Download 5. Chole RH et al. Review of drug treatment of oral

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA.
ANNEXURE – II
PROFORMA FOR REGISTRATION
OF
TOPIC FOR DISSERTATION
1
Name of the Candidate
and Address (in block letters)
DR. ANUSUYA G S
C/O DUNDAPPA M. SAVALAGI
“SHARAN KRUPA”,PLOT NO.17
KRISHNA NAGAR,KUSNOOR ROAD,
BEHIND GULBARGA UNIVERSITY
GULBARGA-585106.
2
Name of the Institution
NAVODAYA DENTAL COLLEGE AND HOSPITAL
P.B. No 26,NAVODAYA NAGAR
RAICHUR.-584103.
3
Course of study & Subject
MASTER OF DENTAL SURGERY ,
ORAL MEDICINE AND RADIOLOGY .
4
Date of Admission to Course
28 May 2012.
5
Title of the topic
COMPARE THE EFFECTIVENESS OF LYCOPENE
–A CAROTENOID ANTIOXIDANT WITH
INTRALESIONAL STEROID INJECTIONS IN
PATIENTS WITH ORAL SUBMUCOUS FIBROSISA CLINICAL STUDY.
6.
BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY:
Oral submucous fibrosis is a chronic, premalignant condition of the oral mucosa first
described by Schwartz in 1952.Pindborg(1966) defined OSMF as” an insidious oral 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 juxta-epithelial
inflammatory reaction followed by fibroelastic change of the lamina propria, with epithelial
atrophy leading to stiffness of the oral mucosa and causing trismus and inability to eat”1.
Many treatments have been tried An ideal treatment is that reverses the changes in
mucosa and cures OSMF.
The role of free radicals in the various oxidation processes in the body has led to the
identification of antioxidants in inhibiting and reversing the disease process. The mode of action
of antioxidants may involve the stimulation of the immune system or direct action on the tumour
cells. They are antimutagenic, antimitogenic and operate by common mechanism of breaking
free radical chain reactions2.
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( red carrots, watermelons, papayas) It has been shown to have several potent
anticarcinogenic and antioxidant properties and has demonstrated profound benefits in
precancerous lesions such as leukoplakia.2.
The main aim and objective of this study was to evaluate the clinical response of OSMF
to the antioxidant, lycopene as conservative means in comparison to intralesional steroid
injections.
6.2 REVIEW OF LITERATURE:
In a study it was shown that OSMF increased with duration, frequency and style of
chewing habits for longer duration and swallowing tobacco or gutkha without spitting1.
In a study fifty-eight patients with oral submucous fibrosis were randomly divided into 3
groups, evaluated weekly over a 2-month period. Patients of group A (n = 21) received 16 mg of
lycopene, those of group B (n = 19) received 16 mg of lycopene along with biweekly
intralesional steroid injections, and those of group C (n = 18) were given a placebo.
Mouth-opening values for the patients showed an average increase of 3.4 mm, 4.6 mm, and 0.0
mm for patients in groups A, B, and C, respectively .It was suggested that lycopene can and
should be used as a first line of therapy in the initial management of oral submucous fibrosis2.
In a study 12 patients clinically and histologically diagnosed with oral submucous
fibrosis,were given Lycored capsule containing 100% lycopene 2mg orally twice for 3 months.
Responses were assessed clinically, by bimonthly evaluation, examination, photographs and
biopsy at the end of the treatment.Clinical and histological improvement was observed in
various parameters and also no significant toxicity to lycopene was encountered3.
Another study on lycopene stated that Lycopene played a significant role in cure of
various diseases due to its antioxidant and cancer preventing properties4.
In a study it was it was suggested that Lycopene is a powerful antioxidant and has a
singlet-oxygen-quenching ability twice as high as that of beta-carotene and ten times higher than
that of alpha-tocopherol. Patients who received 16 mg of lycopene showed an average increase
of 3.4 mm mouth-opening. There were no reported instances of side effects or intolerance to
lycopene. The investigators suggested that lycopene is a safe and reliable drug and should be
used as a first line of therapy in the initial management of oral submucous fibrosis5.
6.3 OBJECTIVES OF THE STUDY:
1. To evaluate the clinical response of OSMF to the antioxidant, lycopene as conservative
means in comparison to intralesional steroid injections.
2. To evaluate the effect of treatment on burning sensation and mouth opening.
7
MATERIALS AND METHODS:
7.1 SOURCE OF DATA:
7.1.1 Type of study: Prospective study.
7.1.2 Source: Patients attending the Department of Oral Medicine And Radiology in Navodaya
Dental College and Hospital, Raichur.
7.2 METHOD OF COLLECTION OF DATA: (including sampling procedure
if any).
Sampling technique: Random
Sample size:
Study sample comprises of 40 patients divided into two groups:
 Group A - 20 patients clinically diagnosed with OSMF receiving lycopene.
 Group B- 20 patients clinically diagnosed with OSMF receiving intralesional steroid
injections.
Sample selection:
Criteria for selection of subjects:
Inclusion criteria:
.
1. Patients who agree to quit arecanut , gutkha chewing habit and stop consuming spicy
food and ready for follow-ups.
2. Patients clinically diagnosed with OSMF.One of the following parameter will be
considered for inclusion
a. Positive history of chewing arecanut with tobacco, difficulty in swallowing and
chewing, burning sensation on eating hot and spicy food and restricted mouth
opening.
b.
Changes in oral mucous membrane including the presence of palpable fibrous
bands, blanching along with burning sensation and restricted mouth opening.
3. Group II and Group III patients as per Khanna J N and Andrade N N classification
(1995).
Exclusion criteria:
1. Patients suffering with any other systemic diseases or conditions.
2. Pregnant women.
3. Patients with OSMF with other precancerous lesions and conditions.
4. Group I and Group IVA and IVB patients as per Khanna J N and Andrade N N
classification (1995).
Methodology:
1. A standard proforma will be used to record the clinical signs and symptoms in all the
cases.
2. Informed consent will be taken from the patient.
3. Patient will be advised to quit the habit of chewing arecanut, gutkha and spicy food.
4. All patients will undergo oral prophylaxis procedure to remove extrinsic stains. This will
inform the investigator whether the patient resumed the habit.
5. History of the personal habits in regard to duration, frequency and symptoms will be
recorded particularly burning sensation and mouth opening.
6. Clinical examination of the patient will be done under artificial light which includes both
intra-oral and extraoral examination.

