Lipid Based Food Additives for Treating Patients With Dry Mouth

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT00422370
Collaborator
(none)
20

Study Details

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 Phase
  • Device: lipid based additives based on vegetable oil & lecithin
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Improvement in dry mouth symptom []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00422370
Other Study ID Numbers:
  • 38-29.12.06
First Posted:
Jan 17, 2007
Last Update Posted:
Jan 17, 2007
Last Verified:
Dec 1, 2006
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 17, 2007