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Efficacy of Implant-Supported Maxillofacial Prostheses


Phase 2
35 Years
80 Years
Open (Enrolling)
Both
Head and Neck Cancer, Oral Complications

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Trial Information

Efficacy of Implant-Supported Maxillofacial Prostheses


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Neal R. Garrett, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066588

NCT ID:

NCT00006341

Start Date:

June 1997

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Oral Complications
  • stage I lip and oral cavity cancer
  • stage II lip and oral cavity cancer
  • stage III lip and oral cavity cancer
  • oral complications
  • Head and Neck Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781