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Lipid Based Food Additives for Treating Patients With Dry Mouth

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ClinicalTrials.gov Identifier: NCT00422370
Recruitment Status : Unknown
Verified December 2006 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : January 17, 2007
Last Update Posted : January 17, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Xerostomia Device: lipid based additives based on vegetable oil & lecithin

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Lipid Based Food Additives for Treating Patients With Dry Mouth
Study Start Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth
Drug Information available for: Lecithin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Improvement in dry mouth symptom

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: January 17, 2007    Key Record Dates
Last Update Posted: January 17, 2007
Last Verified: December 2006

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