Under intraoral examination findings such as blanching of oral mucosa, presence of
vesicles or ulcers, palpable bands, limitation of tongue movements, and extension
into the oropharynx will be noted.

Under extra-oral examination, patients mouth opening will be measured with
reference to interincisal points between upper and lower central incisors with
verniers callipers.

Burning sensation will be assessed using Visual Analog Scale (VAS) ranging from
1-10 where 1 indicates no pain and 10 indicates maximal pain perceived.
7. After history taking and clinical examination patients as per the classification given by
Khanna J N and Andrade N N in 1995 for the surgical management of OSMF patients will
be divided into Group I, II, III and IV 6.
Group I:Very early cases
•
Common symptom burning sensation in mouth
•
Acute ulceration and recurrent stomatitis
•
Not associated with mouth opening limitation
Group II-Early cases:
•
Buccal mucosa appears mottled and marble like
•
Widespread sheets of fibrosis palpable
•
Interincisal distance of 26-35mm .
Group III:Moderately advanced cases:
•
Interincisal distance of 15-25mm
•
Buccal mucosa pale and firmly attached to underlying mucosa
•
Atrophy of vermillion border
•
Fibrous bands palpable at soft palate,pterygomandibular raphae and anterior
faucial pillars.
Group IVA:Advanced cases

Trismus is severe,with an interincisal distance of less than 15mm and extensive
fibrosis of all the oral mucosa.
Group IVB:

Advance cases with premalignant and malignant changes

Hyperkeratosis,leukoplakia and squamous cell carcinoma can be seen.

