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临床试验/NCT03265093
NCT03265093已完成不适用

Current Approach in the Treatment of Lichen Planus: Injectable Platelet Rich Fibrin ((İ-PRF)

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年5月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis, immunity and epithelial proliferation phases. over a decade has since past since PRF was developed and many clinicians now point to the potential use of a liquid version of PRF. a liquid injectable-platelet-rich fibrin (i-PRF) was developed by modifying spin centrifugation forces. At lower centrifugation speeds and by utilizing non-glass centrifugation tubes, the fibrin coagulation could be slowed down at early time points thus generating an injectable PRF. Much like traditional PRF, i-PRF contains an increase in leukocyte number and is further able to stimulate growth factor release.

Lichen planus is a common chronic mucocutaneous inflammatory disorder which generally affect s middle aged adults. Therapeutic methods including topical and systemic corticosteroids for the treatment of oral lichen planus (OLP) are suggested. However, long

-term use of corticosteroids may be associated with local and systemic complications, and moreover, some patients may not be responsive.

The investigators aimed to apply a treatment of autogenous origin (including no foreign products), considering the side effects of our corticosteroids. The study was designed as a split mouth.

The investigators planned to administer I-PRF to one side and intralesional corticosteroid therapy to the other side at patients with bilateral atrophic / erosive oral lichen planus lesions

详细描述

Lichen planus diagnosis will be made histopathologically. Intraoral photographs and measurements will be taken at the beginning of the treatment and 2 months after the treatment is finished.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Investigator, Outcomes Assessor

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Oral erosive lesions were diagnosed according to Andreasen classification.
  • Histological confirmation of erosive OLP according to the World Health Organization's clinicopathological diagnostic criteria for OLP.
  • No previous treatment of oral lichen planus at least 3 months.
  • Willingness and ability to complete the present clinical trial.
  • Patients of ages above 18 years old without skin involvement.

排除标准

  • Histological signs of dysplasia.
  • Using drugs associated with lichenoid reaction.
  • Pregnant, lactating and smoker patients.
  • Patient with systemic diseases such as diabetes mellitus, immunodysfunction, hematological and hepatological patients or had photosensitivity history.

研究组 & 干预措施

experimental; Corticosteroid

Active Comparator

Intralesional corticosteroid administration

干预措施: Corticosteroid (Drug)

Experimental; Injectable Platelet rich fibrin

Experimental

Injectable Platelet rich fibrin

干预措施: Platelet Rich Fibrin Injection (Other)

结局指标

主要结局

Visual Analog Scale

时间窗: 6 months

Patients were asked to grade the severity of their symptoms in numbers from 1(very mild pain) to 100 (very sever pain) on the visual analog scale in each visit.

Thongprasom sign scoring system

时间窗: 6 months

The lesions were evaluated according to Thongprasom sign scoring system

Oral Health- Related Quality of Life index (OHIP-14)

时间窗: 6 months

Patients were asked to grade the Oral Health- Related Quality of Life index

次要结局

  • Oral Hygiene Index(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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