Clinical Trial of New Elastomer for Maxillofacial Prosthetics

April 5, 2017 updated by: Lawrence M. Gettleman, DMD, MSD, University of Louisville

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chlorinated polyethylene elastomer first
Patient receives prosthetic made from CPE then the SOC, silicon.
Combination product: Chlorinated polyethylene elastomer
Chlorinated polyethylene
Other Names:
  • 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 Names:
  • CPE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-inferiority of chlorinated polyethylene elastomer (CPE) material
Time Frame: 10 month
10 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 21, 2005

First Submitted That Met QC Criteria

July 21, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDCR-14543
  • U01DE014543 (U.S. NIH Grant/Contract)
  • 5U01DE014543 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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