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Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
ClinicalTrials.gov Identifier: | NCT00123097 |
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.
Condition | Intervention | Phase |
---|---|---|
Facial Neoplasms Head and Neck Neoplasms Head Injuries, Penetrating Birth Injuries |
Device: Chlorinated polyethylene elastomer |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Multicenter Trial of CPE for Maxillofacial Prosthetics |
Estimated Enrollment: | 100 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Maxillofacial prosthetics is a subspecialty of prosthodontics, providing the clinical rehabilitation treatment of patients who have lost parts of the face due to cancer, trauma, or birth defects. It is an orphan field that:
Silicone rubber materials have been used for facial rehabilitation for more than 4 decades with few improvements.
There is a clear need for new, alternative, and more economic materials for extraoral maxillofacial prostheses.
Research at Gulf South Research Institute in New Orleans by the Principal Investigator and others in the 1970s and 1980s developed an alternative low-cost thermoplastic industrial rubber material (chlorinated polyethylene, CPE) that met all toxicological (safety) and physical (effectiveness) requirements. A Phase 2 clinical trial at the time yielded equivocal results when compared to conventional but costly silicone rubber products.
This research is a controlled, randomized, single-crossover, double-blinded investigator-initiated multicenter
Phase 3 clinical trial treating 100 patients that evaluates:
The clinical centers of the trial are at M.D. Anderson Cancer Center in Houston, Texas, and at the Toronto Sunnybrook Regional Cancer Centre in Toronto, Canada.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Kentucky | |
University of Louisville | |
Louisville,, Kentucky, United States, 40292-0001 |
Study Chair: | Sudarat Kiat-amnuay, DDS MS | University of Texas Dental Branch |
Study Chair: | Mark S Chambers, DMD MS | MD Anderson Cancer Center, Dept. of Head & Neck Surgery |
Principal Investigator: | James D Anderson, DDS MScD | Toronto Sunnybrook Regional Cancer Centre |
Principal Investigator: | Lawrence Gettleman, DMD, MSD | University of Louisville, School of Dentistry |
Responsible Party: | University of Louisville ( Lawrence Gettleman, DMD, MSD ) |
Study ID Numbers: | NIDCR-14543, 5U01 DE-014543 |
Study First Received: | July 21, 2005 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00123097 History of Changes |
Health Authority: | United States: Federal Government |
Facial Neoplasms Head and Neck Neoplasms Head Injuries, Penetrating Birth Injuries |
Craniocerebral Trauma Wounds, Penetrating Facies Head Injuries, Penetrating Birth Injuries Head and Neck Neoplasms |
Wounds and Injuries Facial Neoplasms Disorders of Environmental Origin Infant, Newborn, Diseases Trauma, Nervous System |
Craniocerebral Trauma Head Injuries, Penetrating Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin Trauma, Nervous System Neoplasms |
Wounds, Penetrating Neoplasms by Site Birth Injuries Head and Neck Neoplasms Facial Neoplasms Infant, Newborn, Diseases |