Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Tongue Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorUniversity of Michigan
Academic / other
Drugs / interventionsradiation
Locations1 site (Ann Arbor, Michigan)
StatusRecruiting
StartedJanuary 2, 2018
Main results expectedJanuary 2028
Study endsJune 2028
Registry record updatedMay 8, 2026
Trial IDNCT02584270 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.