Function after a maxillectomy reconstructed with an obturator

Not yet recruiting

• Conditions: tumor invading the maxillary sinus; upper jaw tumor; 10027655; 10019190

• Registration Number: NL-OMON32896
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients
- having undergone a maxillectomy 1998-2008
- reconstructed with an obturator
- controlled by the dentists/ maxillofacial prosthetics of the Antoni van Leeuwenhoek Hospital

Exclusion Criteria

Patients
- that are not mobile or healthy enough to come for an extra visit to the hospital
- having a local recurrence which is not possible to treat anymore, or still planned to be treated
- with lack of basic written and oral command of the Dutch language
- without dental reconstruction at the moment
- with erious psychiatric or cognitive problems that would preclude completion of self-report questionnaires
- living more than 45 minutes distance from the AvL, if it is not possible to combine the visit with a control visit

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measurements:<br /><br>- nasalance on a VAS score<br /><br>- maximal mouthopening<br /><br>- mixing ability index<br /><br>- quality of life and obturator functioning questionnaires<br /><br><br /><br>stratified for:<br /><br>- size of maxilla defect (Brown classification)<br /><br>- remaining percent hard palate and soft palate contralaterally<br /><br>- resection of the premaxilla<br /><br>- history of adjuvant radiotherapy<br /><br>- presence of natural dentition</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Primary outcome measurements stratified for:<br /><br>- age<br /><br>- sex</p><br>