RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE
AND ADDRESS:
(BLOCK LETTERS) / DR. VINI ARORA
C/o Mr. CHARANJEET ARORA
22, NAROTTAM KUNJ
BARRACK ROAD
BEHIND MADHU NAGAR
AGRA-282001
UTTAR PRADESH
PHONE NO: 0562-3244907, 09343293190, 09844896975
LOCAL ADDRESS:
(BLOCK LETTERS) / DR. VINI ARORA
POST GRADUATE STUDENT
DEPT OF ORAL MEDICINE AND RADIOLOGY
AL-BADAR RURAL DENTAL COLLEGE AND HOSPITAL,
GULBARGA-585102
KARNATAKA
ADDRESS FOR CORRESPONDENCE / DR. VINI ARORA
GUEST ROOM, NEW AL-BADAR GIRLS HOSTEL, HOUSE NO.1-101,
BEHIND ASIAN PLAZA
AIWAN-E-SHAHI ROAD
GULBARGA-585102
KARNATAKA
2. / NAME OF THE INSTITUTION / AL-BADAR RURAL DENTAL COLLEGE AND HOSPITAL,
GULBARGA-585102
KARNATAKA
3. / COURSE OF THE STUDY AND SUBJECT / MASTER OF DENTAL SURGERY IN ORAL MEDICINE AND RADIOLOGY
4. / DATE OF ADMISSION TO COURSE / 26-05-2010
5. / TITLE OF THE TOPIC / “CORRELATION OF HABITS AND CLINICAL FINDINGS WITH HISTOPATHOLOGICAL DIAGNOSIS IN ORAL SUBMUCOUS FIBROSIS”
6. / BRIEF RESUME OF THE INTENDED WORK
6.1. / Need For The Study
Oral Submucous Fibrosis (OSF) is an insidious, chronic disease affecting any part of the oral cavity and sometimes the pharynx and oesophagus. It is characterized by a mucosal rigidity of varying intensity due to the fibroelastic changes of the juxtaepithelial layer, resulting in a progressive inability to open the mouth. This disease predominantly occurs in Indians and South East Asians. Over the years, the incidence of OSF has increased manifold in various parts of the Indian subcontinent including the North Karnataka and Gulbarga region.
Consumption of chillies, nutritional deficiency, chewing of areca nut alone or in combination, chewing tobacco, smoking, alcohol, genetic susceptibility, altered salivary constituents, autoimmunity and collagen disorders may be involved in the pathogenesis of this condition.
Over the past several decades different aspects of OSF have been analyzed using simple case reports, population-based studies, hospital-based case control studies, animal experiments, in vitro human fibroblast culture studies, histopathological studies with light microscopy and transmission and scanning electron microscopy. Yet, there is a paucity of studies which correlates the frequency and duration of habits and clinical features to the various histopathological changes of OSF.
This study is intended to arrive at a comprehensive correlation between the frequency and duration of addictions with the clinical staging and histopathological grading.
