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Clinical Trial of New Elastomer for Maxillofacial Prosthetics

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Chlorinated polyethylene elastomer
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Facial Neoplasms focused on measuring Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating, Birth Injuries

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chlorinated polyethylene elastomer first

Silicon first

Arm Description

Patient receives prosthetic made from CPE then the SOC, silicon.

Patient receives prosthetic made from the SOC, silicon, followed by the CPE,Chlorinated polyethylene elastomer.

Outcomes

Primary Outcome Measures

Non-inferiority of chlorinated polyethylene elastomer (CPE) material

Secondary Outcome Measures

Full Information

First Posted
July 21, 2005
Last Updated
April 5, 2017
Sponsor
University of Louisville
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT00123097
Brief Title
Clinical Trial of New Elastomer for Maxillofacial Prosthetics
Official Title
Multicenter Trial of CPE for Maxillofacial Prosthetics
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating, Birth Injuries
Keywords
Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating, Birth Injuries

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorinated polyethylene elastomer first
Arm Type
Experimental
Arm Description
Patient receives prosthetic made from CPE then the SOC, silicon.
Arm Title
Silicon first
Arm Type
Active Comparator
Arm Description
Patient receives prosthetic made from the SOC, silicon, followed by the CPE,Chlorinated polyethylene elastomer.
Intervention Type
Combination Product
Intervention Name(s)
Chlorinated polyethylene elastomer
Other Intervention Name(s)
CPE
Intervention Description
Chlorinated polyethylene
Primary Outcome Measure Information:
Title
Non-inferiority of chlorinated polyethylene elastomer (CPE) material
Time Frame
10 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudarat Kiat-amnuay, DDS MS
Organizational Affiliation
University of Texas Dental Branch
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark S Chambers, DMD MS
Organizational Affiliation
MD Anderson Cancer Center, Dept. of Head & Neck Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James D Anderson, DDS MScD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence Gettleman, DMD, MSD
Organizational Affiliation
University of Louisville, School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville,
State/Province
Kentucky
ZIP/Postal Code
40292-0001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20552094
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.
Results Reference
derived

Learn more about this trial

Clinical Trial of New Elastomer for Maxillofacial Prosthetics

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