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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00422370
Other study ID # 38-29.12.06
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 14, 2006
Last updated January 16, 2007
Start date January 2007

Study information

Verified date December 2006
Source Hadassah Medical Organization
Contact Doron J Aframian, DMD PhD
Phone 0097226776151
Email daframian@yahoo.com
Is FDA regulated No
Health authority Israel: Health Department
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Dry mouth patients

Exclusion Criteria:

- Disabled patients

- Pregnant

- Full upper denture

- Under 18 years old

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind


Related Conditions & MeSH terms


Intervention

Device:
lipid based additives based on vegetable oil & lecithin


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in dry mouth symptom
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