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临床试验/CTRI/2023/11/060376
CTRI/2023/11/060376尚未招募不适用

Comparative Evaluation of Conventional Nasolabial flap and Nasolabial flap with Fishtail Modification in patients undergoing surgical release of fibrous bands in Oral Submucous Fibrosis

Datta Meghe Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年7月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Functional outcomes: Rate of flap failure

研究概览

简要总结

Oral submucous fibrosis is a widespread condition affecting millions in the South Asian subcontinent. It is mainly prevalent due to the habitual consumption of Betel Nut, a variety of smokeless tobacco, which causes severe fibrosis of the oral mucosa, eventually leading to depleted quality of life due to reduction in mouth opening.

There are various treatment modalities available, but surgery remains the one with best outcomes. Different flaps have been used to reconstruct the fibrotomy defect, the nasolabial flap is mostly preferred due to its versatility. We have brought forth a modification of this flap which will hypothetically reduce certain post operative complications such as tearing of the oral commissure, angular cheilitis, and widening of the corner of mouth.

研究设计

研究类型
Interventional

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 Grade IV OSMF.

排除标准

  • 未提供

结局指标

主要结局

Functional outcomes: Rate of flap failure

时间窗: Follow up at 2 weeks and 4 weeks

次要结局

  • Aesthetic outcomes: Widening of oral commissure, tearing at corner of mouth(Follow up at 2 weeks & 4 weeks)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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