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Efficacy of photobiomodulation on oral lichen planus: a protocol study for a double-blind, randomised controlled clinical trial
  1. Elza Padilha Ferri1,
  2. Camila de Barros Gallo2,
  3. Clery Saad Abboud1,
  4. Wellington Hideaki Yanaguizawa2,
  5. Anna Carolina Ratto Tempestini Horliana1,
  6. Daniela de Fatima Teixeira da Silva1,
  7. Christiane Pavani1,
  8. Sandra Kalil Bussadori1,3,
  9. Fabio Daumas Nunes4,
  10. Raquel Agnelli Mesquita-Ferrari1,3,
  11. Kristianne Porta Santos Fernandes1,
  12. Maria Fernanda Setúbal Destro Rodrigues1
  1. 1 Biophotonics Applied to Health Sciences, Nove de Julho University, São Paulo, Brazil
  2. 2 Department of Stomatology, School of Dentistry, University of São Paulo, São Paulo, Brazil
  3. 3 Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, Brazil
  4. 4 Department of Oral Pathology, School of Dntistry, University of São Paulo, São Paulo, Brazil
  1. Correspondence to Dr Maria Fernanda Setúbal Destro Rodrigues; fernandarodrigues{at}usp.br

Abstract

Introduction Oral lichen planus (OLP) is an idiopathic chronic mucocutaneous disease with a wide range of clinical manifestations, including white reticular patches, erosive/ulcerative and atrophic lesions, both associated with intense symptomatology. Topical corticosteroids are commonly used as standard therapy. However, patients frequently present relapses after the discontinuation of treatment as well as developing resistance to corticosteroid therapy. Photobiomodulation (PBM) has been shown to be a potential therapeutic tool to treat inflammatory disorders, including OLP. The aim of this study was to compare the efficacy of PBM (660 nm) with corticosteroid therapy with clobetasol propionate 0.05% for the treatment of OLP.

Methods and analysis Forty-four patients with symptomatic and histopathological diagnosis of OLP will be randomised into two experimental groups in a double-blind manner: control group (n=22): clobetasol propionate 0.05%+placebo PBM, and experimental group (n=22): PBM (λ=660 nm, power 100 mW, radiant exposure: 177 J/cm2 and 0.5J per point)+placebo gel. Laser will be applied 2×/week for 1 month and clobetasol propionate three times a day for 30 days and the same for placebo treatments. The primary variable (pain) and the secondary variables (clinical score, evaluation of functional scores, clinical resolution, OLP recurrence, quality of life and anxiety and depression) will be evaluated at the baseline, once a week during treatment (depending on the variables) and after 30 days and 60 days of follow-up. Pain will be evaluated using visual analogue scale and clinical characteristics will be scored using the Thongprasom Index. The quality of life and anxiety and depression will be evaluated by Oral Health Impact Profile-14 questionnaire and by Hospital Anxiety and Depression Scale for anxiety scale, respectively. The serum and salivary levels of interleukin (IL)-6, IL-10, IL-1β, INF-γ and tumour necrosis factor-α will be evaluated by ELISA at baseline and at the end of treatment.

Ethics and dissemination This protocol was approved (#2.375.410) by the Nove de Julho University (UNINOVE) Research Ethics Committee. The data gathered using this protocol will be published in a peer-reviewed journal.

Trial registration number NCT03320460.

  • oral lichen planus
  • photobiomodulation
  • corticosteroid
  • clinical response
  • cytokines

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors EPF has made contributions to the acquisition of data, analysis and interpretation of data; CdBG has made contributions to acquisition of data or analysis and interpretation of data and has been involved in drafting the manuscript or revising it critically for important intellectual content. CSA has made contributions to acquisition of data; WHY has been involved in drafting the manuscript or revising it critically for important intellectual content. ACRTH has been involved in drafting the manuscript or revising it critically for important intellectual content; DdFTdS has been involved in drafting the manuscript or revising it critically for important intellectual content; CP, SKB and FDN have given final approval of the version to be published. RAM-F and KPSF have given final approval of the version to be published. MFSDR has made contributions to acquisition of data, or analysis and interpretation of data, has been involved in drafting the manuscript or revising it critically for important intellectual content and has given final approval of the version to be published.

  • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Only principal investigators (authors of this paper) will be given full access to the cleaned data sets. Project data sets will be saved on the computer of Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, R. Vergueiro, 235/249, CEP 01504-001- São Paulo, SP, Brazil, phone: +55 (11) 33859222, and all data sets will be protected by password.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval Research Ethics Committee of Nove de Julho University.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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