RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION

1. /

Name of the candidate and address

/
DR. LAXMI G DODDAMANI,
POST GRADUATE STUDENT,
DEPARTMENT OF ORAL MEDICINE
AND RADIOLOGY,
GOVERNMENT DENTAL COLLEGE & RESEARCH INSTITUTE,
BANGALORE- 560002
2. /
Name of the Institution
/ GOVERNMENT DENTAL COLLEGE &
RESEARCH INSTITUTE,
BANGALORE.
3. /

Course of the study and subject

/ MASTER OF DENTAL SURGERY
ORAL MEDICINE AND RADIOLOGY
4. /

Date of Admission to course

/ 01.06.2011
5. / Title of the Topic:
/ “A COMPARATIVE STUDY ON
DIODE LASER AND TOPICAL TRIAMCINOLONE
IN THE MANAGEMENT OF
ORAL LICHEN PLANUS ”
BRIEF RESUME OF INTENDED WORK.
6.1. Need for the study:
Oral Lichen Planus is a most common mucocutaneous lesion having potential for malignancy of about 0.5%, which can occur in any age group and with female predominance of 2:1.1
The etiology of Oral Lichen Planus is multifactorial. Current data suggests that OLP is a T- cell mediated autoimmune disease in which dysregulation of T-lymphocyte function results in damage to, or destruction of basal cells of the surface epithelium. Epidemiological, histological & immunological data indicates an immune pathogenesis.2
There have been various forms of Oral Lichen Planus described by Andreason: reticular, papular, plaque, atrophic, erosive & bullous with greater malignant transformation potential for atrophic and erosive forms of OLP.3 In many patients the onset of OLP is insidious & patients are unaware of their condition. The most predominant clinical feature of OLP is burning sensation to hot or spicy foods. Some patients report roughness, pain , white or red patches or ulceration on the oral mucosa.1
Several treatments like topical or systemic corticosteroids, topical immunosuppressives (tacrolimus,retinoids & cyclosporines)2 and surgical removal have been tried to treat OLP, however OLP is frequently resistant to the therapy. Topical corticosteroids have shown good result in the management of OLP with known side effects on prolonged use.5
Recently there has been much excitement and controversy over the use of laser in Oral medicine. Dental lasers can be applied to many fields in dental research and its application on the diagnosis and treatment of soft tissue lesions have been established. Diode laser provide greater benefit over many other lasers because of its small size and range of spectrum that is transmitted through fiberoptics. So it can be used in different locations. Many researchers have found that diode laser can be used to eliminate benign, premalignant lesions of the oral soft tissues.
Review of literature shows not many studies on diode laser in management of Oral Lichen Planus and no such study is conducted in India . Hence the need for the study is felt.
6.2 Review of literature:
1. A study was conducted on “efficacy of topical retinoic acid compared with
Topical Triamcinolone acetonide in the treatment of oral lichen planus” at Iran in
2004 by M. Sahebjamee , M. Amanlou and M. Bakhshi. In this study 60 patients
were recruited into 2 groups. Group A receiving topical triamcinolone (0.1%)
ointment and GroupB receiving topical retinoic acid (0.05%). The patients were
instructed to apply the medication 4 times daily for 4 weeks by means of a finger.
Signs and symptoms were evaluated according to the criteria set by Tel Aviv-
Francisco and Thongprasom. The study concluded that topical application of
triamcinolone acetonide 0.1% in oral base is safe and more effective treatment for
oral lichen planus than retinoic acid.4
2. A study on “management of oral lichen planus using diode laser(980). Aclinical
study.” was conducted on 25 patients affected by OLP at Cario, in 2005 by Mona
Soliman et.al. patients were treated by diode laser 980nm in 8w power in
defocused continuous mode under LA. Post operative complications evaluated
using VAS, showed mild to moderate pain, edema & functional disturbance which
were returned to normal at the end of 2 weeks, showing marked clinical
improvement as well as high degree of patient acceptance for this new modality
treatment.5
3. A study was conducted on “The comparison of efficacy of adcortyl ointment and
topical tacrolimus in treatment of erosive oral lichen planus” at Iran in 2007 by
Arash Azizi and Shirin Lawaf. Sixty patients with histologically confirmed oral
lichen planus were recruited into two groups. Group A consisted of thirty patients
who received adcortyl ointment (triamcinolone in orabase), and Group B included
thirty patients who received 0.1% topical tacrolimus ointment (Elidel). Patients
were instructed to apply the medication on the lesions 4 times a day for 4 weeks.
Pain scores and severity scores were assessed at each visit. Results showed no
significant differences between the two groups following treatment.6
4. A study on “effect of low-level laser irradiation on unresponsive oral lichen
planus : early preliminary results in 13 patients” conducted in Turin, Italy in 2010,
