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OpenTrials
Completed

NCT Number: NCT03265093

Use of Injectable Platelet Rich Fibrin in Lichen Planus

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

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Key information

Conditions

Lichen Planus Lichenoid Eruptions Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ebru SAĞLAM

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Corticosteroid

Drug

Corticosteroid injection

Primary outcomes

  1. Visual Analog Scale

    Time frame: 6 months

    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.

  2. Thongprasom sign scoring system

    Time frame: 6 months

    The lesions were evaluated according to Thongprasom sign scoring system

  3. Oral Health- Related Quality of Life index (OHIP-14)

    Time frame: 6 months

    Patients were asked to grade the Oral Health- Related Quality of Life index

Secondary outcomes

  1. Oral Hygiene Index

    Time frame: 6 months

    Oral Hygiene Index were evaluated.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2017
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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