Clinical Trial of New Elastomer for Maxillofacial Prosthetics - Full Text View

Sponsored by:	National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:	National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier:	NCT00123097

Purpose

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

MedlinePlus related topics: Cancer Head and Neck Cancer Injuries Traumatic Brain Injury Wounds

U.S. FDA Resources

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

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:

Non-inferiority of chlorinated polyethylene elastomer (CPE) material [ Time Frame: 10 month ] [ Designated as safety issue: No ]

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)

Intervention Details:

Chlorinated polyethylene

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 A/MDX4-4210) 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 M.D. Anderson Cancer Center in Houston, Texas, and at the Toronto Sunnybrook Regional Cancer Centre in Toronto, Canada.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Requires treatment for developmental or acquired extraoral facial defect
Fully healed wound (6 months after surgery and/or radiation)
Defect no larger than 9 x 12 cm (3.5 x 4.5 inches, the diameter of a giant bronze flask)
Cognizant enough to answer questionnaires
Agrees to wear the prosthesis at least 6 hours per day
Agrees to use the prescribed adhesive (Epithane-3 - now called Daro Adhesive Extra Strength) and clean and store as instructed
Plans to be able to return to the research institution for a 10 month period
Able to manage prosthesis him/herself or with caregiver for a 10 month period
Karnofsky score greater than or equal to 60 (www.hospicepatients.org/karnofsky.html)
No framework or implant/magnet retention
No multiple recurrences of tumor
No hypersensitivity to adhesives or test materials
No current systemic or topical facial steroid treatment
Not legally blind
Not expected to have further surgeries to defect, radiation therapy, or other cytoreductive therapy over the next 10 months
No evidence of active skin condition/disease
Not an infectious risk patient

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123097

Locations

United States, Kentucky
University of Louisville
Louisville,, Kentucky, United States, 40292-0001

Sponsors and Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

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

More Information

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
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009