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B.D.S.M.SC., F.D.S.R.C.S.


1. Introduction . 2. Aim of study . 3. Material and Method 4. Study setting . 5. Duration of study . 6. Study population .. 7. Data Collection Procedure . 8. Inclusion Criteria .. 9. Exclusion Criteria . 10.Recording of data . 11.Ethical and legal consideration .. 12.Ethical Approval 13.Written Informed Consent 14.Supervision . 15.Study procedures .. 16.Pre-study Procedures 17.Statistical analysis . 18.Reference 19.Appendix - I . 20.Appendix - II . 21.Proforma 1 (Clinical) 22.Proforma 2 (Histopathological)


It is certified that Mr. Adnan ul Haq has carried out research the topic is FREQUENCY OF DYSPLASTIC CHANGES IN PATIENTS WITH ORAL SUBMUCOUS FIBROSIS at Isra University Hospital hyderabad under my supervision and that the work reported in this synopsis is original and distinct.

His synopsis is worthy of presentation of Isra University Hospital Hyderabad for award of the MDS Oral Pathology.

Signature of Supervisor

Prof. Dr. Abdul Qadir Khero Department of Dentistry Isra University, Hyderabad

Oral Submucuous Fibrosis(OSMF): It is a chronic inflammatory disease characterized by fibrosis of submucosa & deep connective tissues of oral cavity resulting in restriction in opening the mouth due to stiffness. OSMF is quite common disease in India and South East Asia and prevalence rate of about 0.4% among Indian population1. In Pakistan, female are more affected then males and ratio is about 1:2.32. Clinically OSMF affects the lining of the mouth and usually results in limited mouth opening, difficulty in protruding tongue, burning sensation with spicy foods and ulceration in oral mucosa and is characterized by increased production of collagen that causes in elasticity and atrophic changes in epithelium3,4,5. Betal chewing and some other factors such as nutritional deficiencies, immunity of the person, and genetic predisposition play important role in pathogenesis of OSMF6-12. In India OSMF can be transformed into carcinoma at an incidence rate of 7.6 %13. Dysplasia is characterized by alteration in the epithelial cells and in their morphology leading in developing the risk of neoplasia14-16. Dysplastic changes has various characteristics in Pre-cancerous and cancerous condition proposed by WHO in 199717. Toludine blue is a sensitive tool to identify high grade dysplasia,low grade dysplasia or no dysplasia by the presence of high risk molecular clones18-23. The purpose of my study is to find out the frequency of dysplastic changes among OSMF patient. Early recognition of dysplasia may provide an opportunity for an early diagnoses and treatment to save the life of the patients.



The objective of the study is to determine the frequency of dysplastic changes in oral submucous fibrosis in out Patient Department of Isra University Hospital Hyderabad.

Study setting:
Patient with oral submucous fibrosis attending the Isra Dental College OPD, Isra University Hospital Hyderabad.

Study Design:
Cross sectional study

Duration of Study:
Two years

Study Population:
We will take those patients who will come in Isra university dental OPD during my study period with oral submucous fibrosis.


Specimen will be preserved in 10% formalin. A thorough gross section of the specimen will be done according to Proforma (appendix I II) and representation blocks will then be processed in different concentration of alcohol and after that will be embedded in paraffin. After cutting the paraffin blocks by using Microtome, the sections will be stained with Eosin and Haemotoxylin stain and under light microscope all the Histopathological findings will be noted.


Light microscope with camera Big knife and scalpel Glass jars for processing tissue in different concentration of Alcohol Microtome Glass slide and cover slip Eosin and Haemotoxylin stains Mirco Cup Forceps Toluidine blue Staining

Inclusion Criteria:

Patients with Clinical diagnosis of oral submucous


Exclusion Criteria:
There will be no exclusion criteria.

Recording of data
Research data will be recorded on pre-designed proforma (appendix I II) and data will be analyzed by using SPSS version II. No specific biostatical test will applied.

Ethical and legal consideration: Ethical Approval:

Local ethical committee approval will be obtained before the start of study form the local research ethical committee, Isra University Hospital Hyderabad.

Written Informed Consent:

All participants of the study will be required to give their informed, written and witnessed consent prior to the commencement of the study, after the nature of study and the procedures involved have been explained. Patients will receive written information concerning their participation in the study and will be assured that they can withdraw from the study, at any time, without being required to state a reason and this would to affect their future management.

Supervision will be provided by the supervisor and co-supervisor.

