MedTrace Logo

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue

NCT02584270 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Tongue Neoplasms
  • Tongue Cancer
  • Oral Cancer

Interventions

DEVICE

Palatal Augmentation Prosthesis (PAP)

The palatal augmentation prosthesis, or PAP can improve speech and swallowing functions through reshaping the palatal contours. This may improve the contact between the tongue and hard palate as a person speaks or eats. It is meant to be created after adequate healing in patients with adequate motivation for improvements in their speech and swallowing. Regular wear and articulation therapy are necessary for this therapy to be effective.

OTHER

Articulation Therapy

Subjects will receive the standard of care speech and articulation therapy in either arm.

Sponsors & Collaborators

Principal Investigators

  • Stephanie M Munz, DDS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2028-01-31
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02584270 on ClinicalTrials.gov