Tongue NeoplasmsPGSRTNCT02584270
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue
A study testing Palatal Augmentation Prosthesis (PAP) and Articulation Therapy in people with Tongue Neoplasms and Tongue Cancer, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tongue Neoplasms, Tongue Cancer, Oral Cancer
- What is being tested?
- Palatal Augmentation Prosthesis (PAP) and Articulation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a new diagnosis of a T1/T2 tongue cancer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mary Burton contact
United States1 site, 1 recruiting
- Recruiting
University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry
Ann Arbor, Michigan, 48109
Stephanie Munz, DDS, 734-936-8289, smmunz@med.umich.edu
Mary Burton, mjburt@med.umich.edu
About this study
Official title: Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
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.
Read the 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
- Being tested
- Palatal Augmentation Prosthesis (PAP), Articulation Therapy
- Keywords
- palatal drop prosthesis
- Medical subject headings
- Tongue Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 TherapyOther
Also called Speech Therapy
Subjects will receive the standard of care speech and articulation therapy in either arm.
| Study group | Role | What they receive |
|---|---|---|
| Prosthesis + Articulation Therapy | Experimental | This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm Receives: Device: Palatal Augmentation Prosthesis (PAP); Other: Articulation Therapy |
| No Prosthesis; Articulation Therapy Only | Other | This arm will not receive a PAP (palatal augmentation prosthesis), but will receive standard articulation therapy. This is the control arm. Receives: Other: Articulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word intelligibility
The Assessment of Intelligibility of Dysarthric speech (AIDS) test is a validated assessment of word and sentence intelligibility as well as speech efficiency. The AIDS score will be measured at baseline before surgery for tongue cancer, then after surgery at the timepoints of one month, three months, six months and one year. Six months is the primary time point measurement. Measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured will be a percent score of words correctly transcribed by two blinded untrained listeners of the subjects' audio recordings of separate un-related words.
Measured: 6 months
Secondary outcomes (3)
Sentence intelligibility
The Assessment of intelligibility of dysarthric speech (AIDS) test is a validated assessment of word and sentence intelligibility as well as speech efficiency and will be measured at baseline before surgery for tongue cancer, then post-operatively at one month, three months, six months and one year. Six months is the primary time point measurement, although measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured will be a percent score of words correctly transcribed by two blinded untrained listeners of the subjects' audio recordings of words in sentences.
Measured: 6 months
Articulation at the word level of phonemes (consonant sounds)
The Goldman Fristoe 2 test of Articulation sounds in words subtest (GFTA2) is a standardized, validated and reliable tool that systematically assesses articulation of phonemes (consonant sounds). It offers normative data from ages 2 through 21. This will be measured at baseline pre-treatment of tongue cancer, then post-operatively at one month, three months, six months and one year. Six months is the primary time point measurement, although measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured is the raw score generated from the test.
Measured: 6 months
Patient satisfaction with speech
The Speech Handicap Index (SHI) is designed to evaluate an individual's speech function and corresponding psycho-social factors. This will be measured at baseline pre-treatment of tongue cancer, then post-operatively at one month, three months, six months and one year. Six months is the primary time point measurement, although measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured is the mean score of the survey.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start2 Jan 2018
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie M. Munz, University of Michigan
- Investigators
- Stephanie M Munz, DDS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584270
- Sponsor's protocol ID
- HUM00093723.1
- Acronym
- PGSRT
- Status last verified
- May 2026
- First submitted
- 20 Oct 2015
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02584270
- Acronym / sponsor ID
- PGSRT / HUM00093723.1
- Conditions
- Tongue Neoplasms, Tongue Cancer, Oral Cancer
- Keywords
- palatal drop prosthesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prosthesis + Articulation Therapy | Experimental | Device: Palatal Augmentation Prosthesis (PAP), Other: Articulation TherapyThis arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm |
| No Prosthesis; Articulation Therapy Only | Other | Other: Articulation TherapyThis arm will not receive a PAP (palatal augmentation prosthesis), but will receive standard articulation therapy. This is the control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a new diagnosis of a T1/T2 tongue cancer
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Prosthesis + Articulation Therapy |
| Articulation TherapyAlso: Speech TherapySubjects will receive the standard of care speech and articulation therapy in either arm. | Other | No Prosthesis; Articulation Therapy Only, Prosthesis + Articulation Therapy |
Primary outcome
Word intelligibility
Time frame: 6 months
The Assessment of Intelligibility of Dysarthric speech (AIDS) test is a validated assessment of word and sentence intelligibility as well as speech efficiency. The AIDS score will be measured at baseline before surgery for tongue cancer, then after surgery at the timepoints of one month, three months, six months and one year. Six months is the primary time point measurement. Measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured will be a percent score of words correctly transcribed by two blinded untrained listeners of the subjects' audio recordings of separate un-related words.
3 secondary outcomes
Sentence intelligibility
Time frame: 6 months
Articulation at the word level of phonemes (consonant sounds)
Time frame: 6 months
Patient satisfaction with speech
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Burton contact
Stephanie M Munz, DDS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatal Augmentation Prosthesis (PAP) and Articulation Therapy in people with Tongue Neoplasms and Tongue Cancer, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie M Munz, DDS (734 936-8289, smmunz@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word intelligibility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.