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NCT02584270NARecruiting

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

University of Michigan

Start Date

1/2/2018

Completion Date

6/1/2028

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.

Detailed Description

This study will randomize patients into two arms; one for oral cancer patients that receive a small device, similar to a denture, called a PAP. The other arm will be patients who serve as a control and will not receive a PAP. The PAP requires patients to have a dental mold created. A dentist customizes the PAP to specifically fit the individual's mouth. The study will investigate whether the PAP improves speech following tongue cancer as measured by three different scales. Both groups will see a speech language therapist for additional measures of speech evaluation.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patients with a new diagnosis of a T1/T2 tongue cancer Exclusion Criteria: * Patients with recurrent disease * Patients with a history of prior head and neck radiation therapy * Patients who lack adequate maxillary dentition to support a palatal augmentation prosthesis

Interventions

DEVICE

Palatal Augmentation Prosthesis (PAP)

OTHER

Articulation Therapy

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Conditions

Tongue NeoplasmsTongue CancerOral Cancer

Locations

University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry

Ann Arbor, Michigan 48109

United States