Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis

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

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

Study Overview

• Status: Completed
• Conditions: Oral Submucous Fibrosis

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500060
      • Panineeya Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total number of patients were 70 patients (Group A- 35 OSMF patients, Group B- 35 controls) of both the genders

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
oral sub mucous fibrosis; patients suffering with oral sub mucous fibrosis due to gutka/pan chewing confirmed by clinical examination
control group; patients having gutka/ pan chewing habit without oral sub mucous fibrosis in oral cavity

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Investigators: Principal Investigator: NALLAN CHAITANYA, MDS, Associate Professor

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: January 2, 2017
• First Posted (ESTIMATE): January 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Autoantibodies, Oral Submucous Fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Fibrosis; Oral Submucous Fibrosis
• Other Study ID Numbers: PMVIDS/OMR/0016/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO