RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
1 NAME OF THE Dr. POOJA BHATT
CANDIDATE AND V.S Dental College and Hospital,
ADDRESS VV Puram, KR Road,
2 NAME OF THE VOKKALIGARA SANGHA DENTAL
INSTITUTION COLLEGE AND HOSPITAL
3 COURSE OF STUDY AND MASTER OF DENTAL SURGERY IN
SUBJECT ORAL MEDICINE AND RADIOLOGY
4 DATE OF ADMISSION JUNE 2011
5 TITLE OF THE TOPIC ASSESSMENT AND CORRELATION
BETWEEN FUNCTIONAL AND
HISTOLOGICAL STAGING OF ORAL
SUBMUCOUS FIBROSIS - A CLINICO-
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Oral submucous fibrosis is an insidious chronic disease predominantly found in Indians and
South East Asians. It’s a precancerous condition, the aetiology of which is mainly attributed
to habit of areca nut chewing. Other causes include consumption of chillies, nutritional
deficiency, altered salivary constituents and autoimmunity.
Its prevalence in Indian population is 0.2-0.5% with chances of malignant transformation in
3-7.6% of cases.
The clinical symptoms begin with burning sensation of mucosa with hot and spicy food.
Excessive salivation, blisters, ulceration and altered gustatory sensations follow soon. This
gradually worsens to inability of opening mouth, feeling of stiffness spreading to tongue,
floor of mouth and pharynx.
Depending on inter incisal opening, symptoms and presence of palpable fibrous bands OSMF
is divided in different clinical stages.
Depending on histological features ranging from early epithelial hyperplasia to advanced
atrophy which is always associated with juxta epithelial inflammatory reaction and
fibroblastic changes in lamina propia OSMF is again divided in a number of stages.
The aim of the study is to correlate the clinical severity with the histological changes of
OSMF patients which would further assist the clinicians to formulate a definite treatment
6.2 REVIEW OF LITERATURE:
A study was conducted by Ganiga Channaiah Shivakumar et al to correlate the functional and
the histological stages of oral submucous fibrosis and the correlation was found to be highly
A study was done by Haider et al to investigate the association of bands in oral submucous
fibrosis and extent of mouth opening. It was found that palpable bands were present at the
back of mouth in mild cases and with increase in severity they were present anteriorly as
A study was done by Khanna et al by categorizing oral submucous fibrosis patients into four
types based on their clinical and histological features. Different treatment modalities were
used for all 4 categories & it was found that while medical treatment gave good results for
earlier cases, surgery was the only solution for advanced groups3
A study was conducted by Denny E Ceena et al to assess the severity of oral submucous
fibrosis and correlate clinical and functional stages with histopathological stages and analyse
collagen distribution in different stages of OSMF using picrosirius red stain under polarized
microscopy. It was found that tight packing of collagen fibre in OSMF progressively
increased as the disease progressed from early to advanced stages and it was observed that
comparison of functional and histological stages was more reliable4.
A study was conducted by Kiran Kumar K.et al to correlate the clinical stage and
histopathological grade of OSMF. No direct correlation was found and extent of fibrosis in
different regions of oral mucosa and involved muscles were considered as contributory
factors for such variation5.
6.3 OBJECTIVES OF THE STUDY:
1) To assess functional stage of OSMF patients.
2) To assess histological stage of OSMF patients.
3) To correlate the functional and histological stages in OSMF patients.
7. MATERIALS AND METHODS:
7.1 Sources of data:
30 OSMF patients will be selected from the Department of Oral Medicine and
Radiology, V.S.D.C.H., Bangalore, Karnataka.
7.2 Inclusion Criteria:
1) OSMF patients willing to undergo biopsy will be included.
2) Only individuals with clinically detectable fibrous bands will be included
Clinical criteria for diagnosis of OSMF –
Hardening of mucosa
Presence of fibrous bands
Inability to open mouth completely.
7.3 Exclusion criteria:
1. Patients already undergoing treatment for OSMF will not be included.
2. Debilitated /Immunocompromised patients and those requiring other emergency
treatments will not be included.
3. Patients with TMJ disorders sharing similar complaints of incomplete mouth opening
will not be included.
7.4 PLACE OF STUDY:
Department of Oral Medicine and Radiology, V.S.D.C. and Hospital, K. R. Road, V. V.
Puram, Bangalore, Karnataka
7.5 STUDY DESIGN:
7.6 STUDY DURATION:
7.7 SAMPLE DESIGN:
7.8 SAMPLE SIZE:
7.9 PROPOSED STATISTICAL ANALYSIS:
chi square test
7.10 Study material
1. Divider and scale for clinical staging.
2. Punch biopsy sample (3 mm) for histological staging.
7.11 Study method
1. Informed consent from recognised OSMF patients will be obtained.
2. Necessary blood investigations required prior to biopsy will be done.
3. Clinical examination will be carried out and clinical signs like inter incisal mouth opening
from mesio incisal angle of upper central incisor to mesio incisal angle of lower incisor
will be recorded in millimetre.