the investigators studied a prospective cohort of 13 patients affected by OLP.
Patients were exposed to a 904 pulsed diode laser 4J/cm2 energy densi/min. The
results detailed a significant reduction in lesion size & in reported pain. No
reported complications or therapy side effects were observed in any of the patients
treated.7
5 “A comparative pilot study of Lower Intensity Laser versus topical corticosteroid in
the treatment of erosive-atrophic OLP” was conducted in Iran in2011. 30 patients
with erosive-atrophic OLP were randomly allocated into 2 groups. The
exprerimental groups consisted of patients treated with 630nm diode laser & the
control group consisted of patients treated with topical corticosteroid. The
rensponse rate was defined using VAS of the lesion. The study demonstrated that
LILT was as effective as topical corticosteroid therapy without any adverse
effects.8
6.3. Aims and Objectives of the study:
1.  To assess the feasibility of diode laser in management of Oral Lichen Planus.
2.  To assess the symptoms of OLP before and after treatment with diode laser and topical triamcinolone.
3.  To compare the efficacy of diode laser and topical triamcinolone in the management of OLP.
Materials & methods
50 patients aged 20-60 years with symptomatic bilateral Oral Lichen Planus reporting to the department of Oral Medicine and Radiology, Govt Dental College and Research Institute, Bangalore will be selected for the study based on WHO selection criteria.9 Oral Lichen Planus will be diagnosed clinically and histologically.
Before inclusion into the study details of the study will be explained to the patients & written informed consent will be obtained. A detailed case history, thorough clinical & oral examination will be carried out & recorded in a case history performa. Patients on any medications are instructed to stop the medication one month before topical triamcinolone and three months before laser treatment.
In this study 50 patients with bilateral Oral Lichen Planus are recruited into two groups. Group I with Oral Lichen Planus of right buccal mucosa receiving topical triamcinolone (0.1%) ointment and Group II with Oral Lichen Planus of left buccal mucosa receiving laser treatment.
Group I patients will be instructed to apply the topical triamcinolone (0.1%) ointment on the lesions of right buccal mucosa four times daily for 4 weeks by means of a finger. The signs and symptoms will be evaluated after 1, 2, 3 and 4 weeks of treatment.
Group II patients with site of lesion over the left buccal mucosa will be subjected to field block infiltration local anesthesia. Taking all safety measures the lesion will be irradiated by 980nm pulsed diode laser (4-6J/cm2 energy density /min) The laser will be guided with an optic fiber diameter 400mm, until blanching of the treating area(photocoagulation). Based on the extension of the lesion 2-3 applications will be made.Patients will be examined after 3days, one, two & four weeks after laser irradiation to assess healing process & post operative complications and examined after six months for recurrence.
Signs and symptoms will be evaluated before starting therapy and at the end of every week. The symptoms will be scored from 0 – 100 according to the criteria set by Tel Aviv – San Francisco scale(Table.1) and signs will be scored from 0 -5 according to the criteria set by Thongprasom et al.(Table. 2)
Table 2. Symptoms stage by Tel Aviv-San Francisco (TASF) scale
Stage / Symptoms
100
75
50
25
0 / Asymptomatic
Low level of symptoms, does not interfere with usual daily activity
Symptoms interfere with regular daily activity
Sore and painful; greatly interferes with regular daily activity
Impossible to live with the severe symptoms
Table 1. Sign stage by Thongprasom
Stage / Signs
Score 5
Score 4
Score 3
Score 2
Score 1
Score 0 / White striae with atrophic area less than 1 cm2
White striae with atrophic area less than 1 cm2
White striae with atrophic area less than 1 cm2
White striae with atrophic area less than 1 cm2
Mild white striae, no erythematous area
No lesion, normal mucosa
Post operative complications such as pain, swelling and functional disturbance after laser treatment will be graded from 0-10 according to the following.
1 – 2 No post operative complications
3 – 5 Mild post operative complications
5 – 7 Moderate post operative complications
7 – 10 Severe post operative complications
The results obtained will be subjected to statistical analysis.
INCLUSION CRITERIA
1. Patients with age group between 20-60 years.
2. Patients with OLP involving bilateral buccal mucosa.
3. Patients diagnosed as OLP after histopathological investigation.
4. Patients not under any medication for OLP from last 3 months.
EXCLUSION CRITERIA
1. Patients above 60 years of age.
2. Patients with other mucosal lesions.
3. Patients under anticoagulants, systemic steroids and immunosuppressive drugs.
4. Patients with carcinoma.
5. Pregnant or breast feading women.
6. Immunodeficiency or HIV patients.

