Neoplasms

Mouth and Tooth Diseases

All Conditions

Rare Diseases

Mouth Neoplasms

Tongue Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Tongue Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Tongue Cancer

This arm will receive a palatal augmentation prosthesis with standard articulation therapy, and is the study arm.

This arm will not receive a palatal augmentation prosthesis, but will receive standard articulation therapy, and is the control arm.

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 associated articulation therapy are necessary for this therapy to be effective.

Palatal Augmentation Prosthesis (PAP)

Subjects will receive the standard of care speech and articulation therapy regardless of which arm they are matched.

Articulation Therapy

Stephanie M Munz, DDS

Mary Burton

Stephanie Munz, DDS

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 in 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 on their 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 with the device.

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 are a control and who will not receive a PAP.

The PAP requires patients to have a dental mold created. A dentist customizes the PAP to fit their 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 to have their speech evaluated.

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

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial

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 after surgery at 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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue	NCT02584270	Tongue Neoplasm... Tongue Cancer Oral Cancer	Palatal Augment... Articulation Th...	18 Years -	University of Michigan
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue	NCT02584270	Tongue Neoplasm... Tongue Cancer Oral Cancer	Palatal Augment... Articulation Th...	18 Years -	University of Michigan

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