4. BIOPSY PROCEDURE
a. Local anaesthesia will be administered and a punch biopsy will be done from region
of fibrous palpable bands, followed by post operative instructions to the patient.
b. The specimen so obtained will be preserved in 10% formalin and send for histological
5. The functional and histological staging of OSMF will be done according to Khanna et al.
Clinical subjects will be grouped into 4 categories according to the functional staging
Gp I very early case- mouth opening >36 mm
Gp II early case-mouth opening 25-35 mm
Gp III moderately advanced cases – mouth opening 15-25 mm
Gp IVa advanced cases- mouth opening 2-15 mm
Gp IVb advanced cases with premalignant changes and malignant transformation.
Histologically subject samples will be divided in 4 groups
Gp I very early- 1.fine fibrillar collagen network interspersed with marked
2. Blood vessels dilated and congested.
3. Large aggregate of plump fibroblasts with abundant
4. Inflammatory cells-PMN with few eosinophils.
5. Epithelium normal, with occasional hyperplasia.
Gp II early - 1. juxta epithelial hyalinization with collagen present as thickened
but separate bundles.
2. Blood vessels dilated and congested.
3. Moderate number of young fibroblasts.
4. Inflammatory cells –PMN, eosinophils and occasional plasma
5. Flattening or shortening of rete pegs with varying degree of
Gp III moderately advanced- 1. juxta epithelial hyalinization is present.
2. Faintly discernible collagen bundles separated by very
slight, residual oedema.
3. Muscle fibres interspersed within collagen fibre reveal
the beginning of degeneration and irregularity of
4. Blood vessels constricted.
5. Mature fibrocytes with scanty cytoplasm and spindle
6. Inflammatory cells-lymphocytes and plasma cells.
7. Epithelium markedly atrophic with total loss of rete
Gp IV advanced- 1.collagen hyalinised as a smooth sheet eliminating all
evidence of individual bundles.
2. extensive fibrosis obliterating the mucosal blood
vessels and eliminating melanocytes.
3. Fibroblasts markedly absent within hyalinised zones.
4. Extensive degeneration of muscle fibers.
5. Total loss of rete pegs with mild to moderate atypia.
6. The clinical and histological data will be collected and statistical analysis using chi
square test will be done.
7.12 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR
INTERVENTION TO BE CONDUCTED ON PATIENTS OR HUMANS
OR ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY
For the study, punch biopsy will be taken.
7.13 HAS THE ETHICAL CLEARANCE BEEN OBTAINED FROM
8. LIST OF REFERENCES:
1. Ganiga Channaiah Shivkumar, Shivakumar Sahana. “Correlation between functional
and histological staging of Oral Submucous Fibrosis.” J of Indian Academy of Oral
Medicine and Radiology.July-sept2010;22(3):133-135
2. S .M Haider , A.T Merchant, F.F Fikree, M.H.Rahbar. “Clinical and Functional
staging of oral submucous fibrosis”. British J of oral and maxillofacial
3. J.N Khanna, N.N Andrade. “Oral submucous fibrosis-a new concept in surgical
management. Report of 100 cases.” Int. Journal oral maxillofacial surgery 1995,
4. Deeny E Ceena, T.S Bastian, Ashok L., Rajeshwari G Annigeri.“Comparative study
of clinicofunctional staging of oral submucous fibrosis with qualitative analysis of
collagen fiber under polarizing microscope.”Indian J of dental research
5. Kiran Kumar K.,Saraswathi T.K, Ranganatha K.,Uma Devi M, Joshua Elizabeth.
“Oral submucous fibrosis –A Clinicohistopathologic Study in Chennai.”
Indian J of dental research 2007, 18(3):106-111
9 Signature of candidate
10 Remarks of the guide
11 Name and designation of
11.1 Guide Dr. M. Manjunath MDS
Prof. and HOD,
Department of Oral Medicine and Radiology
11.5 Head of the department Dr. M. Manjunath MDS
Prof. and HOD,
Department of Oral Medicine and Radiology
12 12.1 Remarks of the chairman and
I ___________________son/daughter of __________________ aged ________ resident of
________________________________ being under the treatment of Dr. Pooja Bhatt do hereby give
consent to the performance of drugs/ medical/ surgical/ anaesthesia/ diagnostic procedure upon
myself. The procedure has been explained to me in my own language and also the likely adverse
effects of the drugs being used has been explained and I agree that no responsibility will be attached
to the surgeon or the hospital staff.
Date: Signature of the patient/relative.
Signature of doctor