[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100253924":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":64,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Prosthesis + Articulation Therapy","EXPERIMENTAL","This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm",[13,14],"Device: Palatal Augmentation Prosthesis (PAP)","Other: Articulation Therapy",{"label":16,"type":6,"description":17,"interventionNames":18},"No Prosthesis; Articulation Therapy Only","This arm will not receive a PAP (palatal augmentation prosthesis), but will receive standard articulation therapy. This is the control arm.",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","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.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Articulation Therapy","Subjects will receive the standard of care speech and articulation therapy in either arm.",[16,9],[31],"Speech Therapy",[33],{"name":34,"affiliation":5,"role":35},"Stephanie M Munz, DDS","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":25,"email":40},"CONTACT","734 936-8289","smmunz@med.umich.edu",{"name":42,"role":38,"phone":25,"phoneExt":25,"email":43},"Mary Burton","mjburt@med.umich.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-83.74088,42.27756,{"lat":57,"lon":56},[60,63],{"name":61,"role":38,"phone":62,"phoneExt":25,"email":40},"Stephanie Munz, DDS","734-936-8289",{"name":42,"role":38,"phone":25,"phoneExt":25,"email":43},{"type":35,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Stephanie M. Munz","Clinical Assistant Professor","100253924","prosthesis-guided-speech-rehabilitation-of-t1t2-cancers-of-the-tongue-100253924",false,"NCT02584270","Prosthesis Guided Speech Rehabilitation of T1\u002FT2 Cancers of the Tongue","Prosthesis Guided Speech Rehabilitation of T1\u002FT2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial","PGSRT","Inclusion Criteria:\n\n* Patients with a new diagnosis of a T1\u002FT2 tongue cancer\n\nExclusion Criteria:\n\n* Patients with recurrent disease\n* Patients with a history of prior head and neck radiation therapy\n* Patients who lack adequate maxillary dentition to support a palatal augmentation prosthesis","ALL","18 Years",{"count":78,"type":79},40,"ESTIMATED","INTERVENTIONAL",[82],"NA","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.\n\nPositive 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.",[85,86,87],"Tongue Neoplasms","Tongue Cancer","Oral Cancer",[89],"palatal drop prosthesis","2026-05-05",{"date":92,"type":93},"2026-05-08","ACTUAL",{"date":95,"type":93},"2018-01-02",{"date":97,"type":79},"2028-06",{"name":5,"class":6},1]