- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006341
Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
Efficacy of Implant-Supported Maxillofacial Prostheses
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 Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Implant
A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled.
The mandibular defects will be reconstructed with fibula free flap surgery.
Following a healing period, implants will be placed and permitted to heal unloaded for six months.
Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded.
A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses.
|
A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled.
The mandibular defects will be reconstructed with fibula free flap surgery.
Following a healing period, implants will be placed and permitted to heal unloaded for six months.
Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded.
A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses.
|
Collaborators and Investigators
Investigators
- Study Chair: Neal R. Garrett, PhD, Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066588
- UCLA-HSPC-940205413
- UCLA-DEN-1R01DE11255
- UCLA-HSPC-940205411
- NCI-V00-1606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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