10.

5005/jp-journals-10011-1293
S Sunderraj et al
ORIGINAL ARTICLE

An in vivo Study to determine the Efficacy of Lycopene

as compared to Multivitamin Preparation in the
Treatment of Oral Submucous Fibrosis
S Sunderraj, Rohit Sharma, Vishal Agarwal, Praful Narang, YG Reddy, Amit Kumar Sharma

ABSTRACT
Objectives: The study was conducted to assess the efficacy of
lycopene in the treatment of oral submucous fibrosis (OSMF)
among patients visiting Dental College in Jaipur, Rajasthan,
aged 15 years and above.
Materials and methods: Twenty OSMF patients were randomly
divided into two groups A and B. Group A, patients received
combination of lycopene (16 mg) in divided doses. Group B,
patients received combination of multivitamin preparation.
Treatment outcome was evaluated on the basis of improvement
in symptom score, sign score. The statistical analysis was done
with SPSS software, version 11.5.
Results: The result showed that OSMF patients receiving
lycopene have more improvement in burning sensation and with
some improvement in mouth opening.
Conclusion: The observations and findings of the study clearly
indicate that efficacy of lycopene is higher compared to
multivitamin preparation.
Keywords: Treatment, Oral submucous fibrosis, Lycopene,
Multivitamin preparation.
How to cite this article: Sunderraj S, Sharma R, Agarwal V,
Narang P, Reddy YG, Sharma AK. An in vivo Study to
determine the Efficacy of Lycopene as compared to
Multivitamin Preparation in the Treatment of Oral Submucous
Fibrosis. J Indian Aca Oral Med Radiol 2012;24(3):190-193.
Source of support: Nil
Conflict of interest: None declared

INTRODUCTION
Oral submucous fibrosis (OSMF) has a very interesting
history. Sushruta, a renowned Indian physician who lived
in the era from 2500 to 3000 BC, had already recognized it
as a mouth and throat malady and had labeled it as Vidhari.
The features of which were described as a progressive
narrowing of the mouth, blanching of the oral mucosa, pain
and burning sensation on taking food, hypomobility of the
soft palate and tongue, loss of gustatory sensation and
occasional mild hearing impairment due to the blockage of
the eustachian tube. There has been nearly no change in
these symptoms till today.1-4
The World Health Organization (WHO) definition for
an oral precancerous condition A generalized pathological
state of the oral mucosa associated with a significantly
increased risk of oral cancer, accords well with the
characteristics of OSMF. The disease is predominantly seen

190

in India, Bangladesh, Sri Lanka, Pakistan, Taiwan, Southern

China and other countries.5-8
People visiting Outpatient Department, NIMS Dental
College, Jaipur, Rajasthan, commonly use areca nut and
tobacco products like mawa, pan, gutkha and khaini, etc.
and some of them were suffering from OSMF.
Lycopene is a safe antioxidant of utmost importance.
Lycopene is a bright red carotene and carotenoid pigment
and a phytochemical found in tomatoes and other red fruits
and vegetables, such as red carrots, watermelons and
papayas. Preliminary research has shown an inverse
correlation between the consumption of tomatoes and cancer
risk. It has been shown to have several potent anticarcinogenic and antioxidant properties and has demonstrated
profound benefits in precancerous lesions, such as
leukoplakia. Lycopene exhibits the highest physical
quenching rate constant with singlet oxygen.9,10
The main aim and objective of this study was to evaluate
the clinical response of OSMF to the antioxidant lycopene.
MATERIALS AND METHODS
A cross-sectional study was conducted in Outpatient
Department, NIMS Dental College and Hospital, Jaipur,
Rajasthan. Total of 20 patients diagnosed with OSMF were
divided equally into treatment groups A and B.
Subjects aged 15 years and above who were willing to
participate were included in the study. Subjects with any
systemic diseases and malignancy were excluded from the
study. An ethical clearance was obtained from ethical
committee of NIMS Dental College and Hospital, Jaipur.
Oral consent was obtained from each participant prior to
the study.
The examination was done by principal examiner and
trained recording clerk was present to record the data in the
predesigned proforma. The clinical diagnosis of OSMF was
made when subject showed characteristic features of OSMF,
blanching and stiffness of the oral mucosa, presence of
palpable bands in the buccal or labial mucosa and difficulty
in mouth opening and protruding the tongue.11-13
In this study, the clinical parameters that were evaluated
are as follows:14
1. Symptomatic relief in the form of absence of burning
sensation in the mouth and spontaneous healing of the
ulcers when present.
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JIAOMR
An in vivo Study to determine the Efficacy of Lycopene as compared to Multivitamin Preparation in the Treatment

