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Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis

Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre (Other)
Overall Status
Completed
CT.gov ID
NCT03011086
Collaborator
(none)
70
Enrollment
1
Location
35
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    70 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis - a Clinico-pathological Study
    Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Nov 1, 2017
    Actual Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of auto antibodies in oral sub mucous fibrosis [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Panineeya Institute of Dental Sciences Hyderabad Telangana India 500060

    Sponsors and Collaborators

    • Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

    Investigators

    • Principal Investigator: NALLAN CHAITANYA, MDS, ASSOCIATE PROFESSOR

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NALLAN CHAITANYA, ASSOCIATE PROFESSOR, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
    ClinicalTrials.gov Identifier:
    NCT03011086
    Other Study ID Numbers:
    • PMVIDS/OMR/0016/2014
    First Posted:
    Jan 5, 2017
    Last Update Posted:
    Dec 19, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by NALLAN CHAITANYA, ASSOCIATE PROFESSOR, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
    Autoantibodies, Oral Submucous Fibrosis
    Additional relevant MeSH terms:
    Oral Submucous Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Dec 19, 2017