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

NCT03293368 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-02-09

No results posted yet for this study

Summary

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.

Conditions

  • Erosive Oral Lichen Planus

Interventions

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.

DRUG

Triamcinolone Acetonide

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Soheir Gaafar, Professor · Professor of oral medicine, diagnosis and periodontology. Faculty of Dentistry. Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-01-01
Completion
2021-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03293368 on ClinicalTrials.gov