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临床试验/NCT07381595
NCT07381595尚未招募不适用

Impact of Subgingival Instrumentation on Clinical and Immunohistochemical Presentation of Oral Lichen Planus With Gingival Involvement

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Change in clinical signs and symptoms in cases of oral lichen planus

研究概览

简要总结

The goal of this interventional study is to assess the clinical and histopathological changes in Oral Lichen Planus patients with gingival involvement pre and post subgingival instrumentation.

Objective- Primary objective: To observe and evaluate the clinical signs and symptoms in Oral Lichen Planus with gingival involvement. Secondary objective: To observe and evaluate the Cluster of Differentiation (CD) 4+ and 8+T lymphocytes in Oral Lichen Planus with gingival involvement.

Study group: 30 cases of Oral Lichen Planus with gingival involvement

详细描述

Title: Impact of subgingival instrumentation on clinical and immunohistochemical presentation of Oral Lichen Planus with gingival involvement.

It aims to answer whether subgingival instrumentation will lead to a reduction in clinical signs and symptoms, as well as a decrease in the immunohistochemical expression of Cluster of Differentiation (CD) 4+ and CD8+T lymphocytes. P-(Population)- Oral Lichen Planus patients with gingival involvement. I (Intervention)- Root planing and scaling. C (Comparison)- Same cases after 4 weeks. O (Outcome)- Assessment of clinical symptoms, pain and gingival index at baseline and after 4 weeks. Quantitative assessment of CD4+ and CD8+T lymphocytes at baseline and after 4 weeks.

Periodontitis is an irreversible plaque-induced microbial disease that leads to the destruction of the periodontal ligament and alveolar bone. Its etiopathogenesis is multifactorial and controversial. Oral lichen planus is a T-cell mediated chronic mucocutaneous disease of unknown etiology with an impact of 0.1-4% of the general adult population. Despite various pharmacological advances, the medical management of oral lichen planus remains a daunting task. This could be attributed to the fact that the etiopathogenesis of this disease remains unascertained. Recent evidence does show interactions between these two diseases, where some researchers found that periodontal status in oral lichen planus cases was significantly worse than in healthy controls. Other reports stated that in gingival atrophic-erosive-type oral lichen planus lesions, there was a significant increase in dental plaque and calculus deposits, associated with a higher incidence of periodontal deterioration. Cumulative evidence supports the role of immune dysregulation mediated by the release of cytokines by activated T cells. There is evidence that effective plaque control diminishes the gingival lesions of oral lichen planus, which could be improved by the maintenance of proper oral hygiene and periodontal treatment. However, whether this change in symptoms also makes any histological difference is yet to be known.

To date, no study has evaluated the role of T lymphocytes (CD 8+ cytotoxic & 4+ helper) pre and post scaling and root planing in cases of oral lichen planus with gingival involvement. This study was conceived to evaluate the change in clinical signs and symptoms in oral lichen planus with gingival involvement, as well as a reduction in the number of CD4+ and CD8+T lymphocytes pre and post-treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Clinically and histopathologically confirmed cases of OLP.
  • OLP predominantly involving the gingiva.
  • Consent obtained.

排除标准

  • Cases which does not fulfil either clinical or histopathological criteria.
  • Unwilling to participate in the study.
  • Patients with recorded history of factors that might modify immune response (such as patient on corticosteroids or medically compromised patients or suffering from heart diseases).
  • Cases undergoing treatment of OLP within past 6 months.
  • Biopsies with inadequate or non-representative samples
  • Cases histopathologically diagnosed as Lichenoid Dysplasia or Oral Lichenoid Lesions.
  • Cases diagnosed with autoimmune disorders.

研究组 & 干预措施

Oral Lichen Planus

Experimental

Scaling and root planing will be conducted on Oral Lichen Planus cases with gingival involvement.

干预措施: subgingival instrumentation (Procedure)

结局指标

主要结局

Change in clinical signs and symptoms in cases of oral lichen planus

时间窗: At baseline and after end of treatment at 4 weeks

Clinical signs and symptoms will be recorded using oral disease severity score criteria

次要结局

  • Change in the number of CD4+ and CD8+T lymphocyte count pre and post-treatment in cases of oral lichen planus(At baseline and after end of treatment at 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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