Doron J Aframian, DMD PhD Reference: Kelly HM et al. Bioadhesive,rheological, lubricant and other aspectes of an oral gel formulation intended for the treatment of xerostomia. Int J Phramac. 2004; 278: 391-406
Study Chair: Doron J Aframian, DMD PhD Salivary Gland Clinic, Department of Oral Medicine The Hebrew University-Hadassah School of Dental Medicine Jerusalem, Israel P.O.B 12272, Zip code 91120
  More Information

ClinicalTrials.gov Identifier: NCT00422370     History of Changes
Other Study ID Numbers: 38-29.12.06
First Submitted: December 14, 2006
First Posted: January 17, 2007
Last Update Posted: July 25, 2007
Last Verified: December 2006

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases