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Status:

COMPLETED

Clinical Trial of New Elastomer for Maxillofacial Prosthetics

Lead Sponsor:

University of Louisville

Collaborating Sponsors:

National Institute of Dental and Craniofacial Research (NIDCR)

Conditions:

Facial Neoplasms

Head and Neck Neoplasms

Eligibility:

All Genders

21+ years

Phase:

PHASE3

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 i...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2009

    Estimated Enrollment :

    42 Patients enrolled

    Trial Details

    Trial ID

    NCT00123097

    Start Date

    February 1 2005

    End Date

    August 1 2009

    Last Update

    April 7 2017

    Active Locations (1)

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    1

    University of Louisville

    Louisville, Kentucky, United States, 40292-0001