Comparative assessment of efficacy of intralesional injection of placentrex, hyalouronidase and dexamethasone in treatment of Oral submucous fibrosis- A randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The significant increase in the mouth-opening and relief of burning sensation with combination intralesional injection therapy in OSMF
研究概览
简要总结
Oral submucous fibrosis (OSMF) is a very common premalignant condition in India, with high rates of malignant transformation. The most prevalent are Grade 2 and 3 OSMF cases, and therefore, various treatment modalities have been tried in these cases. The aim of the present study was to compare the efficacy of intralesional injection of placentrex, hyaluronidase, and dexamethasone in the treatment of OSMF
A single-center open label randomized control trial will be conducted on 160 patients of Grade 2 and 3 OSMF, divided into four groups as follows: Group 1: 40 patients who will have various oral supplements only; Group 2: 40 patients will be given intra-lesional injection of 2ml placentrex, mixed with 1ml of 2% lignocaine; Group 3: 40 patients will have injection of 1500 IU of 1ml hyaluronidase, with 1ml dexamethasone, mixed with 1ml of 2% lignocaine; Group 4: 40 patients will receive a combination of the above 2 groups (2ml placentrex, 1ml hyaluronidase, 1ml dexamethasone, mixed with 1 ml of 2% lignocaine). The patients will be evaluated for mouth opening, and burning sensation with Likert five-point scale at baseline, one week, fourth week, eighth week, twelfth week, and twelfth month. Analysis of variance (ANOVA) will be used for inter, and intra-group comparison for assessment of mouth opening, and Kruskal Wallis test will be used for assessment of burning sensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •The patients diagnosed with Grade 2, and Grade 3 of oral submucous fibrosis (OSMF), as evident from their detailed clinical and histopathological examination.
排除标准
- •The patients with previous treatment of OSMF, patients who had Grade 1 and 4 OSMF, who were allergic to placental extract, steroids, and hyaluronidase, the patients who did not give their consents, who have syndromic or systemic disease with mouth ulcers, who had undergone radiotherapy sessions leading to oral ulcers, those who gave previous history of major surgery in the oral cavity, patients with carcinoma of oral cavity, were excluded from the study.
结局指标
主要结局
The significant increase in the mouth-opening and relief of burning sensation with combination intralesional injection therapy in OSMF
时间窗: at Baseline, 4th week, 8th week, 12th week and 12th month.
次要结局
- The significant increase in the mouth-opening and relief of burning sensation with combination intralesional injection therapy in OSMF(At baseline)
研究者
Jay Goyal
Jawahar Medical Foundations Aannasaheb Chudaman Patil Memorial Dental College