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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
Information provided by:
Hadassah Medical Organization Identifier:
First received: December 14, 2006
Last updated: January 16, 2007
Last verified: December 2006
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
Device: lipid based additives based on vegetable oil & lecithin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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

Inclusion Criteria:

  • Dry mouth patients

Exclusion Criteria:

  • Disabled patients
  • Pregnant
  • Full upper denture
  • Under 18 years old
  Contacts and Locations
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Please refer to this study by its identifier: NCT00422370

Contact: Doron J Aframian, DMD PhD 0097226776151

Sponsors and Collaborators
Hadassah Medical Organization
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 Identifier: NCT00422370     History of Changes
Other Study ID Numbers: 38-29.12.06
Study First Received: December 14, 2006
Last Updated: January 16, 2007

Additional relevant MeSH terms:
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases processed this record on May 25, 2017