Lipid Based Food Additives for Treating Patients With Dry Mouth

January 16, 2007 updated by: Hadassah Medical Organization
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dry mouth patients

Exclusion Criteria:

  • Disabled patients
  • Pregnant
  • Full upper denture
  • Under 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement in dry mouth symptom

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Registration Dates

First Submitted

December 14, 2006

First Submitted That Met QC Criteria

January 16, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

January 17, 2007

Last Update Submitted That Met QC Criteria

January 16, 2007

Last Verified

December 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38-29.12.06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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