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Completed

NCT Number: NCT03293368

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Platelet rich plasma

Biological

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

Triamcinolone Acetonide

Drug

0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa

Other names: Corticosteroids, Steroids

Primary outcomes

  1. Reported Pain

    Time frame: 3 months

    Pain and burning sensation assessed using Numerical rating scale

Secondary outcomes

  1. Clinical score

    Time frame: 3 months

    Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992

  2. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2017
Registry last updated
Feb 9, 2023

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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