Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis

Oral Submucous Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011086
• Other study ID #: PMVIDS/OMR/0016/2014
• Status: Completed
• Phase: N/A
• First received: November 7, 2016
• Last updated: December 18, 2017
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Oral Submucous Fibrosis

Locations

Country	Name	City	State
India	Panineeya Institute of Dental Sciences	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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