Use of Injectable Platelet Rich Fibrin in Lichen Planus

Overview

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

Full Title of Study: “Current Approach in the Treatment of Lichen Planus: Injectable Platelet Rich Fibrin ((İ-PRF)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: September 2, 2019

Detailed Description

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.

Interventions

  • Other: Platelet Rich Fibrin Injection
    • Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge. I- prf will be injected on one side and corticosteroid will be injected on the other side in patients with bilateral oral lichen planus. Once a week in the first month after treatment and one time at the end of the second month, the patient will be called to the control.
  • Drug: Corticosteroid
    • Corticosteroid injection

Arms, Groups and Cohorts

  • Active Comparator: experimental; Corticosteroid
    • Intralesional corticosteroid administration
  • Experimental: Experimental; Injectable Platelet rich fibrin
    • Injectable Platelet rich fibrin

Clinical Trial Outcome Measures

Primary Measures

  • Visual Analog Scale
    • Time Frame: 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
    • Time Frame: 6 months
    • The lesions were evaluated according to Thongprasom sign scoring system
  • Oral Health- Related Quality of Life index (OHIP-14)
    • Time Frame: 6 months
    • Patients were asked to grade the Oral Health- Related Quality of Life index

Secondary Measures

  • Oral Hygiene Index
    • Time Frame: 6 months
    • Oral Hygiene Index were evaluated.

Participating in This Clinical Trial

Inclusion Criteria

1. Oral erosive lesions were diagnosed according to Andreasen classification. 2. Histological confirmation of erosive OLP according to the World Health Organization's clinicopathological diagnostic criteria for OLP. 3. No previous treatment of oral lichen planus at least 3 months. 4. Willingness and ability to complete the present clinical trial. 5. Patients of ages above 18 years old without skin involvement. Exclusion Criteria:

1. Histological signs of dysplasia. 2. Using drugs associated with lichenoid reaction. 3. Pregnant, lactating and smoker patients. 4. Patient with systemic diseases such as diabetes mellitus, immunodysfunction, hematological and hepatological patients or had photosensitivity history.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bezmialem Vakif University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ebru Sağlam, PhD, Study Chair, Bezmialem Vakif University
    • Mustafa Tunalı, Assoc. prof., Study Director, Bezmialem VakifUniversity
    • Tuğba Ünver, PhD, Principal Investigator, Bezmialem Vakif University
    • Zeliha Betül Özsağır, Principal Investigator, Bezmialem Vakif University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.