Oral Maxillofac Surg (2015) 19:201207

DOI 10.1007/s10006-014-0478-x

ORIGINAL ARTICLE

Oral submucous fibrosisa treatment protocol based

on clinical study of 100 patients in central India
Pravin Lambade & Pawan Dawane & Pradip Thorat

Received: 30 June 2014 / Accepted: 30 November 2014 / Published online: 17 December 2014
# Springer-Verlag Berlin Heidelberg 2014

Abstract
Purpose Oral submucous fibrosis till date is a very poorly
understood and unsatisfactorily treated disease with variable
signs and symptoms. In this paper, we have classified the
disease in different groups according to the clinical signs,
radiological assessment, histopathological confirmation,
progress, and severity of disease and proposed a treatment
algorithm for effective treatment of the disease in 100 patients.
Material and method In our study, we randomly selected 100
patients of oral submucous fibrosis and classified them in to
five groups based on clinical symptoms and radiological and
histopathological parameters. We have given specific treatment for each group and followed them up for 2 years
regularly.
Results We found that almost all patients got symptomatic
relief from the disease. Patients interincisal mouth opening
increased significantly. All patients can take regular diet.
Progressive malignant transformation can be detected earlier
to avoid future morbidity and mortality.
Conclusion Oral submucous fibrosis (OSMF) scoring index
is very effective to decide the severity of disease and progress.
Based on this scoring and grouping we can give definite
prompt treatment to the patients with satisfactory results. Such
a way this proposed scoring and staging can play major role in
controlling and treating this widespread global disease.

Keywords OSMF . OSMF scoring index . Treatment

algorithm . Radiological method of mouth opening

P. Lambade (*) : P. Dawane : P. Thorat

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,
Nagpur, India
e-mail: drpravinlambade@gmail.com

Introduction
Oral submucous fibrosis (OSMF) may be defined as an insidious, chronic disease affecting any part of the oral cavity and
sometimes the pharynx. Although occasionally preceded by
and/or associated with vesicle formation, it is always associated with a juxta-epithelial inflammatory reaction followed by
a fibroelastic change of the lamina propria, with epithelial
atrophy leading to stiffness of the mucosa and causing trismus
and inability to eat [1]. A condition resembling OSMF was
described as early as 600 B.C. by Sushruta and it was named
as vidari [2]. The characteristic features of OSMF are loss of
pigmentation, blanching, and leathery texture of oral mucosa;
depapillation and reduced movement of the tongue, progressive reduction of mouth opening; and sometimes sunken
cheeks.
OSMF occurs at any age but is most commonly seen in
adolescents and adults especially between 16 and 35 years [2].
The prevalence rate in India is about 0.20.5 % [3] and the
prevalence by gender varies from 0.2 to 2.3 % in males and
1.2 to 4.57 % in females [4]. The malignant transformation
rate (730 %) [5] poses global problems for public health
where in our study was 14 %. The etiology of OSMF is
multifactorial but remains obscure. Although areca nut is
considered to be the most important causative agent [3, 6],
and responses observed in individuals using areca nut vary in
relation to quantity and duration. Once initiated, OSMF is not
amenable to reverse at any stage of the disease process even
after cessation of the causative factor of areca nut chewing [4].
Because of variable clinical presentation in different patients,
it is needful to understand the progress and severity. To
understand this, we propose the scoring index.
Four parameters like, mouth opening, involvement of site
in the oral cavity, severity and extent of fibrosis and presence
of any malignant change were denominated while determining the OSMF scoring index and patients were divided into

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five groups depending on the score (Table 2). The purpose of

proposing this OSMF scoring index is to provide uniform
scoring system so as to decide the severity of disease and
specific established treatment modalities for a particular group
as we used in this study with 2 years follow-up.

Oral Maxillofac Surg (2015) 19:201207

grade I is associated with 5060, grade II associated with 40

50, and grade III less than 40 (Table 1).
When the site of oral submucous fibrosis considered in the
oral cavity, we find that the disease progresses from the
pterygomandibular raphe to the buccal mucosa, soft palate
and hard palate, tongue, and floor of the mouth, respectively.
Score related with site is designated with letter S. Five
different scores were given for site involvement (Table 2).

