This trial is active, not recruiting.

Conditions head and neck cancer, oral complications
Treatments conventional surgery, management of therapy complications, quality-of-life assessment, radiation therapy
Phase phase 2
Sponsor Jonsson Comprehensive Cancer Center
Start date June 1997
Trial size 62 participants
Trial identifier NCT00006341, CDR0000066588, NCI-V00-1606, UCLA-DEN-1R01DE11255, UCLA-HSPC-940205411, UCLA-HSPC-940205413


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose supportive care

Eligibility Criteria

Male or female participants from 35 years up to 80 years old.

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

Additional Information

Official title Efficacy of Implant-Supported Maxillofacial Prostheses
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).