CTRI/2020/09/027836尚未招募不适用
“Comparison of Combination of Intralesional Pentoxyphylline and Dexamethasone, with Intralesional Pentoxyphylline, Intralesional Dexamethasone alone in Treatment of Oral submucous fibrosis.â€
sharad pawar dental college wardha maharashtra1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- mouth opening
研究概览
简要总结
This study is a randomized single blind parallel group single centered trial comparing the efficacy of combination of intralesional Pentoxyphylline 1mg/ml and intralesional dexamethasone 4ml biweekly for 3 months with intralesional pentoxyphylline and intralesional dexamethasone alone in 75 patients in oral submucous fibrosis patients that will be conducted at one centre in India. The primary outcome measure will be Interincisal opening at 6 months. The secondary outcomes will be reduction in burning sensation, functional improvement, quality of life, downstaging of Grading of oral submucous fibrosis will be measured every 1 month for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients clinically diagnosed as having Grade II, III IV OSMF.
- •No obvious malignant disease in surroundings.
排除标准
- •Patient allergic or hypersensitive to the prescribed drugs.
- •Patients who have previously exhibited intolerance to PTX or other xanthines such as caffeine, theophylline, etc.
- •Patient who have been treated with Intralesional injections/surgical modality.
- •Systemically compromised patients.
- •Pregnant or lactating mothers.
- •Patients with trismus of oral cavity due to reasons other than OSMF like TMJ ankylosis, Temporomandibular disorders, Myositis Ossificans etc.
结局指标
主要结局
mouth opening
时间窗: every 1 month for 6 months
次要结局
- Down staging of grading of Oral Submuacous fibrosis(every 1 month for 6 months)
- quality of life(every 1 month for 6 months)
- reduction in burning sensation(every 1 month for 6 months)
- Functional improvement(every 1 month for 6 months)
研究者
研究点 (1)
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