Efficacy of silicone soft reliner on the obturator prosthesis after maxillectomy for oral malignant tumors: A single-arm prospective interventional study

Abstract

Background: There is insufficient evidence for the efficacy of silicone soft reliner on the obturator prosthesis after maxillectomy for oral malignant tumors. Objective: To verify the efficacy of silicone soft reliner on the obturator prosthesis after maxillectomy, by evaluating masticatory performance and quality of life (QoL). Methods: This was a single-arm prospective interventional study, verifying the efficacy of silicone soft reliner (GC RELINE II®) on the maxillary obturator prosthesis. Data were obtained from a comparison of the endpoints after 14 days of continuous use of acrylic and silicone soft-lined prostheses. The primary endpoint was masticatory performance. The secondary endpoints were occlusal performance and oral health-related QoL (OHRQoL). The masticatory performance, occlusal performance, and OHRQoL were assessed by glucose concentration, maximum bite force, and the Japanese version of Oral Health Impact Profile (OHIP-J49), respectively. Results: This study included five patients (two males, three females), aged between 71 and 88 years, with a median of 74 years. The median of glucose concentration indicated a statistically significant improvement between the acrylic resin (99.6 mg/dL) and silicone soft reliner (126.0 mg/dL) obturator prosthesis (p =.043). There was no significant difference in the median of maximum bite force between the acrylic resin (302.0 N) and silicone soft reliner (250.0 N) obturator prosthesis (p =.893). Functional limitations domain of the OHIP-J49 indicated a statistically significant improvement between the acrylic resin and silicone soft reliner obturator prosthesis (p =.043). Conclusions: This study indicated that an obturator relined with soft silicone improved masticatory performance and the OHRQoL post-maxillectomy.