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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
  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 Combination Product: Chlorinated polyethylene elastomer Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Device Feasibility
Official Title: Multicenter Trial of CPE for Maxillofacial Prosthetics

Resource links provided by NLM:


Further study details as provided by Lawrence M. Gettleman, DMD, MSD, University of Louisville:

Primary Outcome Measures:
  • Non-inferiority of chlorinated polyethylene elastomer (CPE) material [ Time Frame: 10 month ]

Enrollment: 42
Study Start Date: February 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chlorinated polyethylene elastomer first
Patient receives prosthetic made from CPE then the SOC, silicon.
Combination Product: Chlorinated polyethylene elastomer
Chlorinated polyethylene
Other Name: CPE
Active Comparator: Silicon first
Patient receives prosthetic made from the SOC, silicon, followed by the CPE,Chlorinated polyethylene elastomer.
Combination Product: Chlorinated polyethylene elastomer
Chlorinated polyethylene
Other Name: CPE

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Louisville
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lawrence M. Gettleman, DMD, MSD, Professor, Gratis, University of Louisville
ClinicalTrials.gov Identifier: NCT00123097     History of Changes
Obsolete Identifiers: NCT00408486
Other Study ID Numbers: NIDCR-14543
U01DE014543 ( U.S. NIH Grant/Contract )
5U01DE014543 ( U.S. NIH Grant/Contract )
Study First Received: July 21, 2005
Last Updated: April 5, 2017

Keywords provided by Lawrence M. Gettleman, DMD, MSD, University of Louisville:
Facial Neoplasms
Head and Neck Neoplasms
Head Injuries, Penetrating
Birth Injuries

Additional relevant MeSH terms:
Wounds and Injuries
Neoplasms
Head and Neck Neoplasms
Craniocerebral Trauma
Birth Injuries
Facial Neoplasms
Head Injuries, Penetrating
Neoplasms by Site
Trauma, Nervous System
Nervous System Diseases
Infant, Newborn, Diseases
Wounds, Penetrating
Silicon
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017