Efficacy of Implant-Supported Maxillofacial Prostheses
35 Years
80 Years
Both
Head and Neck Cancer, Oral Complications
Trial Information
Efficacy of Implant-Supported Maxillofacial Prostheses
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of early oral cancer lesions requiring one of the following:
- Partial or total unilateral maxillectomy OR
- Partial lateral mandibulectomy with or without partial glossectomy
- Edentulous or edentulous in the maxillary arch prior to or after ablative surgery
(maxillectomy group)
- Partial mandibulectomy leaving the condyles intact bilaterally (mandibulectomy group)
- Must have sufficient bone in the selected implant sites to accommodate 2-4 implants
of at least 10 mm in length
- No temporomandibular dysfunction and/or functionally restrictive opening
- No requirement for total glossectomy, reconstructive maxillary surgery, or maxillary
sinus lift
- No requirement for radiotherapy after mandibular reconstructive surgery
PATIENT CHARACTERISTICS:
Age:
- 35 to 80
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No oral discomfort that would preclude study
- No complications after ablative or reconstructive surgery that would preclude dental
rehabilitation with implants
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior or concurrent radiotherapy of greater than 5,500 cGY to potential implant
site
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
Neal R. Garrett, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066588
NCT ID:
NCT00006341
Start Date:
June 1997
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Oral Complications
- stage I lip and oral cavity cancer
- stage II lip and oral cavity cancer
- stage III lip and oral cavity cancer
- oral complications
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
