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临床试验/CTRI/2025/12/099212
CTRI/2025/12/099212尚未招募Phase 3 4

Comparison of efficacy of Intralesional Platelet Rich Plasma(PRP) with Intralesional Dexamethasone and Hyaluronidase in the treatment of Oral Submucous Fibrosis: A Randomized Controlled Clinical Trial

HARITHA S1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月20日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1

研究概览

简要总结

The aim of the study is to compare the efficacy of intralesional Platelet Rich Plasma (PRP) with intralesional Dexamethasone and Hyaluronidase in the treatment of Oral Submucous Fibrosis with Spirulina as an adjuvant .Out patients reporting to the Department of Oral Medicine and Radiology, Government Dental College and Hospital ,Vijayawada who are diagnosed clinically with Oral Submucous Fibrosis and requires treatment will be enrolled in the study. Detailed history of health and habit will be taken and patient will be motivated to quit the habit. The intended procedure will be explained to every patient and an informed consent will be obtained thereafter. Selected patients will be allocated into group A and B randomly. Group A:Consists of 15 OSMF patients who will be administered intralesional injection of PRP 1 ml once a week with oral antioxidant tablets containing Spirulina 500mg once daily for a period of 8 weeks. Group B:Consists of 15 OSMF patients who will be administered Intralesional injection of Dexamethasone 4mg/ml (1.5ml)+ Intralesional injection of Hyaluronidase 1500 IU + with 0.5ml Lignocaine HCL two times per week combined with oral antioxidant tablets containing Spirulina 500mg once daily for a period of 8 weeks.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

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

入选标准

  • Male and female patients of age 21-60 years clinically diagnosed with OSMF.
  • Patients who are willing to quit the habit of chewing tobacco and areca nut.
  • Patients who will agree to come for regular follow-up visits will be included.

排除标准

  • Patients who are currently under treatment for OSMF.
  • Patients under treatment for chronic systemic diseases and blood disorders.
  • OSMF patients with severe restricted mouth opening where there is no adequate access to administer intralesional injections.
  • Patients under treatment for other OPMDs.
  • Pregnant and lactating patients.

研究者

发起方
HARITHA S
申办方类型
Other [self funded]
责任方
Principal Investigator
主要研究者

Haritha S

GOVERNMENT DENTAL COLLEGE AND HOSPITAL, VIJAYAWADA

研究点 (1)

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