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Prosthesis

Speech Rehabilitation for Tongue Cancer (PGSRT Trial)

N/A
Recruiting
Led By Stephanie M Munz, DDS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a new diagnosis of a T1/T2 tongue cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

PGSRT Trial Summary

This trial will test whether a palatal augmentation prosthesis can help improve speech and swallowing function in people with tongue cancer.

Who is the study for?
This trial is for individuals newly diagnosed with early-stage (T1/T2) tongue cancer. Participants must have enough upper teeth to support a dental device used in the study. Those with recurring tongue cancer or previous radiation therapy in the head and neck area are not eligible.Check my eligibility
What is being tested?
The study is testing two methods to help speech and swallowing after oral cancer treatment: a Palatal Augmentation Prosthesis (PAP), which is a special dental device, and Articulation Therapy, which is a type of speech therapy. The effectiveness of these interventions will be compared scientifically.See study design
What are the potential side effects?
While specific side effects are not detailed here, potential issues may include discomfort from wearing the prosthesis, challenges adapting to it during speaking or swallowing, and possible irritation inside the mouth.

PGSRT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been newly diagnosed with early-stage tongue cancer.

PGSRT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Word intelligibility
Secondary outcome measures
Articulation at the word level of phonemes (consonant sounds)
Patient satisfaction with speech
Sentence intelligibility
+1 more

PGSRT Trial Design

2Treatment groups
Experimental Treatment
Group I: Prosthesis + Articulation TherapyExperimental Treatment2 Interventions
This arm will receive a palatal augmentation prosthesis with standard articulation therapy, and is the study arm.
Group II: No Prosthesis; Articulation Therapy OnlyExperimental Treatment1 Intervention
This arm will not receive a palatal augmentation prosthesis, but will receive standard articulation therapy, and is the control arm.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,482 Total Patients Enrolled
Stephanie M Munz, DDSPrincipal InvestigatorUniversity of Michigan

Media Library

Palatal Augmentation Prosthesis (PAP) (Prosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT02584270 — N/A
Tongue Cancer Research Study Groups: Prosthesis + Articulation Therapy, No Prosthesis; Articulation Therapy Only
Tongue Cancer Clinical Trial 2023: Palatal Augmentation Prosthesis (PAP) Highlights & Side Effects. Trial Name: NCT02584270 — N/A
Palatal Augmentation Prosthesis (PAP) (Prosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02584270 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are partaking in this clinical trial at its fullest capacity?

"Affirmative. Clinicaltrials.gov displays that this trial is actively seeking participants, with an initial post date of January 2nd 2018 and a recent update on February 4th 2022. The study requires 40 patients from one medical centre to participate."

Answered by AI

Is enrollment still open for this scientific investigation?

"Per the information accessible on clinicaltrials.gov, this research trial is seeking out patient volunteers and has been since it was posted in early 2018 with its latest update occurring in late 2022."

Answered by AI
~6 spots leftby Mar 2025