Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus

February 7, 2023 updated by: Abdelhameed Hamid Mohammad Hijazi, Cairo University

Efficacy of Intralesional Injection of Autologous Platelet Rich Plasma Versus Intralesional Injection of Corticosteroids on Pain Relief and Ulcers Healing in Patients With Erosive Oral Lichen Planus; Randomized Clinical Trial

After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant in the intervention group will receive intralesional injections of platelet rich plasma extracted from their own blood in each visit as following:

  1. 12 ml of blood will be assembled from the veins of antecubital fossa
  2. PRP preparation will be done according to Mostafa et al., 2013
  3. 0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa

The second group will receive triamcinolone acetonide 40 mg injected 1 ml per 1 cm2 of ulcerated mucosa

Both groups will receive a total of 4 injection, the injections will be carried out once a week.

Pain, lesions size and remission time are the outcomes will be assessed using a numerical rating scale (Seymour, 1982), clinical score according to Thongprasom et al., 1992 and binary scale for remission time according to Conrotto et al., 2006, respectively.

Assessment of the outcomes will be carried before the trial (baseline records) and before receiving the treatment in each visit by the primary investigator (H.A.) and the blinded assessor (Dr. A.W.) separately.

Each participant will have a total of 11 visits during the trial, 5 visits will be once every week during the trial and every 2 weeks for 3 months treatment free.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting with a clinical picture that assumes the diagnosis of erosive oral lichen planus (bilateral, more or less symmetrical erosive lesions with lacelike network of slightly raised gray white lesions (reticular pattern), and a histological findings that confirms the diagnosis (liquefaction degeneration of the basal cell layer with irregular-saw teeth like rete pegs.

Exclusion Criteria:

  • Systemic disorders such as hematological diseases, severe cardiovascular diseases, treatment with any drugs that could cause Lichenoid reaction.
  • Pregnancy or active breastfeeding
  • Patients who had lesion/lesions with dysplasia
  • Patients who received topical treatment for Oral Lichen planus in the last 2 weeks (Lee et al., 2013) or systemic treatment for OLP in the past 3 months.
  • Platelet count < 150,000/mm3; Hgb < 11 g/dl.
  • Immunosuppressed patients
  • Patients receiving therapy with anticoagulants and use of non-steroidal anti-inflammatory drugs in the 5 days before taking the blood sample.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Platelet rich plasma
0.5 ml of autologous platelet rich plasma prepared using a double spin technique described by Mostafa et al., 2013 will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.
Biological: Platelet rich plasma
Platelet rich plasma will be prepared from the patients own blood in the same visit using a double spin technique, then 0.5 ml of PRP will be injected per 1 cm2 of eroded oral mucosa.
Other Names:
  • Platelet rich in growth factors
ACTIVE_COMPARATOR: Croticosteroids
0.5 ml of triamcinolone acetonide 40 mg will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.
Drug: Triamcinolone Acetonide
0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa
Other Names:
  • Corticosteroids, Steroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reported Pain
Time Frame: 3 months
Pain and burning sensation assessed using Numerical rating scale
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical score
Time Frame: 3 months
Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992
3 months
Remission time
Time Frame: 3 months
Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

January 1, 2021

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (ACTUAL)

September 26, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP-olp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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