Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer

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.

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