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Clinical Trial of New Elastomer for Maxillofacial Prosthetics

This study has been completed.
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Lawrence M. Gettleman, DMD, MSD, University of Louisville
ClinicalTrials.gov Identifier:
NCT00123097
First received: July 21, 2005
Last updated: April 5, 2017
Last verified: April 2017
July 21, 2005
April 5, 2017
February 2005
August 2009   (Final data collection date for primary outcome measure)
Non-inferiority of chlorinated polyethylene elastomer (CPE) material [ Time Frame: 10 month ]
  • 1. Non-inferiority of CPE material
  • 2. Non-inferiority of quality of life of CPE material
  • 3. Estimate of service life (longevity)
Complete list of historical versions of study NCT00123097 on ClinicalTrials.gov Archive Site
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Clinical Trial of New Elastomer for Maxillofacial Prosthetics
Multicenter Trial of CPE for Maxillofacial Prosthetics
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Device Feasibility
  • Facial Neoplasms
  • Head and Neck Neoplasms
  • Head Injuries, Penetrating
  • Birth Injuries
Combination Product: Chlorinated polyethylene elastomer
Chlorinated polyethylene
Other Name: CPE
  • Experimental: Chlorinated polyethylene elastomer first
    Patient receives prosthetic made from CPE then the SOC, silicon.
    Intervention: Combination Product: Chlorinated polyethylene elastomer
  • Active Comparator: Silicon first
    Patient receives prosthetic made from the SOC, silicon, followed by the CPE,Chlorinated polyethylene elastomer.
    Intervention: Combination Product: Chlorinated polyethylene elastomer
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
August 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00123097
NIDCR-14543
U01DE014543 ( US NIH Grant/Contract Award Number )
5U01DE014543 ( US NIH Grant/Contract Award Number )
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Lawrence M. Gettleman, DMD, MSD, University of Louisville
University of Louisville
National Institute of Dental and Craniofacial Research (NIDCR)
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
University of Louisville
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP