dentures and dental implants in treating patients undergoing surgery for mouth cancer

Conditions: Head and Neck Cancer

Summary: 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: * 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.

Eligibility 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

Keywords: stage i lip and oral cavity cancer stage ii lip and oral cavity cancer stage iii lip and oral cavity cancer