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Recruiting NCT02584270

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

Trial Parameters

Condition Tongue Neoplasms
Sponsor University of Michigan
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2018-01-02
Completion 2026-01
Interventions
Palatal Augmentation Prosthesis (PAP)Articulation Therapy

Brief 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 Criteria

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

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