Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)
Phase: NA
Conditions: Erosive Oral Lichen Planus
Sponsor: Alexandria University

  
 
 
 
 
Faculty of Dentistry
 
Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral 
Radiology  
 
 
 
Research proposal plan to obtain a master's degree in oral medicine 
 
Titled 
 
EVALUATION OF DIODE LASER AND TOPICAL STEROID 
THERAPY IN THE TREATMENT OF EROSIVE ORAL 
LICHEN PLANUS.  
(A RANDOMIZED CONTROLLED CLINICAL TRIAL)  
 
Academic year 
2021/2022 
 Protocol ID: 0369-01/2022 
Researcher: Reem Kamal Mohamed Abdelaziz
 
 

  
 
     
                                                                                                                                             
Faculty of Dentistry 
Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology   
Student Code No. 
Protocol for M. Sc. Degree 
In Oral Medicine
 
Academic Year 2021-2022  
Name of Candidate: Reem Kamal Mohamed Abdelaziz 
English title: EVALUATION OF DIODE LASER AND TOPICAL STEROID 
THERAPY IN THE TREATMENT OF EROSIVE ORAL LICHEN PLANUS.  
(A RANDOMIZED CONTROLLED CLINICAL TRIAL)   
 
 
 Keywords: Oral lichen planus, diode laser, topical steroid therapy.   
 
Supervision Committee:  
a. Prof. Dr. Naguiba Mahmoud Elsayed 
     Prof. of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology. 
     Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology.  
     Faculty of Dentistry - Alexandria University. 
b. Prof. Dr. Sabah Abdelhady Mahmoud  
     Professor of Medical Biochemistry. Department of Biochemistry  
     Faculty of medicine - Alexandria University. 
c. Dr. Yasmine Youssri Gaweesh 
Lecturer of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology. 
     Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology. 
     Faculty of Dentistry - Alexandria University 

  
Role of Supervisors 
 
Prof. Dr. Naguiba Mahmoud Elsayed 
 Clinical work supervision. 
 Helping in results interpretation and thesis revision.  
 Follow up all results and verifying them. 
Prof. Dr. Sabah Abdelhady Mahmoud  
 Biochemical measurement and interpretation. 
 Follow up all results and verifying them. 
Dr. Yasmine Youssri Gaweesh 
 Clinical work supervision. 
 Helping in results interpretation and thesis revision.  
 Responsible for patients’ selection. 
 
 
 
 
 
 
 
 
 
 
 
 

  
OUTLINE 
 
Content           
 
 
 
 
 
 
      Page  
 
 ABSTRACT 
1 
 
 INTRODUCTION  
2 
 
 AIM OF THE STUDY 
6 
 FLOW CHART STUDY DESIGN 
7  
 MATERIALS AND METHODS 
8 
 STATISTICAL ANALYSIS 
12 
 ETHICAL CONSIDERATIONS 
13 
 
 DURATION OF STUDY 
14 
 ESTIMATED BUDGET                                                                                           15 
 PROBLEMS ANTICIPATED 
16 
  
 PUBLICATION POLICY 
17 
 
 REFERENCES 
18

  
1 
 
ABSTRACT 
Background: Oral lichen planus (OLP) is a chronic inflammatory 
mucocutaneous disease with uncertain etiology. It may appear as bilateral white 
striations, papules, plaques, erythema, erosions and blisters on the buccal 
mucosa, tongue and gingiva.  
Conventionally, corticosteroid treatments are used as a treatment in Erosive 
OLP. As an alternative method to steroid therapies Diode lasers were 
introduced for the symptomatic relief of pain and burning sensation with no 
adverse effects.  
Study objective: the objective of the study is to compare the effect of topical 
corticosteroid and 980nm Diode Laser in the treatment of erosive OLP. 
Materials and Methods: This study will be conducted on 44 patients 
histologically diagnosed erosive OLP. Patients will be divided into two groups: 
Group I: 22 patients will be given conventional treatment (topical 
corticosteroid), Group II: 22 patients will be treated with 980nm Diode Laser. 
The pain score, clinical and biochemical evaluation will be done at the 
beginning of the treatment, 6 weeks and 12 weeks after treatment. The 
evaluation will be done using Visual Analogue Scale (VAS) for pain 
assessment, the criteria scale described and modified by Thongprasom et al 
2003 for clinical assessment, and oxidative stress biomarker analysis for the 
biochemical evaluation.  
Results: The data obtained will be collected and statistically analyzed. 
Keywords: Oral lichen planus, 980 nm Diode Laser, topical steroid therapy. 

