Efficacy of injectable PRGF in the treatment of the erosive oral lichen planus: a split - mouth, randomized, controlled clinical trial

Abstract

Cilj istraživanja: Usporediti učinkovitost primjene plazme bogate faktorima rasta (PRGF) kao potencijalne metode liječenja erozivnog oralnog lichen planusa (EOLP) s topikalnom primjenom kortikosteroida koja predstavlja trenutni zlatni standard u liječenju ove bolesti. Materijali i metode: U studiju su bili uključeni pacijenti kojima je biopsijom potvrđena dijagnoza EOLP-a. Pacijenti koji su zadovoljili sve kriterije i odlučili sudjelovati, potpisali su suglasnost. Istraživanje smo proveli kao split- mouth kontroliranu studiju. U jednoj polovici usne šupljine primijenili smo PRGF, a u drugoj kortikosteroid kao zlatni stanard u terapiji. Randomizaciju smo proveli metodom slučajnog odabira. Radili smo četiri aplikacije svakih sedam dana kroz četiri tjedna zaredom te potom kontrolne preglede u četiri vremenske točke (7, 30, 60 i 90 dana nakon zadnje aplikacije). Prilikom svakog posjeta određivali smo veličinu lezija, radili kliničke fotografije prije svake primjene te zatražili pacijenta da ocijeni subjektivne simptome boli i pečenja za svaku stranu usne šupljine prema VAS-i. Također, pacijenti su ispunili OHIP-14 upitnik pri prvoj aplikaciji te prvoj i četvrtoj kontrolnoj posjeti. Rezultati: Ova split-mouth studija je provedena na 15 ispitanika. Uspoređivane su razine boli i pečenja za svaku grupu pojedinačno te između grupa. Dokazano je kako između grupa nema statistički značajne razlike dok je unutar grupa dokazana statistički značajna razlika između dolazaka. Veličina lezija se u obje grupe kontinuirano smanjivala te je također dokazano kako nema statistički značajne razlike između grupa. Dinamika OHIP-14 zbira kontinuriano se smanjivala između triju točaka mjerenja. Zaključci: Primjena PRGF- a kao i kortikosteroida dovela je do značajnog smanjenja boli, pečenja i veličine lezija kao i do poboljšanja kvalitete života. Dokazano je kako nema statistički značajne razlike između grupa te nisu zabilježene nikakve nuspojave nakon terapijske aplikacije PRGF-a. Potrebna su daljnja istraživanja kako bi se potvrdili dobiveni rezultati, ali PRGF se može razmatrati kao alternativna metoda u liječenju EOLP- a.Research objective: Comparing the efficacy of using growth factor rich plasma (PRGF) as a potential method for treating erosive oral lichen planus (EOLP) to the topical use of corticosteroids, which is the current gold standard when it comes to treating this disease. Materials and methods: This study included patients with biopsy- confirmed EOLP diagnosis. Patients that fit all of the criteria and decided to participate in the study signed the consent forms. The research was conducted as a split-mouth control study. One half of the oral cavity was treated using PRGF, and the other used corticosteroids which is the golden standard in therapy. Randomization was conducted by the random selection method. The therapy was applied four times, every seven days over the course of four weeks, with control examinations at four different points in time (7, 30, 60 and 90 days after the last application). During each of the visits, we determined the size of the lesions, made clinical photographs before each application, and asked the patients to grade their subjective pain symptoms and burning sensation using the VAS (visual analog scale) for each side of the oral cavity. Patients also filled out the OHIP-14 questionnaire before the first application and during the first and fourth control visit. Results: This split-mouth study has been conducted on 15 patients by comparing different levels of pain and the burning sensation for each group individually and among different groups. It has been proven that there are no statistically significant differences between the groups but there are statistically significant differences between different sessions inside the same group. In both groups, lesion size had been continuously decreasing and it was proven that there were no statistically significant differences between the groups. The dynamics of OHIP-14 sum had been continuously decreasing between the three measurement points. Conclusion: Using the PRGF method, as well as the use of corticosteroids brought a significant decrease of pain levels and the burning sensation, decrease in lesion size and an improved quality of life. It was proven that there are no statistically significant difference between the groups and there was no noted side effects after the therapeutic application of PRGF. Additional research is needed to confirm the results, but the PRGF can be considered as an alternative method in treating EOLP