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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT02584270
Status
Recruiting
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Conditions

  • Oral Cancer
  • Tongue Cancer
  • Tongue Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palatal Augmentation Prosthesis (PAP) — 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 — OTHER
    Subjects will receive the standard of care speech and articulation therapy in either arm.

Study Details

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.

Key Dates

Start date
Jan 2, 2018
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Word intelligibility [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Department of Oral and Maxillofacial Surgery and Hospital DentistryAnn ArborMichigan48109
Stephanie Munz, DDS
[email protected]
734-936-8289
Mary Burton
[email protected]

Find similar trials in Ann Arbor, MI

By research site
University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry· Ann Arbor, MI

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