  
2 
 
 

  
3 
 
Introduction 
Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disease, 
which affects the skin, nails, hair and mucous membranes, recognized in 1866. 1 It 
affects 1%–2% of the population at middle age, with a female predominance. OLP 
etiology is unknown but evidence suggests that this disease is an immune-mediated 
process involving cytotoxic T cells as well as the release of a diverse array of 
proinflammatory cytokines that lead to the apoptosis of epithelial cells. 2 
Although the immunological system plays a substantial role in OLP, other 
factors may be also involved, such as psychological stress, drug intake, anxiety and 
some systemic diseases, including hepatitis C virus infection, hypertension, 
diabetes, and graft-vs-host disease. However, the precise role of most of these 
conditions in OLP remains unclear. 3 
Oxidative Stress (OS) may play a central role in the etiology of OLP as the sub 
epithelial infiltration of T lymphocytes in OLP contributes `to the local production 
of cytokines, which can stimulate production of ROS.6 
OS affects the normal intracellular balance, producing excessive oxidant 
substances, i.e., reactive oxygen species (ROS) and reactive nitrogen species 
(RNS) resulting in a relative deficiency of enzymatic and non-enzymatic 
antioxidants as well as oxidation of unsaturated fatty acids in cell 
membranes or lipoproteins inducing lipid peroxidation.7 
Research has demonstrated that increased lipid peroxidation in cell membrane 
can stimulate inflammatory and immune responses. Malondialdehyde (MDA) as 
the most important product of lipid peroxidation can be used as a marker for the 
measurement of oxidative stress. Higher levels of MDA were reported in saliva of 
patients affected by OLP. 8 

  
4 
 
Oxidative stress can be evaluated by the measurement of total antioxidant 
capacity (TAC) in biological fluids. Since the body antioxidants are highly varied, 
use of an index that measures total capacity of antioxidants in biological fluids, 
such as TAC, could be a new and suitable method.8 
As a diagnostic fluid which may be easily collected, saliva is used for the 
measurement of markers of oxidative stress (OS) associated with local oral 
conditions.6 
Clinically, OLP may affect several sites of the oral cavity and several clinical 
manifestations are reported, according to Andreasen classification system: reticular 
(Wickham’s striae), papular, plaque-like “white form”, atrophic (erythematous), 
erosive-ulcerous and bullous-erosive “red form”; however, the classic lesions are 
bilateral, symmetric and composed mainly of a reticular pattern. 4 
It is a challenge to diagnose OLP, particularly in the absence of the classic 
reticular pattern on oral mucosal surfaces. Therefore, an oral biopsy with 
histopathological examination is usually required to confirm the clinical diagnosis 
and exclude dysplasia and cancer. 3, 4, 5 
Symptoms associated with OLP are variable, ranging from no symptoms to 
severe pain. About two-thirds of the patients describe a burning sensation and pain 
in the area of the oral mucosa, which leads to difficulties and restrictions in eating, 
speaking and swallowing. 9 
The asymptomatic forms usually do not need management with drugs; they are 
periodically followed up by clinicians, while the clinical management and 
treatment in symptomatic patients is often required. However, the treatment of 
OLP is not curative, in fact its efficacy is related to the symptoms control and 
ulcers management (especially in erosive OLP). 9,10 

  
5 
 
The conventional treatment of Symptomatic OLP is usually high potency 
topical corticosteroids, systemic prednisone or immunosuppressive agents like 
cyclosporine, tacrolimus and thalidomide. 10,11 However, long-term treatment with 
topical corticosteroids may cause obvious side effects, such as local pigmentation, 
oral candidiasis and dry mouth. Additionally, some studies reported persistent 
lesions with treatment resistance increasing the risk of cancer transformation. 11 
In this context, alternative therapies capable of relieving OLP symptoms with 
minimal or no side effects. Lasers emerge as an option for OLP treatment due to its 
known ability to reduce pain, resolve inflammation and promote tissue repair in 
different pathological conditions. 12 
Different types of lasers with different wavelengths have been utilized in the 
treatment of OLP. ND:YAG, CO2 laser and Low-intensity lasers (LLLT) had a 
remarkable effect on pain, size of lesions and also clinical response.12 
Several LLLT have been used to treat oral lichen planus, but more recently, 
diode (a spectrum of red to infrared wave lengths, 600 to 1100 nm) lasers. These 
lasers have been used with different wave lengths, intensities, powers, durations, 
number of sessions, and therapeutic approaches. 13,14 
 Patients with OLP who were treated by low level laser therapy (LLLT) with 
wavelength of 980 nm reported acceptable results in short follow-up studies, this 
may be due to the effect of LLLT on soft tissues. 15 
Physiologic effects of LLLT on tissues are primary and secondary. Primary 
effects consist of enhancement of blood flow, lymph drainage, cellular 
metabolism, neutrophil and fibroblast activation, and pain stimulation threshold. 
Secondary effects include aggregation of prostaglandins, immunoglobulins and 

