Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis

NCT03011086 | Completed

• 1 other identifier: PMVIDS/OMR/0016/2014
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oral Submucous Fibrosis

Keywords

Autoantibodies, Oral Submucous Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead

Study Sites (1)

Panineeya Institute of Dental Sciences

Hyderabad, Telangana, 500060, India

Location

MeSH Terms

Conditions

Oral Submucous Fibrosis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• NALLAN CHAITANYA, MDS

  ASSOCIATE PROFESSOR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: January 5, 2017
• Study Start: January 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)