Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will fill a scientific gap in the current knowledge providing data for evaluation of the palatal augmentation prosthesis (PAP) as a therapeutic modality post-surgery. This is a robust scientific randomized prospective clinical trial. Positive outcomes from this study have the potential to dramatically alter the most common issues of oral cancer therapy, namely speech and swallowing functions. Patients will have been diagnosed with a cancer lesion of the tongue requiring surgery and removal of part of the tongue. Smaller cancers of the tongue are sized as T1 or T2. For patients with smaller lesions, a PAP, which can aid in speaking and swallowing, is not routinely provided.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with a new diagnosis of a T1/T2 tongue cancer

Locations
United States
Michigan
University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry
RECRUITING
Ann Arbor
Contact Information
Primary
Stephanie M Munz, DDS
smmunz@med.umich.edu
734 936-8289
Backup
Mary Burton
mjburt@med.umich.edu
Time Frame
Start Date: 2018-01-02
Estimated Completion Date: 2026-06
Participants
Target number of participants: 40
Treatments
Experimental: Prosthesis + Articulation Therapy
This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm
Other: No Prosthesis; Articulation Therapy Only
This arm will not receive a PAP (palatal augmentation prosthesis), but will receive standard articulation therapy. This is the control arm.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov