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Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer Clinical research trials and Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer. Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer  Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
For Condition: oral complications of cancer and cancer therapy,stage 3 lip and oral cavity cancer,Quality of Life,stage 1 lip and oral cavity cancer,stage 2 lip and oral cavity cancer
Status: No longer recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center ,
Synopsis: 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.
Details: OBJECTIVES: I. 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. PROTOCOL 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:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 35 Years/80 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NealGarrett, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000066588; UCLA-HSPC-940205413,UCLA-HSPC-940205411,NCI-V00-1606,UCLA-DEN-1R01DE11255
Study Start Date: June 1997
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006341
Other Stage 1 Lip And Oral Cavity Cancer Studies:
1. Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
Related Studies:
Other stage 1 lip and oral cavity cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
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