Clinical trial NCT00006341: Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
Official title: Efficacy of Implant-Supported Maxillofacial Prostheses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: stage I lip and oral cavity cancer
stage II lip and oral cavity cancer
stage III lip and oral cavity cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2003-05-29
Enrollment: 46
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Neal R. Garrett, PhD
role: STUDY_CHAIR
References: