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CompletedNCT03265093Updated May 28, 2020

Use of Injectable Platelet Rich Fibrin in Lichen Planus

An interventional study of Platelet Rich Fibrin Injection and Corticosteroid in Lichen Planus, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-28.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Lichen Planus

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Keywords

  • Pain Measurement
  • Platelet Activation
  • Quality of Life
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    experimental; Corticosteroid

    Intralesional corticosteroid administration

    Drug: Corticosteroid

  • Experimental
    Experimental; Injectable Platelet rich fibrin

    Injectable Platelet rich fibrin

    Other: Platelet Rich Fibrin Injection

Interventions

  • OtherPlatelet 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.

  • DrugCorticosteroid

    Corticosteroid injection

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. Thongprasom sign scoring system

    The lesions were evaluated according to Thongprasom sign scoring system

    Time frame: 6 months

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

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

    Time frame: 6 months

Secondary outcomes

  1. Oral Hygiene Index

    Oral Hygiene Index were evaluated.

    Time frame: 6 months

06

Study locations

1 site
  • Ebru SAĞLAM
    İstanbul, Fatih 34093, Turkey
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03265093
Lead sponsor
Bezmialem Vakif University
Responsible party
Sponsor
First posted
Aug 29, 2017
Start date
May 3, 2017
Primary completion
Sep 2, 2019
Completion
Sep 2, 2019
Last update
May 28, 2020

Study contacts

Ebru Sağlam, PhD
study chair · Bezmialem Vakif University
Mustafa Tunalı, Assoc. prof.
study director · Bezmialem VakifUniversity
Tuğba Ünver, PhD
principal investigator · Bezmialem Vakif University
Zeliha Betül Özsağır
principal investigator · Bezmialem Vakif University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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