Only Group II and Group III patients will be taken for the study

Group I cases will not be taken because they are not associated with mouth
opening limitation

Group IV cases will not be taken because they have severe trismus (mouth
opening less than 15mm),so location of the site of injection will be difficult.
8. Group A and Group B will have 20 patients each.(10 of group II &10 of group III)
TOTAL NO.OF PATIENTS
GROUP II
GROUP III
GROUP A-20
10
10
GROUP B-20
10
10

Patients with Group A will be given commercially available LYCORED capsules(Jagson
Pharamaceuticals Ltd, India) that contains 100% lycopene (4000mcg) as natural Lyco-oMato, with zinc(7.5mg) as sulphate monohydrate, and selenium(35mcg) as
monohydrated dioxide.

Capsules will be given orally 16mg/day in 2 divided doses for 2 months where each
capsule contains 4 mg of lycopene. (2 capsules of 4mg in the morning and 2 capsules of
4mg in the evening).

Patients in group B will be given intralesional injections of steroid KENACORT(Abbott
Pharameceuticals, India),that contains triamcinolone acetonide 10 mg/ml and benzyl
alcohol(preservative),mixed with 0.5ml of xylocaine, once every week for 2 months.
Injections will be given submucosally in retromolar area, adjacent soft palate and other
affected areas,0.5 ml on either side with insulin syringe with sterile precautions.

Other than above mentioned medications, no other medicines will be prescribed to the
patient.
9.
All the patients will also be advised to do the mouth opening exercises.
10. Mouth opening and burning sensation will be recorded in both the groups every 2 weeks
until treatment is completed and compared between same stages of each group.
Statistical analysis:
Data will be analysed applying proportions and Chi-Square tests, Students T test will be
used to compare quantitative measurements between the two groups.
Instruments: Mouthmirror, probe, Visual analog scale, Vernier callipers, insulin syringe,
gloves, mouth mask.
Duration of the study: 1.5 years from Dec 2012 to May 2014.
7.3 Does the Study require any investigation or intervention to be conducted on
patients or other human subject or animals? If so, please describe briefly.
Yes, intralesional steroid injections will be given in GroupII and GroupIII patients.
7.4 Has Ethical Clearance been obtained from your Institution?
YES.
8.
LIST OF REFERENCES:
1. Reddy V, Wanjawari PV, Reddy N ,Reddy P. Oral Submucous fibrosis: Correlation of
clinical grading to various habits. Int J Clin Dent 2011;3(1):21-24
2. Kumar A, Bagewadi A, Keluskar V, Singh M. Efficacy of lycopene in the management
of oral submucous fibrosis. J Ora Sur, Ora Med, Ora Path, Ora Rad & End 2007
Feb;103(2):207-213
3. Gowda BBK, Yathish TR, Sinhasan SP, Kumar NH, Somayaji P. The response of
Lycopene to oral Submucous Fibrosis-A Carotenoid antioxidant: A clinicopathological
study. J Clin and Diag Res 2011 Aug;5(3):000-000
4. Nisheeth et al “Lycopene,a promising antioxidant” JIAOMR 2007;19(4):485-63
5. Chole RH et al. Review of drug treatment of oral submucous fibrosis. J Oral Onco
2012May; 48(5):393-98
6. Karemore VT, Karemore V A. Etiopathogenesis and Treatment strategies of oral
submucous fibrosis. JIAOMR 2011Oct-Dec;23 (4):598-602
9
Signature of the Candidate
10
Remarks of the Guide
11
Name and Designation (in block
letters)
11.1 Guide
I am willing to guide Dr ANUSUYA in her dissertation
titledCOMPARE THE EFFECTIVENESS OF LYCOPENE
–A CAROTENOID ANTIOXIDANT WITH
INTRALESIONAL STEROID INJECTIONS IN
PATIENTS WITH ORAL SUBMUCOUS FIBROSISA CLINICAL STUDY
Dr DNSV RAMESH
PROFFESSOR AND HEAD OF DEPARTMENT
ORAL MEDICINE AND RADIOLOGY
NAVODAYA DENTAL COLLEGE ,RAICHUR
Signature
11.2 Co-Guide
Signature
11.3 Head of Department
DR.VAJENDRA V. JOSHI
READER
DR. DNSV RAMESH
PROFFESSOR AND HEAD OF DEPARTMENT
ORAL MEDICINE AND RADIOLOGY
NAVODAYA DENTAL COLLEGE ,RAICHUR
11.4 Signature
12
12.1 Remarks of the Chairman
and Principal.
12.2 Signature