jouranal

1. PRESENTED BY:
Dr. Ashish Soni
Guided By:
Dr. Sunil Sharma (Prof & HOD)

2. introduction
•Oral submucous fibrosis (OSMF) is a chronic, progressive,
debilitating disease of the oral mucosa involving the oropharynx and
rarely the larynx.
• The disease is characterized by blanching and stiffness of the oral
mucosa, trismus, a burning sensation in the mouth, and
hypomobility of the soft palate and tongue with loss of gustatory
sensation.
•It is associated with juxtaepithelial inflammatory reaction followed
by a fibroelastic change of the lamina propria and epithelial atrophy
leading to stiffness of the oral mucosa, causing trismus and inability
to eat.

3. Aims and objective
• Definitive therapy is not defined for the management of oral
submucous fibrosis (OSMF).
• The purpose of this study was to determine the efficacy of
aloe vera gel as an adjuvant to the following treatment options
in the management of OSMF.

4. Materials and Methods
Study settings and cases
• A double-blind, placebo-controlled, parallel-group randomized controlled
trial was conducted on 60 subjects with OSMF divided into medicinal
treatment and surgical treatment categories.
• Each category was randomly divided into groups A (with aloe vera, n ¼
15 per category) and B (without aloe vera, n ¼ 15 per category).
• Thirty patients with grade I and grade II OSMF were planned for
medicinal treatment, and 30 patients with grade III and grade IV OSMF
were planned for surgical treatment.

5. • The patients were selected, irrespective of age, sex, religion,
and socioeconomic status
• Patients with uncontrolled diabetes, compromised immunity,
and chronic infection were excluded from this study.
• Routine blood and urine investigations were done, and
radiographs were taken, to exclude any associated diseases or
pathology.
• Follow-up assessment for various symptoms was performed,
and results were analyzed using paired and unpaired Student t
tests

6. Management
• Patients were actively discouraged from consuming the identified
etiologic factors, such as pan masala, gutkha, betel quid, tobacco, and
other chronic irritants such as hot and spicy food.
• All patients underwent biopsy to confirm the diagnosis and also to
correlate the clinical and histopathologic findings.
• Medicinal treatment
• Patients planned for medicinal treatment were given submucosal
injections twice a week of hyaluronidase (1500 IU) diluted with 1 mL of
2% lignocaine (with 1:80000 adrenaline) for the first 3 weeks.
• This was followed by submucosal injection twice a week of
hyaluronidase (1500 IU) diluted in 4 mg dexamethasone and 1 mL of
2% lignocaine (with 1:80000 adrenaline) for the next 7 weeks.
• Massaging the cheek with the mouth closed, followed by physiotherapy
with a Heister mouth gag for 20 minutes, was done after the
submucosal injection.

7. Surgical treatment
• Under local or general anesthesia as required in the individual case, the
fibrous bands in the buccal mucosa were palpated and incised along the
occlusal line.
• A Heister mouth gag was then applied to achieve a maximal interincisal
opening of 35 mm, and coronoidectomy was done.
• Suitable graft (buccal fat pad, nasolabial flap, or collagen membrane) was
then placed over the mucosal defect.
• Physiotherapy with a wooden spatula from the fifth postoperative day, at
least 4 to 5 times a day, for a minimum of 6 months.
• Each treatment category (medicinal and surgical) was randomly divided into
2 groups, A and B, having an equal number of patients
• Group A patients were advised whereas no such advice was given to group
B patients to apply aloe vera gel.
• The 4 subgroups were labeled group A med, group A surg, group B med,
and group B surg.

8. • Outcome assessment
• The follow-up assessment of subjects was done on a twice-a-week
basis, whereas data were recorded on a weekly basis during the
medicinal treatment and monthly after the completion of the treatment,
up to 6 months.
• Surgically treated patients, postoperative follow-up was performed
monthly up to 6 months.

9. • . The criteria for assessment were as follows:
• the burning sensation of the mouth was measured on a linear scale
reading from 0 to 10, taking 5 as the default initial reading and
benchmark;
• mouth opening was measured (in millimeters) from the incisal-most point
of the labial surface of the upper central incisor to the incisal-most point
of the labial surface of the lower central incisor
• tongue protrusion was measured (in millimeters) from the incisal-most
point of the labial surface of the upper incisor to the tip of the dorsal
surface of the tongue on maximal protrusion.
• Suppleness and elasticity of the buccal mucosa were assessed based on
the distance (in centimeters) between the tips of the ear lobes on
maximal cheek blowing.

