Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02584270
Study type Interventional
Source University of Michigan
Contact Stephanie M Munz, DDS
Phone 734 936-8289
Email smmunz@med.umich.edu
Status Recruiting
Phase N/A
Start date January 2, 2018
Completion date June 2026

See also
  Status Clinical Trial Phase
Recruiting NCT06031337 - Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
Completed NCT00158678 - IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC Phase 3
Completed NCT00933387 - A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma Phase 2
Enrolling by invitation NCT05030597 - Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma N/A
Completed NCT03682562 - Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
Recruiting NCT03684707 - Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions Phase 4
Recruiting NCT06130332 - Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma(HNC-SYSU-004) Phase 2
Recruiting NCT04372914 - Prevention of Oral DNA Damage by Black Raspberries N/A
Active, not recruiting NCT03529422 - Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN Phase 2
Recruiting NCT03686020 - Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
Not yet recruiting NCT06060288 - Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening
Withdrawn NCT00951470 - Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema N/A
Completed NCT00964977 - Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. Phase 3
Completed NCT01418118 - Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery Phase 4
Active, not recruiting NCT00232960 - Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC N/A
Recruiting NCT05429099 - Mandibular Reconstruction Preplanning (ViPMR) Phase 2/Phase 3
Completed NCT04614896 - Use of Ultrasound for Measuring Size of Oral Tongue Cancers N/A
Recruiting NCT03685409 - Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions Phase 3
Completed NCT00402779 - Erlotinib Prevention of Oral Cancer (EPOC) Phase 3
Recruiting NCT05153733 - Improved Implant for Reconstruction Purposes After Mandibular Resection N/A