Clinical Trial of New Elastomer for Maxillofacial Prosthetics

NCT ID: NCT00123097

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2009-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: QUADRUPLE

Study Groups

Chlorinated polyethylene elastomer first

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

Group Type: EXPERIMENTAL

Chlorinated polyethylene elastomer

Intervention Type: COMBINATION_PRODUCT

Chlorinated polyethylene

Silicon first

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

Group Type: ACTIVE_COMPARATOR

Chlorinated polyethylene elastomer

Intervention Type: COMBINATION_PRODUCT

Chlorinated polyethylene

Interventions

Chlorinated polyethylene elastomer

Chlorinated polyethylene

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

CPE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Lawrence M. Gettleman, DMD, MSD

Professor, Gratis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sudarat Kiat-amnuay, DDS MS

Role: STUDY_CHAIR

University of Texas Dental Branch

Mark S Chambers, DMD MS

Role: STUDY_CHAIR

MD Anderson Cancer Center, Dept. of Head & Neck Surgery

James D Anderson, DDS MScD

Role: PRINCIPAL_INVESTIGATOR

Toronto Sunnybrook Regional Cancer Centre

Lawrence Gettleman, DMD, MSD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville, School of Dentistry

Locations

University of Louisville

Louisville, Kentucky, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20552094 (View on PubMed)

Other Identifiers

U01DE014543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5U01DE014543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDCR-14543

Identifier Type: -

Identifier Source: org_study_id

NCT00408486

Identifier Type: -

Identifier Source: nct_alias