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临床试验/CTRI/2025/07/090605
CTRI/2025/07/090605尚未招募3 期

Comparative Evaluation of Efficacy of Dexamethasone 4mg and Hyaluronidase 0.5mg Mucoadhesive Patch with Intralesional Injection of Dexamethasone and Hyaluronidase for Oral Submucous Fibrosis Stage II: A Randomized Controlled Trial.

Dr Aishwarya Bhave1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月16日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Increase in mouth opening

研究概览

简要总结

This randomized controlled trial aims to compare a non invasive mucoadhesive patch containing 4 mg dexamethasone and point 5 mg hyaluronidase applied twice weekly with mouth opening exercises versus traditional intralesional injections 4 mg dexamethasone 1500 IU hyaluronidase lignocaine in 80 Stage II Oral Submucous Fibrosis patients over a 3 month period The study conducted in a Central India oral medicine department will assess improvements in interincisal mouth opening and reduction of burning sensation using vernier caliper measurements and VAS scores at monthly intervals Data will be analyzed with STATA t tests ANOVA non parametric tests as needed with significance set at p 005 Results could validate a sustained release patient friendly patch as a viable alternative to injections improving compliance and comfort in OSMF management

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
16.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient aged between 16 to 60 years No history of prior treatment for the same Patients with OSMF stage II.

排除标准

  • Patients with known history of hypersensitivity to dexamethasone & hyaluronidase Patients who are diagnosed with other intra oral lesions Pregnant women and lactating mothers Immunocompromised patients.

结局指标

主要结局

Increase in mouth opening

时间窗: baseline, 1st, 2nd, and 3rd month

次要结局

  • Reduction in burning sensation(baseline, 1st, 2nd, and 3rd month)

研究者

发起方
Dr Aishwarya Bhave
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Aishwarya Bhave

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna

研究点 (1)

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