Clinical trial NCT03320460: Photobiomodulation in Oral Lichen Planus
Official title: Efficacy of Photobiomodulation for Oral Lichen Planus Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lichen Planus, Oral
Low-Level Light Therapy
Keywords: oral lichen planus; photobiomodulation; inflammation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group Experimental Group
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the efficacy of PBM (660nm) and corticosteroid therapy with clobetasol propionate 0.05% in the treatment of OLP. This is a protocol for a randomized, controlled, double blind clinical trial. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% for 30 consecutive days and with placebo PBM twice a week. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive PBM twice a week during 1 month (laser λ = 660±10 nm; power 100mW; radiant energy 177J/cm2; 5-s exposure time per point and 0.5J of energy per point. The primary variable (pain) and the secondary variables including clinical scores and functional scores as well as patient anxiety and depression (The Hospital Anxiety and Depression Scale-HADS), will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p \< 0.05).

Detailed description: Oral lichen planus is an idiopathic chronic mucocutaneous disease with a ride range of clinical manifestations, including white reticular patches, erosive/ulcerative and atrophic lesions, both associated with intense symptomatology. CD4+ and CD8+ T lymphocytes cells play an important role in the pathogenesis of OLP and are responsible for the production of different cytokines, including IL-6, IL-10, IL-1β, INF-γ and TNF-α. Treatment is symptomatic and topical corticosteroids are commonly used as standard therapy. However, patients frequently present relapses after treatment's discontinuation, develop resistance to corticosteroids therapy as well as secondary candidiasis. Photobiomodulation (PBM) has shown to be a potential therapeutic tool to treat inflammatory disorders, including OLP. Some studies have demonstrated that PBM improves the clinical presentation of OLP (erosive/ulcerative or atrophic lesions to reticular lesions), reduces pain and recurrence. However, it remains controversy if PBM is more effective than corticosteroid in the treatment of OLP. The aim of this study is to evaluate the efficacy of PBM in the treatment of OLP in relation to the standard therapy with corticosteroids. This is a protocol for a randomized, controlled, doubled blind clinical trial, with two months of follow up.

Patients with symptomatic OLP and with histopathological diagnosis of OLP based on WHO criteria will be included in this study. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% gel for 30 consecutive days and the laser device will be positioned over the lesion but will be switched off to mask the treatment. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive laser treatment twice a week during 1 month for PBM (laser λ = 660±10 nm; power 100mW; radiant energy; 177J/cm2; 5-s exposure time per point and 0.5J of energy per point). The primary variable (pain by VAS scale) and the secondary variables (clinical scores, functional scores and Patient anxiety and depression) will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The findings will be computed and submitted to statistical analysis. Interval estimates will be used for the variables of interest to determine the prevision of the estimates and perform comparisons. If necessary, transformation methods or non-parametric tests will be applied. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p \< 0.05).

Eligibility criteria: Inclusion Criteria:

* The participants in this study will be male and female (aged over 18 years) diagnosed with symptomatic oral lichen planus, based on the clinical and histopathological criteria of the World Health Organization (WHO).

Exclusion Criteria:

* Patients with ongoing cancer; pregnant or breastfeeding women; patients with history of corticosteroids and nonsteroidal anti-inflammatory treatment in the last one months, patients with uncontrolled systemic disease; consumption of illicit drugs; use of medication associated with oral lichenoid reactions; amalgam restoration near to OLP lesions; epithelial dysplasia in the histopathological examination.

