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

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.