Patients and method

The study was prospective and nonrandomized. Institutional
ethical committee approval was taken before the start of study.
In this study, we selected 100 patients reporting to our institute
with variable clinical symptoms from mild to severe. We
classified the patients into five different groups depending
upon OSMF scoring index (Table 2).
We are introducing innovative and supplementary method
for the assessment of mouth opening. It is usually measured
between incisal edges of the upper and lower teeth, but in the
case of partially and completely edentulous patients, it is
difficult to measure mouth opening; also, sometimes during
treatment and follow-up, there can be exfoliation of teeth. And
there is difficulty to assess the mouth opening in such cases so
this method can be used effectively.
While considering mouth opening, we divided the patients
into three groups. Scoring for mouth opening is designated by
letter O. Grade I has a mouth opening of 4030 mm with a
score of 1, grade II has a mouth opening of 2920 mm with a
score of 2, and grade III less than 20 mm with a score of 3. We
complemented this interincisal mouth opening by novel radiological method by measuring the angle between the sellanasion plane and the lower border of the mandible on lateral
cephalogram with wide mouth opening (Fig. 1). We found that

Site 1 (S 1): pterygomandibular raphe area (score 1)

Site 2a (S 2a): pterygomandibular raphe and buccal mucosa (unilateral) (score 2)
Site 2b (S 2b): pterygomandibular raphe and buccal
mucosa (bilateral) (score 3)
Site 3 (S 3): pterygomandibular raphe, buccal mucosa,
hard palate, soft palate, and lip (score 4)
Site 4 (S 4): pterygomandibular raphe, buccal mucosa,
hard palate, soft palate, uvula, lip, floor of the mouth, and
tongue (score 5)
For malignant changes, we designated the score with letter
M.
Ma: the absence of any malignant changes (score 0)
Mp: the presence of mild to moderate dysplasia (score 1)
Ms: the presence of established malignant disease (score
2)
The severity of fibrotic bands is denoted with letter F.
F1: mild fibrosis with normal elasticity of mucosa (score
1)
F2: mottled and marble-like mucosa with moderate widespread sheet (score 2)
F3: thick broad fibrous bands and immovable mucosa
(score 3)
The final scoring for the disease is calculated by score O+
score S+score M+score F. We classified the patients into five
different groups (group I, group II, group III, group IV, and
group V) using OSMF scoring index and patients having the
score Ms is directly placed into group V.

Table 1 The interincisal mouth opening by measurement in

millimeters and its relationship with radiographic measurement

Fig. 1 Illustration of the radiographic method used for mouth opening

measurement

Grade

Mouth opening ()

Mouth opening (mm)

Grade I
Grade II
Grade III

6050
4940
<40

4030
2920
<20

Oral Maxillofac Surg (2015) 19:201207

Table 2 OSMF scoring
index

OSMF score

203

Groups

Mouth
opening (O)

Site (S)

Presence of
malignant feature
(clinical and
histopathological) (M)

Severity of fibrosis (F)

Group I

O1

S1

Ma

F1

67

Group II

O2

S2a

Ma

F2

O3

S2b
S2b

Ma

F3

O3

S3
S3

Mp

F3

O3

S4
S4

Ms

F3

910
1112
13

Group III
Group IV
Group V

Group I: score 13
Group II: score 67
Group III: score 910
Group IV: score 1112
Group V: score 13
In our study of 100 patients, we classified our patients into
five different groups as mentioned above and implemented
treatment as follows (Table 5). Before the commencement of
treatment, all patients were advised for the cessation of habit,
balanced diet, and postoperative physiotherapy.

and nasolabial flap depending upon the extent and site of the
defect.
Group V with a score of 13 Five patients of oral submucous
fibrosis with advanced established malignant disease were
treated with definitive radical surgical treatment with neck
dissection and removal of lesion followed by radiotherapy.
All the patients were followed up for 2 years.