Primary outcomes:
measure: Assessment of Pain of OLP
timeFrame: Participants will be evaluated at baseline (Day 0)
measure: Assessment of Pain of OLP
timeFrame: Participants will be evaluated after 1 week of treatment (Day 7)
measure: Assessment of Pain of OLP
timeFrame: Participants will be evaluated after 2 weeks of treatment (Day 14)
measure: Assessment of Pain of OLP
timeFrame: Participants will be evaluated after 3 weeks of treatment (Day 21)
measure: Assessment of Pain of OLP
timeFrame: Participants will be evaluated after 4 weeks of treatment (Day 30)
measure: Assessment of Pain of OLP
timeFrame: 30 days after the discontinuation of treatment (follow-up period)
measure: Assessment of Pain of OLP
timeFrame: 60 days after the discontinuation of treatment (follow-up period)
Secondary outcomes:
measure: Assessment of clinical presentation of OLP
timeFrame: Participants will be evaluated at baseline (Day 0)
measure: Assessment of clinical presentation of OLP
timeFrame: Participants will be evaluated after 1 week of treatment (Day 7)
measure: Assessment of clinical presentation of OLP
timeFrame: Participants will be evaluated after 2 weeks of treatment (Day 14)
measure: Assessment of clinical presentation of OLP
timeFrame: Participants will be evaluated after 3 weeks of treatment (Day 21)
measure: Assessment of clinical presentation of OLP
timeFrame: Participants will be evaluated after 4 weeks of treatment (Day 30)
measure: Assessment of clinical presentation of OLP
timeFrame: 30 days after the discontinuation of treatment (follow-up period)
measure: Assessment of clinical presentation of OLP
timeFrame: 60 days after the discontinuation of treatment (follow-up period)
measure: Function
timeFrame: Participants will be evaluated at baseline (Day 0)
measure: Function
timeFrame: Participants will be evaluated after 1 week of treatment (Day 7)
measure: Function
timeFrame: Participants will be evaluated after 2 weeks of treatment (Day 14)
measure: Function
timeFrame: Participants will be evaluated after 3 weeks of treatment (Day 21)
measure: Function
timeFrame: Participants will be evaluated after 4 weeks of treatment (Day 30)
measure: Function
timeFrame: 30 days after the discontinuation of treatment (follow-up period)
measure: Function
timeFrame: 60 days after the discontinuation of treatment (follow-up period)
measure: Clinical Resolution
timeFrame: Participants will be evaluated after 4 weeks of treatment (Day 30)
measure: Recurrence rate
timeFrame: The recurrence rate will be evaluated 30 days after the discontinuation of treatment (follow-up period)
measure: Recurrence rate
timeFrame: The recurrence rate will be evaluated 60 days after the discontinuation of treatment (follow-up period)
measure: Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
timeFrame: Baseline (day 0)
measure: Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
timeFrame: After 4 weeks of treatment (Day 30)
measure: Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
timeFrame: Baseline (Day 0)
measure: Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
timeFrame: After 4 weeks of treatment (Day 30)
measure: Assessment of Quality of life in OLP patients
timeFrame: Baseline (Day 0)
measure: Assessment of Quality of life in OLP patients
timeFrame: After 4 weeks of treatment (Day 30)
measure: Assessment of Quality of life in OLP patients
timeFrame: 30 days after the discontinuation of treatment (follow-up period)
measure: Assessment of Quality of lifein OLP patients
timeFrame: 60 days after the discontinuation of treatment (follow-up period)
measure: Anxiety and Depression
timeFrame: Baseline (Day 0)
measure: Anxiety and Depression
timeFrame: Participants will be evaluated after 1 week of treatment (Day 7)
measure: Anxiety and Depression
timeFrame: Participants will be evaluated after 2 weeks of treatment (Day 14)
measure: Anxiety and Depression
timeFrame: Participants will be evaluated after 3 weeks of treatment (Day 21)
measure: Anxiety and Depression
timeFrame: Participants will be evaluated after 4 weeks of treatment (Day 30)
measure: Anxiety and Depression
timeFrame: 30 days after the discontinuation of treatment (follow-up period)
measure: Anxiety and Depression
timeFrame: 60 days after the discontinuation of treatment (follow-up period)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Scholl of Dentistry, University of São Paulo
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Maria Fernanda SD Rodrigues, PhD
role: PRINCIPAL_INVESTIGATOR
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