Dataset Information

Efficacy of photobiomodulation on oral lichen planus: a protocol study for a double-blind, randomised controlled clinical trial.

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 (?=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-1?, INF-? and tumour necrosis factor-? 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.

SUBMITTER: Ferri EP

PROVIDER: S-EPMC6194464 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy of photobiomodulation on oral lichen planus: a protocol study for a double-blind, randomised controlled clinical trial.

Ferri Elza Padilha EP Gallo Camila de Barros CB Abboud Clery Saad CS Yanaguizawa Wellington Hideaki WH Horliana Anna Carolina Ratto Tempestini ACRT Silva Daniela de Fatima Teixeira da DFTD Pavani Christiane C Bussadori Sandra Kalil SK Nunes Fabio Daumas FD Mesquita-Ferrari Raquel Agnelli RA Fernandes Kristianne Porta Santos KPS Rodrigues Maria Fernanda Setúbal Destro MFSD

BMJ open 20181008 10

<h4>Introduction</h4>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 bee ...[more]

PMID: 30297352

Similar Datasets

Project description:IntroductionPhotobiomodulation (PBM) has been suggested as an alternative treatment for melasma. In vitro studies have shown PBM with amber light inhibits the tyrosinase enzyme, induces autophagy and reduces the melanin content, but randomised controlled clinical trials are still needed. This study aims to evaluate the efficacy of amber PBM (590 nm) in the treatment of melasma compared with liposomal tranexamic acid.Methods and analysisThis study is a controlled, randomised, double-blind, non-inferiority trial. This study will be performed in two centres (Universidade Nove de Julho Facility, Campus Vergueiro, and Galache Odontology Clinic, São Caetano do Sul, both in São Paulo State, Brazil). The sample (54 participants) will be divided into two groups in a 1:1 ratio; one group will receive active PBM and a placebo cosmetic and the other will receive sham PBM and liposomal tranexamic acid. Women presenting facial melasma, aged 35-50 years, with skin phototypes II-IV, will be eligible for inclusion. Women who use oral contraceptives, intrauterine devices, hormone replacement or photosensitive drugs, those with autoimmune disease and those who have undergone facial treatments in the last 3 months will be excluded from the study. The participants will receive PBM weekly for 12 weeks and will use the cosmetic two times per day at home during this period. The severity of melasma will be evaluated through the Melasma Area and Severity Index (MASI) as the primary outcome; pigmentation of the epidermis evaluated by corneomelametry, the photographic records, the global diagnosis of the face and the quality-of-life questionnaire (Brazilian Portuguese version of the Melasma Quality of Life Questionnaire) will assessed as secondary outcomes. All assessments will be made before starting the study (week 0), mid-study at 6 weeks and at the completion of treatment (week 12). MASI will also be evaluated during follow-up (weeks 16 and 20). The data will be analysed based on the intention-to-treat analysis using a generalised mixed model, and α <0.05 will be considered statistically significant.Ethics and disseminationThe protocol was approved by the Research Ethics Committee of Universidade Nove de Julho (5 332 384). All participants will fill out the patient informed consent form. The results obtained in this trial will be presented at conferences and submitted for publication.Trial registration numberClinicalTrials.gov Registry (NCT05326997).

Project description:IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10-20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

Project description:BackgroundOral lichen planus (OLP) is a mucocutaneous autoimmune disease with T-cell mediation. Corticosteroids are considered as a first choice in OLP and should be used for a long period with a subsequent increase in dose since the disease has a chronic and recalcitrant nature. There have been efforts to use alternative therapies due to the Corticosteroid's side effects. Curcumin is a non-toxic natural product with different effects on various oral diseases. It demonstrates antioxidant, anti-inflammatory, antimicrobial, and anticarcinogenic activities. It seems that Curcumin can be used as a proper alternative for Corticosteroid treatments. To overcome limitations in the bioavailability of Curcumin, the therapeutic effect of oral Nano-Curcumin was evaluated for the first time.MethodsSixty OLP patients were included in this double-blinded randomized clinical trial. The patients were randomly divided into two groups and received either 'Nano-Curcumin 80 mg' or 'Prednisolone 10 mg' treatments for 1?month. The patients should take one capsule after having their breakfast. The VAS scale was used to analyze pain severity and burning sensation. To assess lesion size the Thongprasom scale was employed. Repeated measures and independent t-tests, as well as LSD paired-test, were used to analyze the data.ResultsData from 57 patients were analyzed. The level of pain, burning sensation, and OLP lesions decreased in both groups of Curcumin and Prednisolone and no statistically significant difference was observed between the two groups.ConclusionDespite many studies conducted to find an effective approach for managing OLP, the results have often been unsatisfactory. In comparison with previous studies, current results clarify the importance of Nano-Curcumin bioavailability in therapeutic effects. Pain VAS and lesion size were decreased with oral Curcumin. The results have shown that oral Curcumin can be used as an alternative therapy for OLP in patients with the contraindicated Corticosteroids or should be used with caution. Oral Curcumin can be used in preventing the recurrence of OLP lesions after the treatment and initial control. Moreover, the amount of Curcumin dose is more important than its use duration in improving OLP.Trial registrationIRCT, IRCT20100101002950N5. Registered 9 February 2019, https://www.irct.ir/trial/36704 .

Dataset Information

Efficacy of photobiomodulation on oral lichen planus: a protocol study for a double-blind, randomised controlled clinical trial.

Publications

Efficacy of photobiomodulation on oral lichen planus: a protocol study for a double-blind, randomised controlled clinical trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets