NCT00422370

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2006

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
Last Updated

January 17, 2007

Status Verified

December 1, 2006

First QC Date

December 14, 2006

Last Update Submit

January 16, 2007

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

  • Improvement in dry mouth symptom

Interventions

lipid based additives based on vegetable oil & lecithinDEVICE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dry mouth patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • 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 CHAIR

Central Study Contacts

Doron J Aframian, DMD PhD

CONTACT

0097226776151daframian@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2006

First Posted

January 17, 2007

Study Start

January 1, 2007

Last Updated

January 17, 2007

Record last verified: 2006-12