Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer - Full Text View

Sponsored by:	Jonsson Comprehensive Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006341

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.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Head and Neck Cancer	Procedure: conventional surgery Procedure: management of therapy complications Procedure: quality-of-life assessment Radiation: radiation therapy	Phase II

MedlinePlus related topics: Cancer Dentures Head and Neck Cancer Oral Cancer Radiation Therapy Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care
Official Title:	Efficacy of Implant-Supported Maxillofacial Prostheses

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	62
Study Start Date:	June 1997

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.

Eligibility

Ages Eligible for Study:	35 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006341

Locations

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

Investigators

Study Chair:

Neal R. Garrett, PhD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066588, UCLA-HSPC-940205413, UCLA-DEN-1R01DE11255, UCLA-HSPC-940205411, NCI-V00-1606
Study First Received:	October 4, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00006341 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I lip and oral cavity cancer
stage II lip and oral cavity cancer
stage III lip and oral cavity cancer
oral complications
quality of life

Study placed in the following topic categories:

Lip and Oral Cavity Cancer
Head and Neck Neoplasms
Quality of Life
Mouth Neoplasms
Oral Cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009