Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
Department of Pharmaceutics, Faculty of pharmacy, Alexandria University, Alexandria, Egypt.
Oral Dis. 2021 Jul;27(5):1197-1204. doi: 10.1111/odi.13650. Epub 2020 Oct 27.
The aim of this clinical trial is to evaluate the effectiveness of topical oral vitamin D gel in prevention of radiation-induced oral mucositis.
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.
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.
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.
本临床试验旨在评估局部口腔维生素 D 凝胶预防放射性口腔黏膜炎的效果。
对 45 例头颈部癌症患者进行了三臂随机对照临床试验。第一组：常规治疗。第二组：局部口腔维生素 D 凝胶。第三组：局部口腔维生素 D 凝胶加常规治疗。所有患者在放疗开始后 3 周和 6 周时进行临床检查，评估疼痛和 WHO 口腔黏膜炎评分。
放疗 6 周后，对照组（33.5%）患者发生重度口腔黏膜炎，而两个试验组（维生素 D 组和联合治疗组）的患者仍为轻度或完全缓解。联合治疗组的平均疼痛评分显著下降，而维生素 D 组也有接近的下降，对照组则没有。
局部口腔维生素 D 凝胶可降低放射性口腔黏膜炎的发生和放疗期间的疼痛感觉，特别是与常规治疗药物联合使用时效果更佳。
