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| ID | Type | Description | Link |
|---|---|---|---|
| UCLA-HSPC-940205413 | |||
| UCLA-DEN-1R01DE11255 | |||
| UCLA-HSPC-940205411 | |||
| NCI-V00-1606 |
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RATIONALE: The use of dentures and dental implants may help maintain chewing and speaking ability following surgery to remove tumors in the mouth.
PURPOSE: Phase II trial to study the effectiveness of dentures and dental implants in maintaining the ability to chew and speak in patients undergoing surgery for mouth cancer.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant | Experimental | A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled. The mandibular defects will be reconstructed with fibula free flap surgery. Following a healing period, implants will be placed and permitted to heal unloaded for six months. Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded. A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant | Other | A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled. The mandibular defects will be reconstructed with fibula free flap surgery. Following a healing period, implants will be placed and permitted to heal unloaded for six months. Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded. A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses. |
DISEASE CHARACTERISTICS:
Diagnosis of early oral cancer lesions requiring one of the following:
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Neal R. Garrett, PhD | Jonsson Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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