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

NCT ID: NCT02584270

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2026-06-30

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.

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.

Conditions

Tongue Neoplasms; Tongue Cancer; Oral Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prosthesis + Articulation Therapy

This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm

Group Type: EXPERIMENTAL

Palatal Augmentation Prosthesis (PAP)

Intervention Type: DEVICE

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.

Articulation Therapy

Intervention Type: OTHER

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

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.

Group Type: OTHER

Articulation Therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Articulation Therapy

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

Intervention Type: OTHER

Other Intervention Names

Speech Therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Stephanie M. Munz

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie M Munz, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephanie M Munz, DDS

Role: CONTACT

smmunz@med.umich.edu

734 936-8289

Mary Burton

Role: CONTACT

mjburt@med.umich.edu

Facility Contacts

Stephanie Munz, DDS

Role: primary

smmunz@med.umich.edu

734-936-8289

Mary Burton

Role: backup

mjburt@med.umich.edu

Other Identifiers

HUM00093723.1

Identifier Type: -

Identifier Source: org_study_id