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Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
This study is ongoing, but not recruiting participants.
Study NCT00006341   Information provided by National Cancer Institute (NCI)
First Received: October 4, 2000   Last Updated: May 9, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

October 4, 2000
May 9, 2009
June 1997
 
 
Complete list of historical versions of study NCT00006341 on ClinicalTrials.gov Archive Site
 
 
 
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.

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.

Phase II
Interventional
Supportive Care
  • Head and Neck Cancer
  • Oral Complications
  • Quality of Life
  • Procedure: conventional surgery
  • Procedure: management of therapy complications
  • Procedure: quality-of-life assessment
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
62
 
 

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
Both
35 Years to 80 Years
No
 
United States
 
 
NCT00006341
 
UCLA-HSPC-940205413, UCLA-DEN-1R01DE11255, UCLA-HSPC-940205411, NCI-V00-1606
Jonsson Comprehensive Cancer Center
 
Study Chair: Neal R. Garrett, PhD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2002

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.