Comparative Evaluation of the Efficacy of Dexamethasone Bioadhesive patch and Dexamethasone Intralesional injection in Oral Submucous Fibrosis-A Clinico-Sonographic Study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Significant Decrease in the VAS score, Increase in the interincisal distance (mouth opening) and decrease in the submucosal thickness (measured via USG) in intervention group than comparator group
研究概览
简要总结
Oral submucos fibrosis (OSMF), amultifactorial oral potentially malignant disorder, is prevalent in South EastAsia particularly India with increasing prevalence of 0.3% to 6.42% and amongChennai, South India is 8%. It is an insidious chronic disease affecting anypart of the oral mucosa, sometimes pharynx usually preceded by vesicleformation and is always associated with juxtaepithelial inflammatory reactionfollowed by a fibroelastic change of the lamina propria withepithelial atrophy, leading to stiffness of oral mucosa causing trismus andinability to eat. It leads to high rate of morbidity due to consequent nutritionaldeficiencies.
Currently the most accepted management ofOSMF includes intralesional injection of steroids biweekly for 6 weeks.Steroids are anti-inflammatory and anti-fibrotic. But the injections arepainful episodes and can also lead to scarring. Topicaldexamethasone loaded buccal bio-adhesive patch is a non invasive drug deliverysystem which has been used successfully in the treatment of OSMF ina pilot study.
Clinical diagnosis of OSMF is usuallymade based on several characteristic clinical features. But those aresubjective and non reliable which leads to the need of quantitative imagingtechnique to visualize and measure the clinical stage, progression of thedisease and its response to the treatment.
Hence this present study is designedto to assess the burning sensation (Numerical rating scale), mouth opening(interincisal distance), tongue protrusion, cheek flexibility, submucosalthickness, echogenicity (USG assessment), patient compliance in oralsubmucous fibrosis patients (OSMF) managed by dexamethosone loaded bio-adhesivepatch and intralesional injection at three time points, 0, 3rd and 6th weekrespectively
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed cases of Oral Submucous fibrosis
- •Willing to participate in the study.
排除标准
- •1.Previously treated and Stage IVb OSMF cases 2.Other fibrosis conditions like scleroderma, scarring, post radiation therapy 3.Immunocompromised patients and other systemic disorders like hypertension and diabetes mellitus 4.Not willing to participate in the study.
结局指标
主要结局
Significant Decrease in the VAS score, Increase in the interincisal distance (mouth opening) and decrease in the submucosal thickness (measured via USG) in intervention group than comparator group
时间窗: Baseline,3rd week, 6th week
次要结局
- Better patient compliance in study group than comparator group as mucoadhesive patch is non invasive, painless and sustained release formulation(baseline, after 6th week)