Results
Group I with a score of 13 Forty three patients with a score
of 3 were treated with topical triamcinolone ointment thrice a
day on the buccal mucosa and pterygomandibular raphe area,
and patients with ulcers were given topical anesthetic gel for
the relief of pain. Multivitamins tablet containing lycopene,
beta carotene, alpha carotene, lipoic acid, and minerals like
zinc and selenium were given BD for effective result.
Group II with a score of 67 Thirty patients with a score
of 67 were treated with injectable steroids and antioxidants with physiotherapy. The submucosal injections of
triamcinolone acetonide (40 mg) and hyaluronidase
(1500 IU) with 2 % xylocaine at 15-day interval for
34 months were injected into the faucial pillars,
retromolar area, and buccal mucosa.
Group III with a score of 910 Thirteen patients with a score
of 910 were treated by surgical intervention in which
fibrotomy was done to remove fibrous band, coronoidectomy,
all third molar extraction, and flaps used for covering of defect
by nasolabial flap and buccal pad of fat.
Group IV with a score of 1112 Nine patients with a score of
1112 were treated by elimination of etiological factor of
premalignant condition other than OSMF like prohibition of
habit and sharp and broken teeth and then treated with excision of lesion and defects were covered with buccal pad fat

We treated the patients of all five stages with a specific

treatment algorithm as mentioned in the methodology. We
found satisfactory result as follows (Table 4 and Table 5):
Group I with a score of 3 Patients showed a marked relief of
symptoms after 3 months. With vigorous physiotherapy, patients achieved increased in the interincisal mouth opening in
the mean range of 56 mm in 1 month. Patient follow-up was
done for 2 year at regular interval to check the posttreatment
relapse and recurrence of symptoms (Table 3).
Group II with a score of 67 All patients responded favorably
revealed improvement in the clinical picture and experienced
an increase in mouth opening in the mean range of 56 mm
and regression of recurrent stomatitis, ulceration, and burning
sensation (Table 3).
Group III with a score of 910 Buccal fat pad revealed
satisfactory healing within 23 weeks after the surgery, giving
good mucosalization with minimum morbidity where
nasolabial flap takes more time. In general, surgical treatments
resulted in significant improvement of trismus in patients with
severe limitation of mouth opening (<20 mm). During 2 years,
the interincisal mouth opening declined by 510 mm as compared to that at the end of surgery in 46.15 % of treated
patients (Table 4).

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Oral Maxillofac Surg (2015) 19:201207

Table 3 Illustration of
results for group I and
group II

No. of patients

Group I

43

Group II

30

Improvements of symptoms (%)

1st month
2nd month
3rd months
1st month
2nd month
3rd month

Group IV with a score of 1112 In this group, 55.55 %

patients responded favourably to conservative management
with antioxidant therapy along with cessation of habit;
44.44 % patients were treated with excision of lesion along
with surgical management for oral submucous fibrosis and
flap used for covering the defect. Follow-up of patients was
done for 2 years and there is decrease in the interincisal mouth
opening by 510 mm in 44.44 % of patients (Table 4).
Group V with a score of 13 All patients of this stage were
treated successfully with good result. We do not come across
any recurrence at the end of 2 years. And there is decrease in
the interincisal mouth opening by 510 mm in 60 % of
patients (Table 4).

Discussion
Oral submucous fibrosis is considered as a disease of the
Indian subcontinent [7] because of its high occurrence and
confinement of the disease within Southeast Asia. Because of
the popularity and easy availability of the betel nut and its
product, the disease has broken all the borders of the region
and the age of the occurrence. Though by initial appearance of
the sign and symptoms of the disease the condition seems to
be benign, it has high malignant potential. Its premalignant
nature was first described by Paymaster in 1956 [8]. Older
studies showed a variable malignant transformation rate from
3 to 7.8 % [9] while recent studies have shown very high
malignant transformation rate from 7 to 30 % [5]. Now, the
time has come when we have to think seriously and take a
prompt action with oral submucous fibrosis which is taking a
toll in millions of population.
As explained earlier, the oral submucous fibrosis is the
disease of fibrosis resulting from disturbed metabolism of
the collagen fibers secreted by the fibroblast of the
subepithelial connective tissue of the oral mucosa. The patient
affected with oral submucous fibrosis reported a wide range of
symptoms like burning sensation and stomatitis, stiffness of
the mucosa, reduced mouth, altered speech, and, in advanced

