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临床试验/NCT07597616
NCT07597616尚未招募不适用

Studio Retrospettivo Monocentrico di Una Coorte di Pazienti Affetti da Lichen Planus Orale: Caratteristiche, comorbilità e Fattori di Rischio Per la Trasformazione Maligna

Catholic University of the Sacred Heart0 个研究点目标入组 176 人开始时间: 2026年5月20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
176

研究概览

简要总结

This case-control study will enroll 176 patients age- and sex- matched at the Oral Medicine Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. There will be two groups: The control group will consist of 88 healthy patients enrolled among those routinely attending the dental outpatient clinic. An additional 88 patients diagnosed with OLP will form the case group. Both groups will undergo standard dental examinations, including periodontal probing. The primary objective is to evaluate whether patients with OLP present a higher prevalence and severity of periodontitis compared to healthy subjects. Secondary objectives include the assessment of gingivitis prevalence and RT1 gingival recessions in OLP patients compared with controls. Periodontal status will be assessed using major clinical indices and classified according to the 2017 AAP/EFP case definition. The study aims to contribute evidence on the shared immune-inflammatory mechanisms underlying both conditions, with potential clinical implications for the integrated periodontal management of OLP patients.

研究设计

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

入排标准

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

入选标准

  • OLP group (case)
  • Age ≥ 18 years Clinical and histopathological diagnosis of OLP according to WHO criteria (2021)
  • Control group
  • Age ≥ 18 years Absence of clinical signs of OLP

排除标准

  • Both groups
  • Oral lichenoid lesions (OLL): oral lichenoid contact reactions (OLCR), lichenoid drug reactions (LDR), lesions associated with food/substances (e.g. cinnamon) Oral lesions associated with graft-versus-host disease (GVHD) History of haematopoietic stem cell transplantation (HSCT) Pregnancy Oncologic patients (including oral cancers) Smokers Diabetes mellitus Obesity Metabolic syndrome Immunosuppressive therapy Medications causing gingival hyperplasia
  • Control group only
  • Immune-mediated inflammatory diseases with oral involvement (e.g. psoriasis, systemic or discoid lupus erythematosus) Autoimmune oral diseases other than OLP
  • OLP group only
  • Immunosuppressive therapy for conditions other than OLP Autoimmune oral diseases other than OLP

研究组 & 干预措施

Cohort of healthy subject

Cohort of subjects diagnosed with Oral Lichen Planus

研究者

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

Carlo Lajolo

Prof.

Catholic University of the Sacred Heart

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