Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00006341


Primary Contact:

Study Chair
Neal R. Garrett, PhD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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