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Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006341
First received: October 4, 2000
Last updated: August 19, 2009
Last verified: December 2002
History of Changes
  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
Head and Neck Cancer
Oral Complications
 Procedure: conventional surgery
Procedure: management of therapy complications
Procedure: quality-of-life assessment
Radiation: radiation therapy
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

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

ClinicalTrials.gov Identifier: NCT00006341     History of Changes
Other Study ID Numbers: CDR0000066588, UCLA-HSPC-940205413, UCLA-DEN-1R01DE11255, UCLA-HSPC-940205411, NCI-V00-1606
Study First Received: October 4, 2000
Last Updated: August 19, 2009
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013