Burning sensation

Stomatitis

Trismus

88.37
93.02
97.67
80
86
100

83.72
95.34
100
70
83.33
100

72.09
83.72
100
63.33
80
100

The decrease in the

interincisal distance
in the range of 35 mm
after 2 years of follow-up
No

23.33 %

stages, with swelling and proliferative growths. Also, the

fibrosis may involve one part of the oral cavity or more than
one at the same time like buccal mucosa, soft palate, hard
palate, and tongue. So the patient with oral submucous fibrosis
reports with different clinical presentation, which gives rise to
the need of one definite system to determine the stage of the
disease so that severity of the disease can be understood.
Though the disease has a long history of more than 600
B.C., the treatment for the condition is still only symptomatic.
The disease is of obscure etiology so the main line of treatment is symptomatic relief only, which varies with the stage of
the disease. Various attempts have been taken by different
authors to classify this disease entity according to trismus
and interincisal mouth opening with the symptoms, site of
involvement, and association of the disease with other premalignant conditions [3]. But to date, no classification system
can give the idea of the site, severity, and progress and
association with malignancy in the single system. Here, we
are proposing a classification system which will give the exact
site, severity, and stage of the disease so as to implement
suitable effective treatment for best outcome and prognosis
of the disease entity.
In our institute, there are more than 1015 % of daily
reported patients coming with oral submucous fibrosis.
Though in literature it is said that the disease has female
predominance, we came across male predilection with higher
percentage of young population in the age range of 20
40 years. We made such an attempt to propose the group of
disease considering all the aspects of the disease including
location, number of the site, range of mouth opening of the
patient and its association with other premalignant condition,
and malignant transformation.
When we see for the involvement of the site of mucosa, we
found there is a variation in site and its number. It is cleared
from our study that the most common site for the involvement
is the pterygomandibular raphe area and the buccal mucosa.
The disease entity has progress from pterygomandibular raphe
area to the buccal mucosa then the hard and soft palate. In a
few cases, we found unilateral involvement showing the localized effect of the betel nut and its product in the mucosa

60 %
3040

44.44 %
3040

46.15 %

>20 mm
100
100
100
60
80
100
80
80
100
05
Group V

1st month
2nd month
3rd month

>20 mm
100
100
100
88.88
100
100
66.66
77.77
88.88
09
Group IV

1st month
2nd month
3rd month

53.84
76.92
92.30
13
Group III

1st month
2nd month
3rd month

46.15
61.53
84.61

Trismus
Stomatitis
Burning
sensation

100
100
100

>20 mm

Mode of treatment
Mouth
opening
Improvements of symptoms (%)
No of
patients

Illustration of the result of group III, group IV, and group V

Table 4

205

Fibrotomy, coronoidectomy,
all 3rd molar extraction,
and covering defect with
various flaps
Excision of lesion, fibrotomy,
coronoidectomy, all 3rd molar
extraction, and covering defect
with various flaps
Excision of lesion with
effective safety margin
with neck dissection

3040

Intraoperative mouth
opening (mm)

