Datarkar Abhay, Akare Abhishek, Tayal Shikha
Department of Oral and Maxillofacial Surgery, Government Dental College & Hospital, Medical Campus, Medical Square, Nagpur, Maharashtra 440003 India.
J Maxillofac Oral Surg. 2020 Dec;19(4):532-538. doi: 10.1007/s12663-019-01248-3. Epub 2019 May 28.
This clinical randomized controlled trial evaluates the effectiveness of prednisolone mouthwash as a treatment modality for moderately advanced cases of oral submucous fibrosis.
Sixty-four patients were enrolled for the study and randomized into two groups ( = 32 in each group). The experimental group was treated with prednisolone mouthwash and antioxidant capsule as per GDCH Nagpur protocol, and control group was treated with antioxidant capsule only. The primary outcome variables were interincisal mouth opening, burning sensation, and recurrent ulceration. Clinical responses were obtained at the time of the allocation, at 1, 3, 6, and 9 months into the intervention, and 6 months thereafter.
The average increased mouth opening achieved was 10.46 mm ( < 0.5) in group A (experimental group) and only 1.04 mm ( < 0.5) mm in group B (control group). In addition, there was a significant difference in relief of burning sensation and recurrent ulceration. Relief of burning sensation and recurrent ulceration was within 12.81 and 10.93 days, respectively, in group A when compared to group B which was within 21.56 and 20.06 days, respectively.
We conclude that in our trial, prednisolone mouthwash with antioxidants was seen to be efficacious, safe, and reliable in the management of oral submucous fibrosis.
本临床随机对照试验评估泼尼松龙漱口水作为口腔黏膜下纤维化中度进展病例治疗方式的有效性。
64名患者纳入本研究并随机分为两组（每组 = 32人）。实验组按照那格浦尔政府牙科学院协议接受泼尼松龙漱口水和抗氧化胶囊治疗，对照组仅接受抗氧化胶囊治疗。主要结局变量为切牙间开口度、烧灼感和复发性溃疡。在分组时、干预开始后的1、3、6和9个月以及此后6个月获取临床反应。
A组（实验组）平均开口度增加10.46毫米（<0.5），而B组（对照组）仅增加1.04毫米（<0.5）。此外，在烧灼感缓解和复发性溃疡方面存在显著差异。与B组相比，A组烧灼感缓解和复发性溃疡缓解分别在12.81天和10.93天内，而B组分别在21.56天和20.06天内。
我们得出结论，在我们的试验中，含抗氧化剂的泼尼松龙漱口水在口腔黏膜下纤维化的管理中被认为是有效、安全且可靠的。