2. Change in the color of the mucosa and its texture.

3. Improvement in mouth opening.
Patients in group A received lycopene (LycoRed,
Jagsonpal Pharmaceutical Company, New Delhi, India)
capsule containing 100% natural lycopene with zinc,
selenium and added phytonutrients, which was given
16 mg in two divided doses and those in group B received
multivitamin preparation (Revital, Ranbaxy Laboratories
Limited) twice daily for a time period of 4 months from
July 2010 to October 2010. Treatment responses are assessed
clinically by bimonthly evaluation with clinical examination.
The responses were classified as follows:14
1. Complete
When the color of the mucosa turned from blanched
white to normal pale pink.
When there was a definite improvement in the
burning sensation, which reduced to an appreciable
extent.
When there was an increase in the mouth opening
which ranged from 2 to 3 mm.
2. Partial
When there was a partial improvement in the above
said signs and symptoms and the mouth opening was
increased by 0.4 to 1 mm.
3. Stable
When there was no response and no improvement.
4. Disease progression
When there was a progressive increase in the signs
and symptoms in spite of having undergone the
treatments.
Armamentariums used were measuring calliper, sterile
mouth mirror, explorer, tweezers, kidney tray instrument
pouch, savlon, disposable surgical latex gloves, disposable
mouth mask and questionnaires. The statistical analysis was
done with SPSS software, version 11.5.
RESULTS
Table 1 shows distribution of patients in group A which
were treated with lycopene. Out of all the patients there

were seven male patients and three female. The patients

treated with lycopene, eight patients showed complete
response to the treatment and two patient showed partial
responses.
Table 2 shows distribution of patients in group A which
were treated with lycopene. Out of all the patients there
were six male patients and four female patients. The patients
treated with multivitamin preparation, three patients showed
complete response to the treatment and four patient showed
partial response and three patients were stable.
Table 3 shows the response data of patients in groups A
and B which were treated with lycopene and multivitamin
preparation. Of the patients treated with lycopene, 80%
showed complete response to the treatment and 20% patient
showed partial response compared with patients in group B
which showed 30% complete, 40% partial and 30% stable
response.
DISCUSSION
OSMF is a disease associated with the habit of betel nut
chewing and it is characterized by extensive collagen
deposition in the soft tissues of the mouth. Various
researchers, in their studies on the mutagenic properties of
areca nuts have found that the constituents and the extracts
of the nuts cause chromosomal aberrations and DNA
damage. In the review of literature, starting from Pay Master,
1959 to JN Khanna, 1995, everyone is of the opinion that
submucous fibrosis is a precancerous condition with a
malignant transformation rate which varies from 3 to
7.6%.15-17
The present study shows improvement in mouth opening
and burning sensation in patients which were treated with
lycopene compared with patient receiving multivitamin
preparation. The patients treated with lycopene showed 80%
complete response to the treatment and 20% patient showed
partial response.
OSMF is an incurable disease. No treatment modality,
either surgical or medical has been successful in completely

Table 1: Patients of group A (lycopene) having OSMF: Pretreatment and post-treatment

S. no.

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

Age/sex
(mm)
17/M
25/M
27/M
20/F
29/M
37/M
31/F
34/M
33/M
22/F

Mouth opening
Prior to treatment
(mm)

Post-treatment
(mm)

27
15
20
15
18
17
29
19
20
18

30
17
22
16
20
19
33
20
21
20

Improvement
(mm)
3
2
2
1
2
2
4
1
1
2

Burning sensation
Prior to
treatment

Post-treatment

Response

Subsided
Subsided
Subsided
Reduced
Subsided
Subsided
Subsided
Reduced
Subsided
Subsided