10. Statistical analysis
• The findings of various parameters were evaluated and
analyzed statistically using paired and unpaired Student t tests.
• Comparisons between group A and group B were done
separately for medicinally and surgically treated patients.
• A P value of .05 was considered statistically significant.

11. RESULTS:-
A total of 60 participants (53 men and 7 women) were included in
the study. The majority, 41 (68.3%), were 21 to 40 years of age.
Male predominance was found in both groups; in group A (n .30), 26
were men and 4 were women (6.5:1); in group B (n . 30), 27 were
men and 3 were women (9:1).

12. Comparison of the burning sensation of the mouth between
group A and group B in patients treated medicinally and
surgically.
Grp A Med:
beginning 5.0+ 0; 10th week
0.38 + 0.47 ; 6th month 0.26+
40
Grp B Med:
continuous decrease in
burning sensation, 2.23 +
1.14, after completion relapse
in reduction of burning
sensation to 2.96 + 1.96 until
the sixth month
Grp A Surg:
Significant decrease (5 + 0 to 3.66 + 0.97;) 1 month after Surgery. First month to
the sixth month gradual and continuous decrease.
Grp B Surg
(5 + 0 to 4.03 + 0.93) 1 month after surgery. First month to the sixth month
increased (4.03 + 0.95 to 4.23 + 0.75)

13. Comparison of mouth opening between group A and group B in
patients treated medicinally and surgically.
Grp A Med:
Pre-treatment mean
mouth opening 23.46
+ 5.37 mm, increased
by 13.74 mm from
initiation to the 6-month.
After the tenth week,
further increases were
not noted.
Grp B Med :
Pre-treatment mean mouth
opening 24.0 + 7.53 mm.
from initiation to the 6-
month (6 mm), after the
completion decrease (from
32.40 + 6.96 mm to 30.0 +
7.41 mm)
Grp A Surg:
Postoperative mean mouth opening after the first month was 37.46 + 2.50
mm. insignificant increase (37.46 + 2.50 mm to 38.93 + 3.32 mm) from the
first month after surgery to the 6-month follow-up
Grp B Surg
Postoperative mean mouth opening after the first month was 37.33 + 2.12.
considerable decrease (37.33 2.12 mm to 34.0 3.18 mm) during the same
period.

14. Comparison of tongue protrusion between group A and group
B in patients treated medicinally and surgically.
Grp A & Grp B
Med:
increased from 26.00 +
5.83 mm to 32.13 + 6.83
mm, amount was not
significantly greater than
the increase in group B
med (32.46 + 6.35 mm to
38.33 + 5.05 mm) from
the initiation to the
completion
that is, by the tenth week.
After completion of
medicinal treatment and
until the 6-month follow-up,
a decrease was found in
group B med (38.33 +
5.05 mm to 36.66 + 5.31
mm), compared with the
slight decrease (32.13 +
6.83 mm to 31.67 + 6.66
mm) in group A med
.
Grp A & Grp B Surg
the first month’s postoperative mean tongue protrusion was 22.86 + 5.08 mm in
group A surg and 24.2 + 5.83 mm in group B surg. There was an insignificant
increase (22.86 + 5.08 mm to 23.13 + 5.59 mm) in tongue protrusion from the first
month after the surgery to the sixth month in both surgical groups

15. Comparison of ear lobe distance on cheek blowing between
group A and group B in patients treated medicinally and
surgically.
Grp A & Grp B
Med:
Ear lobe distances on cheek
blowing in group A med
(27.36 + 2.32 cm to 28.73 +
2.58 cm) and group B med
(26.93 + 1.89 cm to 27.53 +
2.22 cm) after the
completion of medicinal
treatment were similar.
There was a considerable
increase in ear lobe distance
in group A med from initiation
to the third week (27.36 +
2.32 cm to 27.80 + 2.44 cm)
and from the sixth week to
the eighth week (28.07 + 2.52
cm to 28.52 + 2.56 cm)
compared with group B med
(from 26.93 + 1.89 cm to
27.03 + 1.91 cm in the first 3
weeks and from 27.33 + 2.10
cm to 27.50 + 2.19 cm in the
sixth to eighth weeks).
Grp A & Grp B Surg
Surgically treated patients, the results obtained with the mean ear lobe
distance were insignificantly different from 1 month to 6 months after surgery
between group A surg (26.53 + 2.2 cm to 27.10 + 2.46 cm) and group B surg
(27.96 + 2.72 cm to 27.53 + 2.81 cm)

