Recruiting

Speech Rehabilitation

Sponsor:

University of Michigan

Code:

NCT02584270

Conditions

Tongue Neoplasms

Tongue Cancer

Oral Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Palatal Augmentation Prosthesis (PAP)

Articulation Therapy

Study Details

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.

Conditions

Tongue Neoplasms

Tongue Cancer

Oral Cancer

Study ID

NCT02584270

Start date

Jan 2, 2018

Status verified date

May, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Articulation Therapy

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

Primary outcome measure

  • Word intelligibility [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Stephanie M Munz, DDS

734 936-8289smmunz@med.umich.edu

Mary Burton

mjburt@med.umich.edu

Locations

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

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Stephanie Munz, DDS

734-936-8289smmunz@med.umich.edu

Mary Burton

mjburt@med.umich.edu

More Information

Sponsor

University of Michigan

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • palatal drop prosthesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-05-08.