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临床试验/CTRI/2026/04/108276
CTRI/2026/04/108276尚未招募3 期

Comparative evaluation of intralesional triamcinolone and hyaluronidase versus platelet rich fibrin iPRF and hyaluronidase in the treatment of grade II and grade III oral submucous fibrosis a randomized clinical trial

Dr Parag Wankhede1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年4月27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
15
试验地点
1

研究概览

简要总结

This study is a prospective randomized split-mouth clinical trial designed to evaluate and compare the clinical efficacy of two intralesional treatment modalities in the management of Oral Submucous Fibrosis (OSMF).

A total of 20 patients diagnosed with Grade II and Grade III OSMF were included. In each patient, both treatment modalities were administered on opposite sides of the buccal mucosa, allowing intra-individual comparison. The interventions included:

  • Injectable Platelet-Rich Fibrin (iPRF) with Hyaluronidase (test side)
  • Triamcinolone Acetonide with Hyaluronidase (control side)

Treatment was carried out over 10 bi-weekly sessions, with regular follow-up assessments.

The primary clinical parameters evaluated were:

  • Burning sensation (VAS)
  • Pain during mouth opening (VAS)
  • Cheek flexibility (measured in cm)
  • Maximum mouth opening (interincisal distance)

The study aimed to determine whether iPRF, a regenerative therapy, provides superior clinical outcomes compared to conventional corticosteroid therapy, particularly in terms of symptomatic relief and functional improvement.

Statistical analysis was performed using paired comparisons and repeated measures ANOVA to assess intra-group and inter-group differences.

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 70.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 years and above.
  • Patients clinically diagnosed with Grade II and Grade III Oral Submucous Fibrosis according to Khanna and Andrade classification (1995).
  • Presence of bilateral fibrous bands in the buccal mucosa.
  • Patients willing to participate in the study and provide written informed consent.
  • Patients willing to cease the habit completely.

排除标准

  • Patients currently taking systemic medications that may influence treatment outcomes.
  • Patients with platelet disorders or coagulation abnormalities.
  • Patients with systemic conditions contraindicating minor procedures.

研究者

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

Dr Parag Wankhede

Dr. D. Y. Patil Dental College and Hospital, Pune

研究点 (1)

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