16. Discussion
• Discontinuation of the habit is the first and foremost step before
treatment planning. The treatment employed in this study was first
suggested by Khanna and Andrade. According to them, patients
with an early stage of OSMF should be treated medicinally,
whereas patients with an advanced stage of OSMF should be
treated surgically
• Aloe vera is an emollient resin and a mannoprotein containing
many amino acids that have been called “wound-healing
hormones.” The polysaccharides in the gel of the leaves have
woundhealing, anti-inflammatory, anticancer, immunomodulatory,
and gastroprotective properties
• The medicinal treatment used in this study was suggested in 1985
by Kakar et al., who studied different combinations and regimens
and recommended that patients should be given a course of local
injection of hyaluronidase twice a week for the first 3 weeks,

17. • The findings in group B med for the burning sensation of the mouth
are similar to the findings of Katharia et al.,13 who used injection of
placental extract for 1 month in 22 patients and found a 40.21%
reduction in burning sensation, whereas in group A med the
reduction was as high as 92.4%. The findings of this study clearly
indicate that the use of aloe vera gel along with medicinal
treatment results in a remarkable improvement in the burning
sensation.
• The findings for mouth opening in group B med (i.e., improvement
of 35%) are similar to the findings of Katharia et al.,13 in which a
28.26% improvement with the treatment with Placentrex was
found. Haque et al.14 studied the effect of interferon-gama and
found a 42% gain in net mouth opening after treatment. This result
is similar to finding in group A med, in which the improvement was
60.5%, which is significantly higher than the improvement in group

18. • The groups with aloe vera gel application and without aloe vera
gel application showed insignificant difference in improvement in
tongue protrusion and had improvement levels similar to the
18.5% found after 1 month of treatment with Placentrex by
Katharia et al.13 and to the 26.3% found after antioxidant therapy
in a study by Gupta et al. We found that tongue protrusion
measures increased by 8.69% (26.0 to 28.26 mm) in group A med
in the first 2 weeks of treatment, compared with 2.68% (32.46 to
33.33 mm) in group B med, without further gains after completion
of medicinal treatment. These results indicate that topical aloe
vera gel may contribute to quicker improvement of tongue
protrusion and maintaining tongue protrusion achieved after the
completion of medicinal treatment.
• This study found a considerable increase of 1.6% (27.36 to 27.8
cm) in the ear lobe distance within the first 3 weeks of treatment

19. • Surgically treated patients
• In our study’s surgically treated patients, we found that all of the
grafts were well accepted. Complications such as flap loss, flap
avulsion, and wound dehiscence were not encountered.
Incidence of infection or necrosis of the graft was not found,
although the patients applying aloe vera gel had quicker healing,
better acceptance, and healthier appearance of the graft mucosa.
• In this study, a significant decrease of 26.8% (5.0 to 3.66) in
burning sensation of the mouth in group A surg from before the
surgery to 1 month after the surgery, compared with 19.4% (5.0 to
4.03) in group B surg, was found, which suggests a positive role
of aloe vera gel in the reduction of the burning sensation from the
time of surgery and during the first postoperative month.

20. • The mouth opening of 37.46 + 2.50 mm in group A surg and
37.33 + 2.12 mm in group B surg was maintained 1 month
after the surgery. After 6 months of follow-up, there was an
increase of 3.77% (37.46 to 38.93 mm) in mouth opening in
group A surg, whereas there was a considerable decrease of
8.92% (37.33 to 34.0 mm) in mouth opening in group B surg
• The observation in the aloe vera group of slight increase in
mouth opening indicates its importance in the prevention of
relapse of the improved mouth opening achieved after
surgery. The relapse in the mouth opening achieved after
surgery without the application of aloe vera gel is believed to
be because of the graft contracture during healing and the
recurrence of fibrosis.

23. This study shows that no single drug regimen can
provide complete relief in OSF. First and foremost
intervention includes intensive counselling and
cessation of the habit. Although reversal of fibrosis is
not possible, it is effective in relieving the symptoms.

24. • Conclusion
• In conclusion, these findings indicate that the aloe
vera gel was beneficial as an adjunct to medicinal
and surgical approaches in the treatment of OSMF.