A Randomised, Double - blind, Multiple arm Trial toCompare the Efficacy of Submucosal injections of Hyaluronidase,Dexamethasone and Combination of Dexamethasone and Hyaluronidase inthe Management of Oral Submucous Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.Increase in mouth opening in millimetres.
研究概览
简要总结
Numerous treatment modalities have been advocated for oral submucous fibrosis over years, but it is not yet fully standardized. Moreover , RCT’s are lacking. This RCT is done to acess a better treatment option. The efficacy of local sub-mucosal injections of hyaluronidase, dexamethasone and their combinations are tested and evaluated for improvements in mouth opening, pain , burning sensation and tongue protrusion. The results are compared and confirmed with subsequent histopathological studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients clinically diagnosed and histopathologically confirmed as OSF.
排除标准
- •Patients having severe systemic problems or pregnant ladies, patients having history of drug allergy or hypersensitivity to hyaluronidase, dexamethasone or lignocaine, a previous history of treatment for OSF or malignancy arising in OSF or patients unwilling for treatment.
结局指标
主要结局
1.Increase in mouth opening in millimetres.
时间窗: at the start of therapy | 2 weeks after final injection | 1 month, 2month, three month and 6 month after final injection
2.decrease in subjective symptoms a) pain b) burning sensation of buccal mucosa c)tightness of buccal mucosa
时间窗: at the start of therapy | 2 weeks after final injection | 1 month, 2month, three month and 6 month after final injection
all the above changes are acessed using numeric rating scale.d) protrusion of tongue relative to the alveolar ridge is asessed.
时间窗: at the start of therapy | 2 weeks after final injection | 1 month, 2month, three month and 6 month after final injection
3.histopathologic improvements.
时间窗: at the start of therapy | 2 weeks after final injection | 1 month, 2month, three month and 6 month after final injection
次要结局
- 1.Increase in mouth opening in millimetres.(2.decrease in subjective symptoms a) pain b) burning sensation of buccal mucosa c)tightness of buccal mucosa)