MedTrace Logo

Clinical Trial of New Elastomer for Maxillofacial Prosthetics

NCT00123097 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-04-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate a new rubber material used to make prosthetic replacements of the face lost to cancer, trauma, or birth defects.

Conditions

  • Facial Neoplasms
  • Head and Neck Neoplasms
  • Head Injuries, Penetrating
  • Birth Injuries

Interventions

COMBINATION_PRODUCT

Chlorinated polyethylene elastomer

Chlorinated polyethylene

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • University of Louisville

    lead OTHER

Principal Investigators

  • Sudarat Kiat-amnuay, DDS MS · University of Texas Dental Branch

  • Mark S Chambers, DMD MS · MD Anderson Cancer Center, Dept. of Head & Neck Surgery

  • James D Anderson, DDS MScD · Toronto Sunnybrook Regional Cancer Centre

  • Lawrence Gettleman, DMD, MSD · University of Louisville, School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00123097 on ClinicalTrials.gov