Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123097
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2005-07-21
Brief Title:
Clinical Trial of New Elastomer for Maxillofacial Prosthetics
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Multicenter Trial of CPE for Maxillofacial Prosthetics
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
treats few patients making the subspecialty unprofitable for manufacturers to develop new materials
offers fundamental rehabilitation and improvement in the quality of life to patients who may have exhausted personal or third party funding and
provides a dental solution to an essentially medical problem
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
experimental thermoplastic CPE and
control silicone Silastic Adhesive AMDX4-4210 materials for non-inferiority of CPE based on functional and subjective characteristics and on the quality of life
The clinical centers of the trial are at MD Anderson Cancer Center in Houston Texas and at the Toronto Sunnybrook Regional Cancer Centre in Toronto Canada
treats few patients making the subspecialty unprofitable for manufacturers to develop new materials
offers fundamental rehabilitation and improvement in the quality of life to patients who may have exhausted personal or third party funding and
provides a dental solution to an essentially medical problem
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
experimental thermoplastic CPE and
control silicone Silastic Adhesive AMDX4-4210 materials for non-inferiority of CPE based on functional and subjective characteristics and on the quality of life
The clinical centers of the trial are at MD Anderson Cancer Center in Houston Texas and at the Toronto Sunnybrook Regional Cancer Centre in Toronto Canada
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01DE014543 | NIH | None | httpsreporternihgovquickSearch5U01DE014543 |
| U01DE014543 | NIH | None | None |