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Clinical Trial of New Elastomer for Maxillofacial Prosthetics

This study is currently recruiting patients

Verified by National Institute of Dental and Craniofacial Research (NIDCR) September 2006

Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00123097


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
Device: Chlorinated polyethylene elastomer Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title: Multicenter Trial of CPE for Maxillofacial Prosthetics

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):
Primary Outcomes: Non-inferiority of chlorinated polyethylene elastomer (CPE) material; Non-inferiority of quality of life of CPE material; Estimate of service life (longevity)
Expected Total Enrollment:  100

Study start: February 2005;  Expected completion: May 2008
Last follow-up: July 2005;  Data entry closure: May 2008

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 above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00123097


Kentucky
University of Louisville, Louisville,,  Kentucky,  40292-0001,  United States; Recruiting
Lawrence Gettleman, DMD, MSD  502-852-1185    gettleman@louisville.edu 
Lale Akca, BA
Lawrence Gettleman, DMD, MSD,  Principal Investigator

Study chairs or principal investigators

Sudarat Kiat-amnuay, DDS MS,  Study Chair,  University of Texas Dental Branch   
Mark S Chambers, DMD MS,  Study Chair,  MD Anderson Cancer Center, Dept. of Head & Neck Surgery   
James D Anderson, DDS MScD,  Principal Investigator,  Toronto Sunnybrook Regional Cancer Centre   
Lawrence Gettleman, DMD, MSD,  Principal Investigator,  University of Louisville, School of Dentistry   

More Information

Study ID Numbers:  NIDCR-14543; 5U01 DE-014543
Last Updated:  September 14, 2006
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00123097
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-09-29





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