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

NCT00006341 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2016-02-02

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Implant

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.

Sponsors & Collaborators

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Neal R. Garrett, PhD · Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-06-30
Primary Completion
2003-05-31
Completion
2003-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006341 on ClinicalTrials.gov