Complete
Complete
Complete
Partial
Complete
Complete
Complete
Partial
Complete
Complete

Severe
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Moderate
Severe

Journal of Indian Academy of Oral Medicine and Radiology, July-September 2012;24(3):190-193

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S Sunderraj et al
Table 2: Patients of group B having OSMF: Pretreatment and post-treatment
S. No

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

Age/sex
(mm)

Mouth opening
Prior to treatment
(mm)

Post-treatment
(mm)

23
17
20
18
18
17
21
19
21
17

25
17
21
20
18
17
23
20
22
18

18/M
21/F
27/M
21/F
29/M
41/M
31/F
23/M
32/M
20/F

Improvement
(mm)
2
No
1
2
No
No
2
1
1
1

Burning sensation
Prior to
treatment
Moderate
Moderate
Severe
Mild
Severe
Severe
Mild
Moderate
Mild
Severe

Posttreatment

Response

Subsided
Reduced
Reduced
Subsided
Reduced
Reduced
Subsided
Reduced
Subsided
Reduced

Complete
Stable
Partial
Complete
Stable
Stable
Complete
Partial
Partial
Partial

Table 3: Response data

Response
Number evaluable
Complete response
Partial response
Stable
Progression

Number of patients
Group B

Group A

Group B

10
08
02

10
03
04
03

80%
20%
Nil
Nil

40%
60%
30%
Nil

eliminating the disease. In view of the strong relationship

between oral cancer and precancerous lesions, chemoprevention is said to be feasible and practicable.
A safe and simple mode of treatment as described in this
study, along with proper habit restriction is required in
OSMF to ensure that the progression of the disease is
retarded and that maximum relief is obtained by the
patient.16,17
Other treatment modalities are extensive and include
the use of micronutrients and minerals, carbon dioxide
laser, pentoxifylline, interferon-, turmeric, hyalase,
chymotrypsin and collagenase. As fibrosis cannot be
reversed, when mouth opening is severely limited surgical
interventions, such as myotomy, coronoidectomy and
excision of fibrotic bands, are required. Reconstruction
using such techniques as buccal pad flap, superficial
temporal flap and forearm flap can also be performed.
Alternative procedures, such as insertion of an oral stent,
physiotherapy, local heat therapy, mouth exercises using
acrylic carrots and ice cream sticks, have been tried with
variable rates of success. In most cases, depending on the
stage of disease and extent of oral involvement, therapy
consisting of a combination of the above-mentioned drugs
and surgery might be used.18-20
CONCLUSION
A positive clinical response was seen in study groups in
this study when compared with multivitamin. Lycopene was
seen to be efficacious as a safe, reliable drug in the

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Percentage

Group A

management of OSMF. In contrast to other management

modalities for submucous fibrosis, it offers a noninvasive
option that yields significant improvements in the symptoms
as well as objective signs of the condition.
This was a short-term study with a small sample size.
A long-term study with a larger sample size with all the
above variables being taken into consideration would be
necessary to get a clear picture about the utility of the drug.
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ABOUT THE AUTHORS

S Sunderraj (Corresponding Author)
Principal, Professor and Head, Department of Oral Medicine
and Radiology, Maharana Pratap College of Dentistry
and Research Center, Gwalior, Madhya Pradesh, India
e-mail: dr.s.sunderrajomr@gmail.com

Rohit Sharma
Senior Lecturer, Department of Oral Medicine and Radiology, NIMS
Dental College and Hospital, Jaipur, Rajasthan, India

Vishal Agarwal
Professor, Department of Conservative Dentistry, NIMS Dental
College and Hospital, Jaipur, Rajasthan, India

Praful Narang
Senior Lecturer, Department of Prosthodontics, NIMS Dental College
and Hospital, Jaipur, Rajasthan, India

YG Reddy
Principal, Professor and Head, Department of Orthodontics, NIMS
Dental College and Hospital, Jaipur, Rajasthan, India

Amit Kumar Sharma

Senior Lecturer, Department of Oral Surgery, Jaipur Dental College
Jaipur, Rajasthan, India

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