7.3. Does the study require any investigations or interventions to be conducted on
patients or other humans or other animals? If so, please describe briefly
Yes.
Incisional biopsy will be taken from the site of lesion before treatment for
histopathological examination.

7.4. Has ethical clearance been obtained from your institution in case of 7.3?
LIST OF REFERENCES:
1. Boorghani M, Gholizadeh N, Zenouz A T , Vatankhah M , Mehdipour M ,
Oral Lichen Planus: Clinical Features, Etiology, Treatment and Management; A
Review of Literature. J Dental Research, Dental Clinics, Dental Prospects ,
2010; 4(1):3-9.
2. Kalmar J R. Diagnosis and Management of Oral Lichen
Planus. J California Dental Association. 2007; 35(6):405-411.
3. Andreasen J O. Oral lichen planus. 1. A clinical evaluation of 115 cases. J
OralSurg Oral Med Oral Pathol.1968;25:31-42.
4. Sahebjamee M , Amanlou M , Bakhshi M. Efficacy of topical retinoic
acid compared with topical triamcinolne acetonide in the management of oral
lichen planus. Acta Medica Iranica 2004; 42(2):108-113.
5. Soliman M , EL Kharbotly A, Saafan A. Management of oral lichen planus using
diode laser (980nm). A clinical study. Egyptian Dermatology Online Journal
2005; 1(1):3:1-12.
6. Azizi A, Lawaf S. The Comparison of Efficacy of Adcortyl Ointment
and Topical Tacrolimus in Treatment of Erosive Oral Lichen Planus.
JODDD 2007;1(3):99-102.
7. Cafaro A, Albanese G, Arudino PG, Mario C, Mazzati M, Broccoletti R. Effect of
low-level laser irradiation on unresponsive oral lichen planus:early preliminary
results in 13 patients. Photomed Laser Surg. 2010; 2:S:99-103.
8. Jajarm HH, Falaki F, Mahdavi O. A comparative pilot study of low intensity laser
versus topical corticosteroids in the treatment of erosive-atrophic oral lichen
planus. Photomed Laser Surg. 2011;29(6):421-5.
9. Rad M, Hashemipoor MA, Mojtahedi A, Zarei MR, Chamani G, Kakoei S, Izadi
N. Correlation between clinical and histopathologic diagnoses of oral lichen
planus based on modified WHO diagnostic Criteria. J Oral Surgery,OralMedicine,
Oral Pathology, Oral Radiology, and Endodontology. 2009;107(6):796-800.
9. / Signature of the Candidate
10. / Remarks of the Guide
11. / 11.1. Name and
Designation of Guide
11.2 Signature / DR. MUBEEN,
PROFESSOR AND HEAD,
DEPARTMENT OF ORAL MEDICINE AND
RADIOLOGY,
GOVERNMENT DENTAL COLLEGE
AND RESEARCH INSTITUTE,
BANGALORE.
11.3. Co-Guide
11.4 Signature / DR. VIJAYALAKSHMI,
ASSISTANT PROFESSOR,
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY,
GOVERNMENT DENTAL COLLEGE &
RESEARCH INSTITUTE,
BANGALORE.
/ 11.5 Co-Guide
11.6 Signature
11.7 Head of the
Department
11.8 Signature / DR. KRIPA JOHAR,
MASTER IN LASER DENTISTRY,
BANGALORE.
DR. MUBEEN,
PROFESSOR AND HEAD,
DEPARTMENT OF ORAL MEDICINE AND
RADIOLOGY,
GOVERNMENT DENTAL COLLEGE &
RESEARCH INSTITUTE,
BANGALORE.
12. / 12.1 Remarks of the Chairman and Principal
12.2 Signature:

7