OBJECTIVES: The aim of this clinical trial is to evaluate the effectiveness of topical oral vitamin D gel in prevention of radiation-induced oral mucositis. MATERIAL AND METHODS: A three-armed randomized controlled clinical trial on forty-five head and neck cancer patients was conducted. First group: conventional treatment. Second group: Topical oral vitamin D gel. Third group: topical oral vitamin D gel plus the conventional treatment. All the patients were examined clinically three and six weeks after the start of radiotherapy for pain and WHO mucositis score. RESULTS: After 6 weeks of radiotherapy, (33.5%) the patients in control group developed high-grade severity of oral mucositis while the patients in the two-test groups "vitamin D group and combined therapy group" remained with low-grade severity or with complete remission. Mean pain scores showed a significant decrease in the combined therapy group and to a close degree in vitamin D group rather than the control group. CONCLUSION: Topical oral vitamin D gel has a beneficial effect in lowering oral mucositis development and in reducing pain sensation during the radiation period especially when combined with conventional therapeutic agents.
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