6.2 / Review of Literature
Oral Submucous Fibrosis is a common oral health problem in India. A study was conducted in Allahabad on 239 patients suffering from OSF from 2004-2008 to correlate the histopathological diagnosis with habits and clinical findings. The study concluded that widespread habit of chewing dohra/paan masala is a major risk factor of OSF, especially in younger age group. An increase in histopathological grading was found with severity and duration of addiction habit. However no significant correlation was found between clinical staging and histopathological grading.1
A hospital-based study was conducted by some investigators in 75 OSF cases in Chennai during the period from 2000-2003. The results of the study showed that all forms of areca nut products were associated with OSF. Chewing of paan masala was associated with early presentation of OSF as compared to chewing of the betel nut. Out of 57 cases which were in clinical stage II, 91.2% had histological grading I and II in equal proportions and 8.8% had histological GRADE III. Out of 13 cases that showed a clinical stage III, 52% showed a histological grade of II, 40% grade III and 8% grade I. They concluded that there was no direct correlation between clinical stages and histopathological grading.2
A study was conducted in Davangere on 50 subjects, of whom 40 were patients with OSF and 10 were in the control group. Clinical, functional and histopathological study was done depending on definite criteria. A comparison of clinical, functional and histopathological stages of OSF was statistically analyzed. The study concluded that the comparison of clinical and histopathological staging did not provide any valuable information as to the severity of the disease. However, the comparison of the functional staging with histopathological staging was more reliable in providing the severity of the disease.3
A prospective study was conducted in Hyderabad which examined the in vivo effects of pan masala/gutkha and betelquid chewing on buccal mucosal cytology in 50 patients with OSF and 40 controls. The percentage of nucleolated intermediate cells or proliferative fraction of buccal mucosa cells was significantly higher in all habitual chewers than controls. Pan masala/gutkha chewers presented with OSF after 2.7 +/- 0.6 y of use whereas the betelquid users presented with OSF reported 8.6 +/- 2.3 y of use (p 0.05). The study concluded that habitual chewing of pan masala/gutkha is associated with earlier presentation of oral submucous fibrosis than betelquid use.4
A study conducted in Belgaum on 205 patients of OSF evaluated all the cases for the age, sex, site of involvement, duration of disease, associated habits and common presenting symptoms, presence of other mucosal lesions, malignant potential and the histopathology. A strong association with smokeless tobacco use especially arecanut in the form of gutkha was established and was related to earlier development of OSF. A total of 11.6% of cases were associated with malignancy and occurred predominantly in males.5
6.3 / Aims and Objectives of the study
Aims:
1.  To correlate the frequency and duration of habits with clinical and functional staging.
2.  To correlate the frequency and duration of habits with histopathological grading.
3.  To correlate the clinical and functional staging with histopathological grading.
Objectives:
1. It may help to assess the prognosis of the disease.
2. In future, it may aid in planning the treatment of OSMF
7. / Materials and Methods
7.1 / Source of data:
The out patients who will report to the Department of Oral Medicine and Radiology, Al-Badar Rural Dental College and Hospital. The study will include a total of 80 subjects, of which 40 will be patients with OSF, and 40 will be in control group. Informed consent will be taken from all the patients for enrollment in the study.
Inclusion criteria:
Patients who have the deleterious habit of using areca nut and areca nut containing products, tobacco mixed with areca nut in different forms, alcohol, are satisfying the clinical criteria as given in Bailoor D.N and Nagesh(2005)7 and who will be histopathologically confirmed as having OSF.
Controls were selected after confirming that they are not having any deleterious habits as mentioned above and do not show any signs and symptoms of OSF.
Exclusion criteria:
Oro mucosal disorders with clinical features same as OSF.
Any systemic disorders which can cause similar symptoms.
Patients who are under treatment for OSF.
Clinically diagnosed cases of OSF not ready for incisional biopsy.
Clinically diagnosed cases of OSF without any habits.
7.2 / Method of collection of data
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8) / 80 OPD patients, of whom 40 will be patients with OSF and 40 will be in the control group from the Department of Oral Medicine and Radiology of Al-Badar Rural Dental College and Hospital. The experimental group will be clinically examined by using the criteria as given in Bailoor D.N & Nagesh(2005).7
Presence of burning sensation.
Blanching of the oral mucosa.
Restricted mouth opening.
Restricted tongue protrusion.
Palpable fibrous bands
The study will be conducted by strictly adhering to the ethical protocols and written consent will be obtained from all the patients to include them in the study. The parameters like mouth opening(interincisal distance),cheek flexibility and tongue protrusion will be recorded as mentioned by Ranganathan et al.8
Clinical and functional staging of OSF will be done according to Haider et al 6 and as modified by Ceena et al.3
Clinical staging will be based on the presence of palpable fibrous bands and is as follows:
STAGE I- buccal bands only
STAGE II- faucial and buccal bands only
STAGE III- faucial, buccal and labial bands
Functional staging used will be as follows:
STAGE A- mouth opening greater than or equal to 20 mm
STAGE B- mouth opening 11 -19 mm
STAGE C- mouth opening less than or equal to 10 mm.
