search
Back to results

Use of Injectable Platelet Rich Fibrin in Lichen Planus

Primary Purpose

Lichen Planus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Platelet Rich Fibrin Injection
Corticosteroid
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Planus focused on measuring Pain Measurement, Platelet Activation, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ebru SAĞLAM

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

experimental; Corticosteroid

Experimental; Injectable Platelet rich fibrin

Arm Description

Intralesional corticosteroid administration

Injectable Platelet rich fibrin

Outcomes

Primary Outcome Measures

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.
Thongprasom sign scoring system
The lesions were evaluated according to Thongprasom sign scoring system
Oral Health- Related Quality of Life index (OHIP-14)
Patients were asked to grade the Oral Health- Related Quality of Life index

Secondary Outcome Measures

Oral Hygiene Index
Oral Hygiene Index were evaluated.

Full Information

First Posted
August 25, 2017
Last Updated
May 27, 2020
Sponsor
Bezmialem Vakif University
search

1. Study Identification

Unique Protocol Identification Number
NCT03265093
Brief Title
Use of Injectable Platelet Rich Fibrin in Lichen Planus
Official Title
Current Approach in the Treatment of Lichen Planus: Injectable Platelet Rich Fibrin ((İ-PRF)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
September 2, 2019 (Actual)
Study Completion Date
September 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus
Keywords
Pain Measurement, Platelet Activation, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Blinded, Parallel group, randomized controlled trial
Masking
Investigator
Masking Description
Investigator, Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental; Corticosteroid
Arm Type
Active Comparator
Arm Description
Intralesional corticosteroid administration
Arm Title
Experimental; Injectable Platelet rich fibrin
Arm Type
Experimental
Arm Description
Injectable Platelet rich fibrin
Intervention Type
Other
Intervention Name(s)
Platelet Rich Fibrin Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
Corticosteroid injection
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
6 months
Title
Thongprasom sign scoring system
Description
The lesions were evaluated according to Thongprasom sign scoring system
Time Frame
6 months
Title
Oral Health- Related Quality of Life index (OHIP-14)
Description
Patients were asked to grade the Oral Health- Related Quality of Life index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Oral Hygiene Index
Description
Oral Hygiene Index were evaluated.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Sağlam, PhD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mustafa Tunalı, Assoc. prof.
Organizational Affiliation
Bezmialem VakifUniversity
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tuğba Ünver, PhD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zeliha Betül Özsağır
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ebru SAĞLAM
City
İstanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Use of Injectable Platelet Rich Fibrin in Lichen Planus

We'll reach out to this number within 24 hrs