Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis

Study Overview
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Brief Summary
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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

Detailed Description
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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. Due to less number of articles published on autoantibodies, this study is done to evaluate the presence of such auto antibodies in OSMF patients thereby paving way for new arena of treatment on par with the etiology of this persistent condition.

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

Conditions
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Oral Submucous Fibrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unwilling patients who do not want to be part of the study. Patients with known autoimmune disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| oral sub mucous fibrosis<br>patients suffering with oral sub mucous fibrosis due to gutka/pan chewing confirmed by clinical examination | |
| control group<br>patients having gutka/ pan chewing habit without oral sub mucous fibrosis in oral cavity | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of auto antibodies in oral sub mucous fibrosis | 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. | one and half year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autoantibodies, Oral Submucous Fibrosis