Study procedures: Pre-study Procedures:

Written information about the study will be given to each patient before attending the clinic. All participants of the study will undergo careful clinical evaluation including a full medical history and clinical examination to confirm the diagnosis of oral submucous fibrosis. Determination of whether the

patient fulfills the inclusion / exclusion criteria. Written, witnessed informed consent will be obtained and a copy given to the patient. Assign the patient a study number.

Statistical analysis:
Statically analysis will be done with the help of statistical and mean percentage will be taken.


Murti PR. Bohsle RB Ghupta PC, Daftary DK, Pindborg JJ. Mehta FS Etiology of Oral Submucous fibrosis with special reference to the role of area nut chewing. J. Oral Pathol Med 1995; 24: 145-52.


Aziz SR Oral Submucous fibrosis an unusual disease, JNJ Dent ASso Spring 1997, 68 (2) : 17-9


Warnakulasuriya S. Semi-quantitative clinical description of oral submucous fibrosis. Ann Dent 1987; 46: 18 21.


Pindborg JJ,Chawla TN, Srivastava AN, Gupta D, Mehrotra ML, Clinical aspects of oral submucous fibrosis. Acta Odontol Scand 1964; 22: 679 91.


De Wall J, Oliver A, Van Wyk CW, Marits JS. The fibroblast population in oral submucous fibrosis. J Oral Pathol Med 1997; 26: 69 74. Rajalatha P. Vali S. Molecular pathogenesis of oral submucous fibrosis. I Oral Pathal Med 2005; 34: 321 8.



Murti PR, Bhonsle RB, Pindborg JJ, PC, Daftary DK, Metha FS. Malignant transformation rates in oral submucous fibrosis over a 17-year period. Comm unity Dent Oral Epidemiol 1985; 13: 340 1.


Murti PR, Bhonsle RB, Gupta PC, V Daftary DK, Pindborg JJ, Mehta PS. Aetiology of oral submucous fibrosis with special reference to role of areca nut chewing. I Oral Pathol Med 1995; 24: 14552.


Tilakaratne NM, Klinikowski MF, Saku T, Peters TJ, Warnakulasuriya S. Oral submucous fibrosis: review on aetiology and pathogenesis. Oral Oncol 2006; 42: 5618.


Rajendran R. Oral submucous fibrosis : Review on aetiology and pathologenesis and future research . Bull world health 985-96 organ 1994: 72


Pilllai R. Balaram P. Reddiar K.S. Pathogenesis of oral submucous fibrosis. Relationship to risk factors associated with oral cancer 1992;69:2011-20


Trivedy CR, Warnakulasuriya KA, Peters TJ, Senkus R, Hazarey VK Johnson NW. Raised tissue copper levels in oral submucous fibrosis. Oral Pathol Med. 2000;29;241-8


Murti PR,BhonsleRB,Pindborg JJ,et al.Malignant transformation rate in in oral submucous fibrosis a 17 year eriod . community dent.Oral Epidemiol 1985;13;340-341.


Crissman JD, Zarbo RJ. Dysplasia, in-situ carcinoma, and progression to invasive squamous cell carcinoma of the upper aerodigestive tract. Am J Pathol 1989; 13: 516.


Krutchkoff DJ, Eisenberg E, Anderson C. Dysplasia of oral mucosa: a unified approach to proper evaluation. Modern Pathol 1991; 4: 113 Hazarey V, Daftary D, Kale A, Warnakulasuriya S. Proceedings of the panel discussion on standardized reporting of oral epithelial dysplasia. J Oral Maxillofac Pathol 2007; 11: 868.



Gale N, Westra W, Pilch BZ et al. Tumours of the oral cavity and oropharynx. In: Barnes L, Everson JW, Reichart P, Sidransky D, eds. World Health Organization Classification of Tumours: Pathology and Genetics of Head and Neck Tumours. Lyon: International Agency for Research on Cancer, 2005: 16688.


Mashberg A, Samit A. Early diagnosis of asymptomatic oral and oropharyngeal 1995;45:32851. squamous cancers. CA Cancer J Clin


Onofre MA, Sposto MR, Navarro CM. Reliability of toluidine blue application in the detection of oral epithelial dysplasia and in situ and invasive squamous cell carcinomas. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2001;91:53540.


Epstein JB, Feldman R, Dolor RJ, Porter SR. The utility of tolonium chloride rinse in the diagnosis of recurrent or second primary cancers in patients with prior upper aerodigestive tract cancer. Head Neck 2003; 25:91121.


Martin IC, Kerawala CJ, Reed M. The application of toluidine blue as a diagnostic adjunct in the detection of epithelial dysplasia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1998;85:444 6.


