Abstract
Purpose: The purpose of this study was to assess the efficacy of a membrane obturator using a thick dental dam. The objectives were to compare speech handicap levels, swallowing handicaps, and the health-related quality of life in patients wearing the membrane obturator and the rigid obturator.
Materials and Methods: The VELOMEMBRANE trial was designed as a superiority, open-label, two-way, random crossover clinical trial. Adult patients exhibiting velar or palatovelar defects after tumor resection and requiring rigid obturator-mediated prosthetic rehabilitation were recruited. The participants were randomly allocated an order for wearing both prostheses for two 1-month periods. Outcomes were reported by completing questionnaires such as the Voice Handicap Index (VHI), the Deglutition Handicap Index (DHI) and health-related quality of life scores of the European Organization for Research and Treatment of Cancer (EORTC).
Results: One inclusion center had to close during the Covid-19 pandemic outbreak. Only 4 of the 14 patients could be recruited during the time of the study. These preliminary results showed that defects characterized by a full resection of the soft palate could benefit from the new system. However, the traditional rigid obturators were often more satisfactory. The main issue with the new membrane obturator was the need for almost-daily membrane change.
Conclusions: This study documented the utility of this new medical device. With future improvement in the membrane biomaterial, this system may greatly improve the management and quality of life of patients with some specific types of acquired velar insufficiency. (Int J Maxillofac Prosthetics 2025;8:55-64)