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临床试验/NCT03011086
NCT03011086已完成不适用

Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis - a Clinico-pathological Study

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Evaluation of auto antibodies in oral sub mucous fibrosis

研究概览

简要总结

The etiology of OSMF is considered to be multifactorial. However, Role of autoimmunity had been suggested as one of the factors but remains unproven.

The present study is undertaken to evaluate the presence of auto antibodies in OSMF patients to pave a way for new arena of treatment with the etiology of this persistent condition

详细描述

Oral submucous fibrosis (OSMF) is a potentially malignant disorder affecting any part of the oral cavity, sometimes pharynx associated with juxta epithelial fibrosis causing progressive trismus leading to dysphagia. It is mainly seen in the Asian countries with more prevalence in India.

Etiology of OSMF is considered to be multifactorial. However, it is strongly associated with the use of arecanut in various forms and also in combination with other compounding factors. Autoimmunity had been suggested as one of the factors yet unproven.

Few studies reveal that there is high incidence of Autoantibodies including antinuclear (ANA), Anti smooth muscle (SMA), Anti thyroid microsomal (TMA), and anti reticulin antibodies in OSMF patients. These findings have not been consistent in further studies which needs further more research in this.

A study concentrated on quantitation of circulating immune complexes (CIC) levels which was established in patients with oral cancer and oral precancerous lesions. The levels were compared with that in normal controls and chronic chewers of betel quid with no signs of any disease. Both patients with oral cancer and oral precancerous lesions had elevated CIC when compared to both the control groups. The most interesting observations were (a) the CIC levels in the chewing controls were significantly raised when compared to normal controls; and (b) the CIC levels in the patients with premalignant lesions were elevated almost to the same levels as in the oral cancer patients.

HLA-typing was carried on areca nut chewers. however, it was unable to demonstrate a specific pattern of HLA-antigen frequencies in chewers with or without the disease. It is not necessarily a HLA-associated susceptibility in Oral Submucous Fibrosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are willing for the study.
  • A positive history of chewing arecanut, and/or smoking tobacco and alcohol.
  • Patients with clinical and histopathological features of oral submucous fibrosis.
  • Patients with OSMF not under any treatment for the same

排除标准

  • Unwilling patients who do not want to be part of the study.
  • Patients with known autoimmune disorders.

结局指标

主要结局

Evaluation of auto antibodies in oral sub mucous fibrosis

时间窗: one and half year

The subjects in the study suffering from oral submucous fibrosis will be clinically evaluated and graded based on criteria given by Khanna et al classification. All the subjects included in the study will also be subjected to serum analysis for presence of auto antibodies in their serum by Titerplane technique.

次要结局

未报告次要终点

研究者

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

NALLAN CHAITANYA

ASSOCIATE PROFESSOR, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

研究点 (1)

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