Use of Injectable Platelet Rich Fibrin in Lichen Planus

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

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

Study Overview

• Status: Completed
• Conditions: Lichen Planus
• Intervention / Treatment: Drug: Corticosteroid; Other: Platelet Rich Fibrin Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • İstanbul, Fatih, Turkey, 34093
      • Ebru Sağlam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: experimental; Corticosteroid; Intralesional corticosteroid administration	Drug: Corticosteroid; Corticosteroid injection
Experimental: Experimental; Injectable Platelet rich fibrin; Injectable Platelet rich fibrin	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Hygiene Index	Oral Hygiene Index were evaluated.	6 months

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Study Chair: Ebru Sağlam, PhD, Bezmialem Vakif University; Study Director: Mustafa Tunalı, Assoc. prof., Bezmialem VakifUniversity; Principal Investigator: Tuğba Ünver, PhD, Bezmialem Vakif University; Principal Investigator: Zeliha Betül Özsağır, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Actual): September 2, 2019
• Study Completion (Actual): September 2, 2019

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; Platelet Activation; Pain Measurement
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus
• Other Study ID Numbers: EbSAGLAM2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No