Use of Injectable Platelet Rich Fibrin in Lichen Planus

NCT ID: NCT03265093

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-03
• Study Completion Date: 2019-09-02

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.

Conditions

Lichen Planus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

experimental; Corticosteroid

Intralesional corticosteroid administration

Group Type: ACTIVE_COMPARATOR

Corticosteroid

Intervention Type: DRUG

Corticosteroid injection

Experimental; Injectable Platelet rich fibrin

Injectable Platelet rich fibrin

Group Type: EXPERIMENTAL

Platelet Rich Fibrin Injection

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Corticosteroid

Corticosteroid injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ebru Sağlam, PhD

Role: STUDY_CHAIR

Bezmialem Vakif University

Mustafa Tunalı, Assoc. prof.

Role: STUDY_DIRECTOR

Bezmialem VakifUniversity

Tuğba Ünver, PhD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Zeliha Betül Özsağır

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Ebru SAĞLAM

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

EbSAGLAM2

Identifier Type: -

Identifier Source: org_study_id