Comparative Evaluation of Efficacy of Dexamethasone 4mg and Hyaluronidase 0.5mg Mucoadhesive Patch with Intralesional Injection of Dexamethasone and Hyaluronidase for Oral Submucous Fibrosis Stage II: A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Increase in mouth opening
研究概览
简要总结
This randomized controlled trial aims to compare a non invasive mucoadhesive patch containing 4 mg dexamethasone and point 5 mg hyaluronidase applied twice weekly with mouth opening exercises versus traditional intralesional injections 4 mg dexamethasone 1500 IU hyaluronidase lignocaine in 80 Stage II Oral Submucous Fibrosis patients over a 3 month period The study conducted in a Central India oral medicine department will assess improvements in interincisal mouth opening and reduction of burning sensation using vernier caliper measurements and VAS scores at monthly intervals Data will be analyzed with STATA t tests ANOVA non parametric tests as needed with significance set at p 005 Results could validate a sustained release patient friendly patch as a viable alternative to injections improving compliance and comfort in OSMF management
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient aged between 16 to 60 years No history of prior treatment for the same Patients with OSMF stage II.
排除标准
- •Patients with known history of hypersensitivity to dexamethasone & hyaluronidase Patients who are diagnosed with other intra oral lesions Pregnant women and lactating mothers Immunocompromised patients.
结局指标
主要结局
Increase in mouth opening
时间窗: baseline, 1st, 2nd, and 3rd month
次要结局
- Reduction in burning sensation(baseline, 1st, 2nd, and 3rd month)
研究者
Dr Aishwarya Bhave
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna
