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| Descriptive Information Fields | |||||||||||||||||
| Brief Title † | Clinical Trial of New Elastomer for Maxillofacial Prosthetics | ||||||||||||||||
| Official Title † | Multicenter Trial of CPE for Maxillofacial Prosthetics | ||||||||||||||||
| Brief 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||||||||||||||
| Study Type † | Interventional | ||||||||||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study | ||||||||||||||||
| Primary Outcome Measure † | Non-inferiority of chlorinated polyethylene elastomer (CPE) material [ Time Frame: 10 month ] [ Designated as safety issue: No ] | ||||||||||||||||
| Secondary Outcome Measure † | |||||||||||||||||
| Condition † | Facial Neoplasms Head and Neck Neoplasms Head Injuries, Penetrating Birth Injuries |
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| Intervention † | Device: Chlorinated polyethylene elastomer | ||||||||||||||||
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| Recruitment Information Fields | |||||||||||||||||
| Recruitment Status † | Active, not recruiting | ||||||||||||||||
| Enrollment † | 100 | ||||||||||||||||
| Start Date † | February 2005 | ||||||||||||||||
| Completion Date | August 2008 | ||||||||||||||||
| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 21 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts †† | |||||||||||||||||
| Location Countries † | United States | ||||||||||||||||
| Administrative Information Fields | |||||||||||||||||
| NCT ID † | NCT00123097 | ||||||||||||||||
| Organization ID | NIDCR-14543 | ||||||||||||||||
| Secondary IDs †† | 5U01 DE-014543 | ||||||||||||||||
| Study Sponsor † | National Institute of Dental and Craniofacial Research (NIDCR) | ||||||||||||||||
| Collaborators †† | |||||||||||||||||
| Investigators † |
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| Information Provided By | National Institute of Dental and Craniofacial Research (NIDCR) | ||||||||||||||||
| Verification Date | July 2008 | ||||||||||||||||
| First Received Date † | July 21, 2005 | ||||||||||||||||
| Last Updated Date | July 16, 2008 | ||||||||||||||||