NCT00006341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jun 1997

Typical duration for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 29, 2003

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

5.9 years

First QC Date

October 4, 2000

Last Update Submit

January 29, 2016

Conditions

Head and Neck Cancer

Keywords

stage I lip and oral cavity cancerstage II lip and oral cavity cancerstage III lip and oral cavity cancer

Study Arms (1)

Implant

EXPERIMENTAL

A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled. The mandibular defects will be reconstructed with fibula free flap surgery. Following a healing period, implants will be placed and permitted to heal unloaded for six months. Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded. A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses.

Other: Implant

Interventions

ImplantOTHER

A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled. The mandibular defects will be reconstructed with fibula free flap surgery. Following a healing period, implants will be placed and permitted to heal unloaded for six months. Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded. A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses.

Implant

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsMouth Neoplasms

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • Neal R. Garrett, PhD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2000

First Posted

May 29, 2003

Study Start

June 1, 1997

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

February 2, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)