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Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial.

ABSTRACT: Objective: To evaluate the efficacy of photodynamic therapy (PDT) and photobiomodulation (PBM) in the treatment of oral lichen planus (OLP) in comparison with the use of topical corticosteroids. Material and methods: Sixty patients with OLP were randomized to three groups: group 1 photodynamic therapy applied once a week for four sessions, with orabase cream; group 2 low-power laser application with orabase cream; and group 3 inactive laser with triamcinolone acetonide 0.1%. Patient pain was evaluated, and the Thongprasom severity score, the Oral Health Impact Profile-14 (OHIP-14), and the Hamilton anxiety and depression scale at one and three months of follow-up. (ClinicalTrials.gov Identifier: NCT05127083). Results: Pain decreased significantly over time in all groups, though the symptoms relapsed over follow-up at one and three months in group 3. The OHIP-14 score improved significantly in groups 1 and 2 (p < 0.05), and this improvement was maintained after three months. Lesion resolution evaluated by the Thongprasom score at one month showed significant differences between groups 1 and 3 (p = 0.032) and between groups 2 and 3 (p = 0.024). Conclusions: Photodynamic therapy and photobiomodulation once a week for four weeks are safe and non-invasive treatment options, with the important advantage of lacking adverse effects. Further studies are needed to confirm it.

SUBMITTER: Salinas-Gilabert C

PROVIDER: S-EPMC9862179 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial.

Salinas-Gilabert Carmen C Gómez García Francisco F Galera Molero Fe F Pons-Fuster Eduardo E Vander Beken Seppe S Lopez Jornet Pia P

Pharmaceutics 20221222 1

Objective: To evaluate the efficacy of photodynamic therapy (PDT) and photobiomodulation (PBM) in the treatment of oral lichen planus (OLP) in comparison with the use of topical corticosteroids. Material and methods: Sixty patients with OLP were randomized to three groups: group 1 photodynamic therapy applied once a week for four sessions, with orabase cream; group 2 low-power laser application with orabase cream; and group 3 inactive laser with triamcinolone acetonide 0.1%. Patient pain was eva ...[more]

PMID: 36678659

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Project description:ImportanceSymptomatic oral lichen planus (OLP) can be challenging to treat.ObjectiveTo compare the efficacy of oral acitretin plus topical triamcinolone acetonide (TAC), 0.1%, with TAC monotherapy in patients with symptomatic OLP.Design, setting, and participantsThis monocentric, investigator-initiated, placebo-controlled, investigator- and patient-blinded randomized clinical trial was conducted from December 2018 to June 2020 at the Postgraduate Institute of Medical Education and Research, a tertiary referral center in Chandigarh, India. Sixty-four patients 18 years or older with symptomatic OLP were recruited by consecutive sampling. Data were analyzed from July to December 2020.InterventionThe patients were randomized to receive either a combination of oral acitretin (25-35 mg/d) and TAC (treatment group) or TAC in combination with placebo (placebo group) for 28 weeks, with an additional 8 weeks of treatment-free follow-up after the end of treatment (36 weeks of total study duration).Main outcomes and measuresThe disease severity and treatment response were assessed using Oral Disease Severity Score (ODSS), Oral Health Impact Profile 14 (OHIP-14), and visual analog scale (VAS). The primary aim was to assess the number of patients achieving ODSS-75 (75% reduction in ODSS compared with baseline) in both groups at 28 weeks and at the end of 36 weeks.ResultsAmong 64 patients, 31 in the treatment group and 30 in the placebo group completed the study (mean [SD] age, 50.6 [15.2] years vs 49.2 [14.4] years; male-female ratio, 13:19 vs 16:16). Baseline ODSS, visual analog scale, and Oral Health Impact Profile 14 scores were comparable in both groups. In the intention-to-treat analysis, there was a statistically significant higher number of patients achieving 75% or higher reduction in ODSS in the treatment group compared with the placebo group at the end of 28 weeks (28 [88%] vs 15 [47%], a 41 [95% CI, 20-61] percentage point difference between groups; P < .001; Cramér V = 0.47) and 36 weeks (27 [84%] vs 13 [41%], a 43 [95% CI, 23-67] percentage point difference between groups; P < .001; Cramér V = 0.47). Relapses during the posttreatment follow-up of 8 weeks were low among patients in both treatment and placebo groups (1 [3%] vs 2 [6%], a 3 [95% CI, -13 to 7] percentage point difference between groups; P > .99; Cramér V = 0.07).Conclusion and relevanceIn this randomized clinical trial, the combination of oral acitretin and TAC was more effective than TAC monotherapy in patients with symptomatic OLP.Trial registrationClinical Trial Registry of India Identifier: CTRI/2018/11/016448.

Project description:BackgroundOral lichen planus (OLP) is a chronic illness of immune origin that is typically treated with corticosteroids as a gold standard therapy. Photobiomodulation (PBM) may represent an alternative remedy that has the potential to treat a variety of pathological conditions by alleviating pain, reducing inflammation, and promoting tissue healing without the drawbacks of steroid therapies. Thus, the aim of the current study was to compare the effect of photobiomodulation to topical 0.1% triamcinolone acetonide on erosive oral lichen planus.MethodsThis randomized controlled clinical trial involved 44 patients complaining of erosive oral lichen planus. Patients were assigned to one of two groups: control group (n = 22) received 0.1% topical triamcinolone acetonide three times daily with miconazole oral gel once daily for 4 weeks, and photobiomodulation group (n = 22) received laser therapy by 980 nm diode laser utilizing output power 300 mW twice weekly for 5 weeks (a total of 10 sessions). The evaluation of patients was performed at baseline, 6 weeks, and 12 weeks postoperatively in terms of pain, clinical scores, and biochemical evaluation of salivary malondialdehyde levels. All recorded data were analyzed using Mann-Whitney test to compare the two studied groups regarding pain, lesion size, and salivary levels of malondialdehyde. Friedman test, followed by post hoc test, was used for comparison of the data within the same group along the 3 periods at baseline, 6 weeks, and 12 weeks.ResultsBoth groups showed significant improvement in pain and clinical scores, with no statistical difference between them. Moreover, there was a significant improvement in salivary malondialdehyde levels for both groups, with no significant difference between them.ConclusionsPhotobiomodulation could be a promising therapeutic modality for management of erosive oral lichen planus without the side effects of steroid therapy. The salivary malondialdehyde level could be used as a biomarker to evaluate the disease severity and its response to the treatment.Trial registrationThe study has been registered at ClinicalTrials.gov (NCT05951361) (19/07/2023).

Project description:IntroductionOral 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 analysisForty-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 disseminationThis 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 numberNCT03320460.

Dataset Information

Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial.

Publications

Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial.

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