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临床试验/NCT06652477
NCT06652477尚未招募不适用

Evaluation of Desmoglein-3 Autoantibodies in the Tissues of Atrophic/Bullous Erosive Oral Lichen Planus and Correlation with Disease Severity

Ain Shams University0 个研究点目标入组 20 人开始时间: 2024年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive oral lichen planus

研究概览

简要总结

  1. evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive (A/BE) OLP (Primary Objective).
  2. correlate the severity of the disease with the level of tissue Dsg3 autoantibodies (Secondary Objective).

详细描述

Oral lichen planus (OLP), a chronic disease and one of the most common dermatoses of the oral mucosa, is characterized by white streaks in a lacelike pattern on the tongue and/or buccal mucosa. The disease is also accompanied by chronic inflammation, the degree of which, correlates with the intensity of the symptoms.

OLP occurs more frequently than the cutaneous form and tends to be more persistent and more resistant to treatment. It affects one to two percent of the general adult population, with a higher prevalence in the female gender, and occurs predominantly in adults over 40, although younger adults and children may be affected .

The most common site of oral involvement is the buccal mucosa followed by the tongue and gingiva, but any site of the oral mucosa can be affected. Clinically, OLP is classified as reticular, atrophic, erosive, plaque-type, and bullous. The reticular pattern is the most common form. It is generally asymptomatic and requires no treatment. In contrast, atrophic-erosive forms usually manifest as erythematous, ulcerative lesions associated with symptoms, fluctuating from mild burning sensation to severe pain, interfering with eating and speaking .

Furthermore, OLP is considered a potentially malignant disorder with a transformation rate of about 1.09%, with greater risk among those with atrophic-erosive forms.

The etiology and pathogenesis of OLP are not completely understood. Several factors have been implicated in the etiology and several hypotheses have been proposed for its pathogenesis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females suffering from A/BE OLP.
  • Proven diagnosis of oral lichen planus based on criteria of WHO (World Health Organization) which is a clinical criteria, clinically proven painful A/BE form of OLP confirmed by the presence of red or erythematous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae).
  • Histopathologically, proven Bullous/erosive or reticular forms of OLP confirmed by the presence of accepted histopathological criteria for lichen planus; basal cell liquefaction, band-like lymphocytic infiltrate at the epithelial-stromal junction with degeneration of basal cell region.

排除标准

  • History of drug-induced lichenoid lesions.
  • Presence of systemic conditions such as serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases.
  • Pregnancy or breastfeeding.
  • History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids, or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study.
  • Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
  • Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
  • Patient refuses to participate in the study.
  • Vulnerable groups (handicapped, orphans, and prisoners).

结局指标

主要结局

evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive oral lichen planus

时间窗: baseline

valuate the level of Dsg3 autoantibodies by ELISA kit trying to elucidate the actual role of Dsg3 autoantibodies in the etiopathogenesis of OLP.

次要结局

  • correlate the severity of the disease with the level of tissue Dsg3 autoantibodies(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa abdelwadood mohamed ibrahim essa

Master's degree student, Faculty of Dentistry, Ain Shams University.

Ain Shams University

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