Clinical trial NCT00123097: Clinical Trial of New Elastomer for Maxillofacial Prosthetics
Official title: Multicenter Trial of CPE for Maxillofacial Prosthetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Neoplasms
Head and Neck Neoplasms
Head Injuries, Penetrating
Birth Injuries
Keywords: Facial Neoplasms
Head and Neck Neoplasms
Head Injuries, Penetrating
Birth Injuries
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2005-07-22
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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 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 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

Primary outcomes:
measure: Non-inferiority of chlorinated polyethylene elastomer (CPE) material
timeFrame: 10 month
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville,
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Texas Dental Branch
name: Sudarat Kiat-amnuay, DDS MS
role: STUDY_CHAIR
affiliation: MD Anderson Cancer Center, Dept. of Head & Neck Surgery
name: Mark S Chambers, DMD MS
role: STUDY_CHAIR
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: James D Anderson, DDS MScD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville, School of Dentistry
name: Lawrence Gettleman, DMD, MSD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiat-amnuay S, Jacob RF, Chambers MS, Anderson JD, Sheppard RA, Johnston DA, Haugh GS, Gettleman L. Clinical trial of chlorinated polyethylene for facial prosthetics. Int J Prosthodont. 2010 May-Jun;23(3):263-70.