Use of Injectable Platelet Rich Fibrin in Lichen Planus

Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265093
• Other study ID #: EbSAGLAM2
• Status: Completed
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: September 2, 2019

Study information

• Verified date: May 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2, 2019
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Planus

Intervention

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

Locations

Country	Name	City	State
Turkey	Ebru SAGLAM	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Thongprasom sign scoring system	The lesions were evaluated according to Thongprasom sign scoring system	6 months
Primary	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	Oral Hygiene Index	Oral Hygiene Index were evaluated.	6 months