Rehabilitation for speech after tongue cancer surgery using a prosthesis
Official title: Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
Run by University of Michigan · NCT02584270 · Data updated 2026-11-12
This study is testing if a special mouthpiece can help people who had tongue cancer surgery speak and swallow better compared to those who don’t use it.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | January 2, 2018 |
| Main results expected | January 2028 |
| Study ends | June 2028 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT02584270 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients newly diagnosed with T1/T2 tongue cancer requiring surgical intervention.
✕Probably not a fit
Patients with recurrent disease, prior head and neck radiation therapy, or inadequate dental support for the prosthesis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a palatal augmentation prosthesis (PAP) in improving speech and swallowing functions in patients who have undergone surgery for T1/T2 tongue cancer. Patients will be randomly assigned to receive either the PAP or serve as a control group without the device. The study aims to fill a gap in current knowledge regarding post-surgical rehabilitation for oral cancer patients. Speech evaluations will be conducted using multiple scales to assess the impact of the PAP on communication abilities.
Why it matters
Potential benefit: If successful, this approach could significantly enhance speech and swallowing functions for patients recovering from tongue cancer surgery.
How similar studies have gone: While the use of prostheses in oral rehabilitation is established, this specific approach with the PAP is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Principal investigator: Stephanie M Munz, DDS — University of Michigan
- Study coordinator: Stephanie M Munz, DDS
- Email: smmunz@med.umich.edu
- Phone: 734 936-8289
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.