Efficacy of Implant-Supported Maxillofacial Prostheses
- Determine whether conventional or implant supported dental prostheses and current
surgical reconstructive procedures restore oral function and quality of life to
pre-cancer surgery levels in patients with early oral cancer.
OUTLINE: Patients complete a series of objective and subjective functional tests,
questionnaires, and baseline examinations. Within 1-5 days, patients undergo the composite
resection, including reconstructive surgery for the mandibulectomy group. Patients in the
maxillectomy group receive an immediate maxillary surgical obturator. Approximately 6 weeks
after ablative surgery, some patients receive radiotherapy for 5-7 weeks.
Patients receive 2-4 implants at 12-16 weeks after completion of radiotherapy or 8-16 weeks
after ablative surgery. Patients then receive conventional dentures at 4-22 weeks after
implant surgery. Implants are exposed during 27-48 weeks after placement and abutments
connected for fabricating dental prostheses. Approximately 8 weeks are needed to fabricate
the implant supported prosthesis.
Patients complete quality of life and other questionnaires prior to and at 8-21 weeks after
surgery, 16 weeks after conventional denture insertion, and then 16 weeks after implant
supported prosthesis insertion.
Patients are followed every 6 months for at least 3 years.
PROJECTED ACCRUAL: A total of 62 patients (22 requiring maxillectomy and 40 requiring
mandibulectomy) will be accrued for this study within 42 months.
Primary Purpose: Supportive Care
Neal R. Garrett, PhD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|