Randomized clinical trial on the effect of oral care on the prevention of severe radiation-induced oral mucositis

2016 Fiscal Year Final Research Report

• Project/Area Number: 26463018
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Surgical dentistry
• Research Institution: Nagasaki University
• Principal Investigator: UMEDA Masahiro 長崎大学, 医歯薬学総合研究科(歯学系), 教授 (60301280)
• Project Period (FY): 2014-04-01 – 2017-03-31
• Keywords: 放射線性口内炎 / 口腔管理 / 予防 / ランダム化比較試験

Outline of Final Research Achievements

Severe oral mucositis often occurs in patients who undergo radiotherapy (RT) or chemo-radiotherapy (CRT) to the oral region. The aim to the study is to investigate the effectiveness of oral management on development of grade 3 oral mucositis in patients with oral cancer undergoing RT by a multicenter, randomized clinical trial. A total of 88 patients were enrolled in the study, and randomly divided into the intervention and the control group. Patients in the intervention group received spacer, administration of pilocarpine and dexamethasone ointment. Various demographic, tumor-related, and treatment-related factors were examined. The primary endpoint is development of grade 3 oral mucositis. Oral care intervention did not prevent grade 3 oral mucositis in all 88 patients. However, when patients were divided into RT and CCRT groups, the occurrence rate of grade 3 mucositis was significantly lower in the oral care group than that in the control group in patients undergoing RT alone.

Free Research Field

口腔外科学