Routine hematological examination will be done for all the patients in the experimental group before subjecting them to incisional biopsy for histopathological examination.
For confirmation of the clinical diagnosis, histopathological examination with incisional biopsy from the buccal mucosa will be carried out because most of the cases exhibit clinically evident changes in this area and ease of accessibility for biopsy procedure. The results will be recorded according to the traditional grading by Pindborg and Sirsat.1
For the control group buccal mucosal tissue biopsies will be done who will undergo minor oral surgical procedures like removal of impacted tooth with no detrimental habits.
Duration of the study
2 years study from September 2010 to August 2012.
Statistical Analysis
Descriptive data that includes mean, standard deviation and percentage will be calculated for each group.
Chi square test will be utilized to determine association between variables.
Students‘t’test will be utilized to find out the mean age difference between genders.
Correlation is used to know the relationship between the relative variables.
For all tests, a ‘p’ value of 0.05 or less will be utilized for statistical significance.
7.3 / Does the study need any investigation or interactions to be conducted on patients or animals?
Yes, it requires collection of blood sample for hematological examination and collection of tissue specimen from oral cavity followed by histopathological examination.
7.4 / Has the ethical clearance been obtained from your institution (in case of 7.3)?
Yes
8. / List of References
1. Pandya S, Chaudhary AK, Singh M, Singh M, Mehrotra R. Correlation of histopathological diagnosis with habits and clinical findings in oral submucous fibrosis. Head and Neck Oncology 2009;1:10.
2. Kumar KK, Saraswathi TR, Ranganathan K, Devi MU, Elizabeth J. Oral Submucous Fibrosis: A clinico-histopathological study in Chennai. Indian J Dent Res 2007;18(3):106-11.
3. Ceena DE, Bastian TS, Ashok L, Rajeshwari G Annigeri. Comparative study of clinicofunctional staging of oral submucous fibrosis with qualitative analysis of collagen fibers under polarizing microscopy. Indian J Dent Res 2009;20(3):271-76.
4. Babu S, Bhat RV, Kumar PU. A comparative clinico-pathological study of oral submucous fibrosis in habitual chewers of pan masala and betelquid. J Toxicol Clin Toxicol 1996;34(3):317-22.
5. Angadi PV, Rekha KP. Oral submucous fibrosis: a clinicopathologic review of 205 cases in Indians. Oral Maxillofacial Surg.Springer-Verlag.Published online:23 April 2010. Downloaded from http://www.ncbi.nlm.nih.gov/pubmed on 9th November 2010.
6. Haider SM, Merchant AT, Fikree FF, Rahbar MH. Clinical and functional staging of oral submucous fibrosis. Br J Oral Maxillofac Surg 2000;38:12-5.
7. Bailoor D.N, Nagesh. Fundamentals of Oral Medicine and Radiology. Jaypee Brothers Medical Publishers Ltd;2005.p.183.
8. Ranganathan K, Devi MU, Elizabeth J, Bhardwaj A, Rooban T, Vishwanathan R Mouth opening, cheek flexibility and tongue protrusion parameters of 800 normal patients in Chennai, south India- A base line study to enable assessment of alterations in oral submucous fibrosis. JIDA 2001;72:78-80.
9. / Signature of the candidate
10. / Remarks of the Guide
11.1 / Name and Designation of the Guide (BLOCK LETTERS) / Dr. SYEDA ARSHIYA ARA
M.D.S.
PROFESSOR
DEPT. OF ORAL MEDICINE & RADIOLOGY
AL-BADAR RURAL DENTAL COLLEGE AND
HOSPITAL, GULBARGA
11.2 / Signature of guide
11.3 / Head of the Department: / Dr. GIRISH KATTI
M.D.S.
PROFESSOR & H.O.D.
DEPT. OF ORAL MEDICINE & RADIOLOGY
AL-BADAR RURAL DENTAL COLLEGE AND
HOSPITAL, GULBARGA
11.4 / Signature of Head of Dept.
12. / Remarks of Principal
12.1 / Signature of Principal