The decrease in the interincisal

distance in the range of 510 mm
after 2 years of follow-up

Oral Maxillofac Surg (2015) 19:201207

where it comes in contact for a long period of time. So we give

a score to the involved site in order of progress of the disease.
It clears the stage and severity of the disease with regards the
site progression.
We have seen that as the fibrosis increases, there is progressive reduction in mouth opening of the patient. The severity of this trismus can be assessed with measurement of
interincisal mouth opening. Trismus not only affects the
speech but also the occlusal chewing function of the patient
which makes it more debilitating. In our study, we tried to
complement the interincisal mouth opening with the radiographic measurement. This interincisal mouth opening is correlated with the radiographic finding and put forth in mouth
opening and trismus severity index.
The next criterion we considered for the scoring is the
severity of fibrosis. The fibrosis sets the base for all the
symptoms we come across, so there is a need to understand
its extension. In the initial mild fibrosis, symptoms are insignificant while they become more aggressive as fibrosis advances. So we scored fibrosis according to three different
grades.
In oral submucous fibrosis, because of severe fibrosis,
trismus is produced in which the patient get deprived of
regular diet and nutrition. Because of inability to open the
mouth, the oral hygiene cannot be maintained which may
favor the malignant changes in the mucosa (Fig. 2). The
presence of other premalignant condition makes the mucosa
more prone to undergo dysplastic changes. The presence of
malignancy changes the treatment protocol which affects the
further prognosis extensively.
So as mentioned above, we consider all four factors, site
and its number, mouth opening, severity of fibrosis, and
malignant transformation, and proposed a new scoring index
to promptly decide the stage and severity of the disease. We
set five different groups according to the disease progression
with scoring mentioned above. We used these staging criteria
in treatment and set new algorithm in the management of oral
submucous fibrosis.
In our study, we considered 100 patients and divided
them into five groups of treatment as mentioned above.
All the patients were followed for 2 years regularly. Of
these 100 patients, group I (43 patients) patients were
with a score of 13 and were treated with nutritional
supplements and topical ointment and advised vigorous
mouth opening exercise. All patients showed satisfactory
increase in mouth opening of about average 34 mm
within 1530 days. In group II, patients with a score of
67 were treated with intralesional injections, antioxidant and nutritional supply, and physiotherapy; then we
found an average increase of mouth opening about
average of 56 mm within the period of 23 months.
We treated 22 patients of group III and group IV with
surgical management. In this surgical management, we

206
Table 5 Demonstration
of different treatment
modalities used

Oral Maxillofac Surg (2015) 19:201207

Scoring index

Stages

03

Group I

No. of patients

Mode of treatment

43

Antioxidants, topical
steroids, physiotherapy

M=40
67

Group II

F=03
30
M=22

910

Group III

F=08
13
M=11
F=02

1112

Group IV

9
M=7
F=2

13

Group V

5
M=4

Injectional steroids and

physiotherapy
Fibrotomy, coronoidectomy,
3rd molar extraction,
nasolabial flap or buccal
fat pad
Fibrotomy, coronoidectomy,
3rd molar extraction, nasolabial
flap or buccal fat pad along with
excision of lesion
Excision of lesion along with radical
neck dissection

F=1

treated the patients with bilateral fibrotomy followed by

reconstruction of fibrotomy defect with various flaps
like nasolabial flap, buccal fat pad, and collagen membrane. Depending upon the extent of fibrous bands,
when the fibrous bands extend anteriorly up to the
corner of mouth which requires long length flap, we
used nasolabial flap, while buccal fat pad is used only
for posteriorly located fibrous bands in the retromolar
trigone area. We used collagen membrane when other
pedicled flap or graft harvest is not possible. Postoperatively, all patients were prescribed with antioxidants
and were advised for vigorous mouth opening exercise
from the fifth postoperative day. We found an almost
satisfactory result with improvement in mouth opening
and chewing function in about 90 % of cases. In group
V, five patients were managed with radical surgery
consisting excision of the lesion using safety margin
as well as neck dissection. In the follow-up of 2 years,
we did not come across any recurrence (Table 5).

This particular study is based on the proposed scoring

system and innovative radiological method which is the novel
approach for treating OSMF, as treatment depends upon various staging. It gives a uniform approach and is more effective, as it involves almost all the sites of the oral cavity and the
scoring system is based on the clinical parameters, and the
severity of the disease can be judged easily and thoroughly
with early detection and prevention of it getting transformed
into malignancy. Though the data included in this study is 100
patients with 2 years follow-up in a Central Indian population,
it should be extended to a larger geographical area for the
longer follow-up period. This scoring index system and stages
will definitely help to decide the particular treatment the
patient of that category needs to get better result and better
prognosis. Because of pinpoint pathophysiology for the progression and establishment of disease is not clear, definitive
treatment cannot be employed arbitrarily. Hence, this staging
system has been proposed.

Conclusion

Fig. 2 Clinical photograph illustrating malignant changes in the

retromolar trigone on right side

A treatment protocol based on oral submucous fibrosis

scoring index for the patients of different groups has been
advocated with 2 years follow-up in this study. The results
and prognosis of the disease process of patients who have
been treated by this scoring index system based on clinical, radiological, and histopathological gradation are
more predictable. This particular scoring index system
for the oral submucous fibrosis can be used as a definitive
and uniform tool in the successful management of oral
submucous fibrosis.

Oral Maxillofac Surg (2015) 19:201207

207

Conflict of interest None.

5.

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