Use of Injectable Platelet Rich Fibrin in Lichen Planus

NCT03265093 | Completed DMC

• 1 other identifier: EbSAGLAM2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Lichen Planus

Keywords

Pain Measurement; Platelet Activation; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Oral Hygiene Index

  6 months

Study Arms (2)

experimental; Corticosteroid

ACTIVE COMPARATOR

Intralesional corticosteroid administration

Drug: Corticosteroid

Experimental; Injectable Platelet rich fibrin

EXPERIMENTAL

Injectable Platelet rich fibrin

Other: Platelet Rich Fibrin Injection

Interventions

Platelet Rich Fibrin Injection 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.

Experimental; Injectable Platelet rich fibrin

Corticosteroid DRUG

Corticosteroid injection

experimental; Corticosteroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Ebru SAĞLAM

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lichen Planus

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ebru Sağlam, PhD

  Bezmialem Vakif University

  STUDY CHAIR

• Mustafa Tunalı, Assoc. prof.

  Bezmialem VakifUniversity

  STUDY DIRECTOR

• Tuğba Ünver, PhD

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

• Zeliha Betül Özsağır

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator, Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded, Parallel group, randomized controlled trial

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Study Start: May 3, 2017
• Primary Completion: September 2, 2019
• Study Completion: September 2, 2019
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

TU (1)