Efficacy of Injection Placentrex, Platelet Rich Plasma (PRP) and Triamcinolone with Hyaluronidase in the management of oral submucous fibrosis: A Randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in interincisal mouth opening (in mm)
研究概览
简要总结
Patients diagnosed with OSMF and clinically graded as stage II and III OSMF according to Khanna and Andrade grading will be included. Demographic data with detailed history will be obtained about personal, habit and medical history followed by clinical examination and following parameters will be evaluated by mouth opening by maximal interincisal distance using vernier callipers, burning sensation will be assessed subjectively using visual analogue scale, colour of mucosa will be evaluated under natural light and this data will be numbered as pink-1, pale pink-2, pale-3, blanched-4.The patients will be randomly allocated into the three groups. Randomization will be done according to computer generated block design. All patients will be counselled for habit cessation and will be undergoing oral prophylaxis before commencing the injection therapy. Intramucosal injections will be administered on the affected buccal mucosa and retromolar region o.2ml in each site once weekly for 6 weeks. All patients will be trained and instructed to do mouth opening exercises using Heisters screw in every follow-up throughout treatment period. Parameters will be evaluated every 2 weeks within the 6 weeks of injection therapy followed by 3 months
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with stage II and III oral submucous fibrosis grading based on mouth opening ranging from 15mm to 35mm Patients having oral submucous fibrosis due to tobacco chewing habit Patients who have already quit the tobacco chewing habit.
排除标准
- •Patients with stage I and IV OSMF grading based on mouth opening (less than 15mm and more than 35mm) Patients who have already undergone surgeries/ medicinal treatment for oral submucous fibrosis in the past Patients with systemic sclerosis or oral submucous fibrosis due to any other systemic condition.
结局指标
主要结局
Change in interincisal mouth opening (in mm)
时间窗: Baseline (Week 0),Week 2, Week 4, Week 6, 3 months
measured using vernier calliper between upper and lower central incisors
时间窗: Baseline (Week 0),Week 2, Week 4, Week 6, 3 months
次要结局
- Reduction in burning sensation in oral mucosa using Visual Analog Scale(VAS)(Baseline (Week 0),Week 2, Week 4, Week 6, 3 months)
- Change in blanching of oral mucosa assessed by clinical grading (subjective scale)(Baseline (Week 0),Week 2, Week 4, Week 6, 3 months)
研究者
Dr Shreeya Sharma
All India Institute of Medical Sciences, Rajkot, Gujarat
