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

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Tongue neoplasm
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Brief Title

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

Official Title

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

Brief Summary

      This study will fill a scientific gap in the current knowledge providing data for evaluation
      of the palatal augmentation prosthesis 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 morbidity of oral cancer therapy, namely speech and
      swallowing function in a population of patients with T1/T2 tumors of the tongue who are not
      currently routinely recommended for a palatal augmentation prosthesis.

Study Type

Interventional

Primary Outcome

Word intelligibility

Secondary Outcome

 Sentence intelligibility

Condition

Tongue Neoplasms

Intervention

Palatal Augmentation Prosthesis (PAP)

Study Arms / Comparison Groups

 Prosthesis + Articulation Therapy
Description:  This arm will receive a palatal augmentation prosthesis with standard articulation therapy, and is the study arm.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

40

Start Date

January 2, 2018

Completion Date

June 2024

Primary Completion Date

January 2024

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stephanie M Munz, DDS, 734 936-8289, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02584270

Organization ID

HUM00093723.1

Responsible Party

Principal Investigator

Study Sponsor

University of Michigan

Study Sponsor

Stephanie M Munz, DDS, Principal Investigator, University of Michigan

Verification Date

February 2022