Guo Z, Yamaguchi K, Sanchez-Cespedes M, Westra WH, Koch WM, Sidransky D. Allelic losses in OraTestdirected biopsies of patients with prior upper aerodigestive tract malignancy. Clin Cancer Res 2001;7: 19638.


Epstein JB, Zhang L, Poh C, Nakamura H, Berean

K, Rosin M. Increased allelic loss in toluidine blue-positive oral premalignant lesions. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2003;95:4550

Appendix 1
The aim of the study is to determine the frequency of dysplastic changes in oral submucous fibrosis in dental out patient department of Isra University Hospital Hyderabad.

PRINCIPLE INVESTIGATORS: PROFESSOR ABDUL QADIR KHERO I.....of. understand the nature and purpose of the study as explained to me by the investigator Mr. Adnan and I am free to ask any questions that my arise. I confirm that I have been given written information about the study and have been informed of any problems that may occur. I am aware that I can with draw from the study without stating a reason.

I agree to the following procedures:

1. To allow the study doctors to ask questions about my habits. 2. To allow the study doctors to examine my oral cavity. 3. To allow the study doctors to treat me as they want. 4. To allow the study doctors to take biopsy & apply any medicine in my

oral cavity for the purpose of study.

5. I have to come to my study doctors whenever he told me to come

during the period of study.

I understand that in the event of my deteriorating health as a result of taking part in this project, I may submit a claim to the health authority or the Isra University, Hyderabad for compensation to be considered. I understand that I do not have to prove that anyone involved in the research project has been negligent before submitting a claim. If negligence can be established, I understand that my claim for compensation will be dealt with in accordance with the legal principles affecting claims for damage for personal injuries. If negligence cannot be established, the health authority or Isra University will consider any claim on its merit and in appropriate circumstances, may decide to offer extra gratia payment. I declare that I am not taking part in any trial at this time.

Signed Name and address of witness: Occupation:





The aim of the study is to determine the frequency of dysplastic changes in oral submucous fibrosis in dental out patient department of Isra University Hospital Hyderabad.

It is chronic Inflammatory disease characterized by fibrosis of submucosa and deep connective tissues resulting is restriction in opening the mouth due to stiffness. Affecting the lining of the mouth usually resulting in limited mouth opening, difficulty in protruding tongue, burning sensation with spicy foods and ulceration in oral Mucosa and clinically we can confirm our diagnosis of Oral Submucous Fibrosis by the presence of prominent fibrous bands and pallor oral Mucosa.

A brief history will be taken and the oral cavity will be examined.

Management decisions will be taken by doctors.

Biopsy will be taken. Are there any tests? Yes (Biopsy)

CLINICAL PROFORMA NO. 1 Serial No._____________ BlO-DATA OF PATIENTS 1. Name: 2. Age & Sex: 3. Marital Status: 4. Ward/Bed No. 5. Occupation: 6. Address: _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ HISTORY Presenting Complaints ________________________ Pain ______________________ Localized Radiating Duration______________________ Onset__________________________ White Patch__________________________ Burning Sensation _____________________ Mouth Opening milimeter) _______________________ Ulceration_______________________________ Past History_______________________________ or dental discase MrNo.___________

Family History similar disease in close relatives Dental Complain

Addiction Habits 1.





Do you see Betel quid 1. Yes 2. Occasionally 3. No


Type of Betel quid 1. Mainpuri 2. Ghutka 3. Betel Nut 4. Pan 5. Mawa

3. 4. 5. 6. 7.

Age at which started using Betel quid ___________________ years. Quantity daily consumed ___________________ Do you sleep with betel quid in the mouth 1. Yes 1. Yes Do you see 1. Pan with Tobacco 2. Pan with lime 3. Pan with nut 4. Pan with catechu paste 2. Occasionally 2. Occasionally 3. No 3. No Do you smoke with Betel quid


Age at which started to eat ____________________ years.

Serial No. _______________ Mr No. _______________

GROSS EXAMINATION OF ORAL CAVITY LIP: Upper Lip Lower Lip Commissures Shape _____________ Colour_____________ Surface___________ BUCCAL MUCOSA Cheek Mucosa Retro molar area Buccoalveor Sulcus U/L Shape ______________ Colour_______________ Surface____________ SOFT PALATE Shape ______________ Colour___________ Surface____________

1. 2. Dorsal surface and lateral borders Inferior and ventral surface

Size ___________ Shape _________ Colour________ Surface__________

Toluidine blue
Sites ________________________________________ ________________________________________ ________________________________________


Enlarged, firm Nodes Mobile or Fixed ________________________________________ ________________________________________

Dysplasia Yes If Yes Mild _______________________________ Moderate ____________________________ Severe ____________________________ or No