跳至主要内容
临床试验/CTRI/2025/07/091800
CTRI/2025/07/091800尚未招募4 期

Efficacy of Injection Placentrex, Platelet Rich Plasma (PRP) and Triamcinolone with Hyaluronidase in the management of oral submucous fibrosis: A Randomized control trial

Self-sponsored1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年8月31日最近更新:

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

发起方
Self-sponsored
申办方类型
Other [Patients will be bearing the cost of treatments ]
责任方
Principal Investigator
主要研究者

Dr Shreeya Sharma

All India Institute of Medical Sciences, Rajkot, Gujarat

研究点 (1)

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