  
6 
 
lymphokines, as well as beta-endorphin and encephalin in the tissue, decreasing 
the inflammation, immune response, and pain, respectively. 15 
However, the efficacy of laser in OLP treatment remains uncertain. Some 
studies have shown that conventional therapy with topical corticoids showed better 
control of OLP pain and size when compared to lasers. 14 On the other hand, other 
studies have demonstrated comparable outcomes for patients treated with both 
laser and corticoids. However, these studies used different laser parameters and no 
protocol for laser could be established. 15,16 
These different results of laser therapy may need further investigations to 
resolve the conflict and to assess the effectiveness of LLLT in treatment of OLP. 
The purpose of this study is to evaluate the effectiveness of 980nm Diode 
Laser in the treatment of erosive OLP in relation to conventional corticosteroids. 
The null hypothesis of this research is that there will be no statistically 
significant difference among the test group treated by 980nm Diode Laser and the 
control group treated by conventional therapy. 
 
 
 
 
 
 

  
7 
 
AIM OF THE STUDY 
 The aim of the study is to evaluate the effect of 980nm Diode Laser in the 
treatment of erosive OLP compared with conventional topical corticosteroid 
therapy. 
Primary Objective 
To evaluate clinically on Visual Analogue Scale (VAS) the ability of 980nm 
Diode Laser to control pain compared with topical corticosteroid. 
Secondary Objective 
To test the clinical improvement of OLP according to Thongprasom et al 2003 
scoring system and to evaluate the oxidative stress in saliva biochemically. 
 
 
 
 
 
 
 
 
 
 
 

  
8 
 
FLOW CHART STUDY DESIGN 
 
 
 
 
  
                                                    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Group I = 22 
(Control group) 
Group II=22 
(Study group) 
980nm Diode Laser 
300 mW, 4 J/cm2, 2mm non-
contact mode up to 10 sessions (2 
sessions weekly for 5 weeks) 
 
Conventional treatment 
0.1% topical triamcinolone 
Acetonide preparation 
(Kenacourt-A Orabase 
three times daily for 4 weeks. 
miconazole oral gel once daily 
for 1 week 
The effectiveness of each 
treatment approach will be 
evaluated directly after 6 
and 12 weeks. 
Sample size = 44 
Random Allocation 
Statistical analysis 

  
9 
 
PLAN OF THE STUDY 
Material and Methods 
I. Material 
i. 
Study design and setting: 
This randomized, controlled, clinical trial will be conducted on 44 
patients of both sexes who complain from erosive OLP. They will be selected 
from the outpatient clinic of Department of oral medicine, Faculty of 
dentistry. 
Patients will be given a detailed explanation of the study and will sign 
an informed consent form according to the guidelines of the Ethical 
Committee of the Faculty of Dentistry, Alexandria University. They will be 
treated according to the principles of the modified Helsinki's code for human 
clinical studies (2013). 17 
Inclusion Criteria  
1. Patient histologically diagnosed with erosive OLP based on WHO modified 
criteria 2003. 18 
2. Patients 30-70 years of age.  
3. Presence of painful erosive OLP lesions diagnosed by biopsy. 18 
Exclusion Criteria  
1. Pregnant or breast-feeding women. 18 
2. Patients currently treated for cancer with Chemotherapy or Radiotherapy. 15 
3. Patient currently on Corticosteroid therapy or had been on treatment on the 
past 3 months. 18 

  
10 
 
4. Those who had used Anti-inflammatory drugs topical or systemic in the last 
month. 2 
5. Those who reported use of drugs related to Oral Lichenoid Lesions. 2 
6. Presence of Amalgam restorations near the OLP lesions. 20 
7. Those with description of dysplasia in histopathological examination. 20 
8. Patients suffering from any uncontrolled systemic diseases (such as diabetes, 
cardiovascular, liver disorder, renal dysfunction) 20 
9. Patients with findings of any physical or mental abnormality which would 
interfere with or be affected by the study procedure. 2 
10. Patients with skin lesion. 
ii. 
Sample size calculation:  
Sample size will be estimated assuming confidence level = 95% and study 
power = 80%. The mean (SD) reported pain scores measured by the 
Visual Analogue Scale after 3 months for the laser group was 0.79 (1.23) 
and for the steroid group was 2.81 (2.84). The minimum sample size was 
calculated to be 20 patients, increased to 22 patients per group to make up 
for possible loss to follow up. 
The total sample size = number of groups × number per group= 2 X 22= 
44 patients. 
Sample size was based on Rosner’s method calculated by G power 3.0.10. 
21, 22, 26 
II. Methods 
Randomized Controlled Clinical Study 
 
The purpose and nature of the study will be explained for the selected 44 
patients and an informed consent will be obtained from patients who agree to 
participate in this study prior to any procedure. 

  
11 
 
An incisional biopsy will be performed under local anesthesia from the lesion to 
exclude dysplasia and cancer. 
Grouping and Randomization 
The selected patients will be randomly assigned to the following groups: 
Group I (Control group) 
22 patients will be given topical corticosteroid 0.1% topical triamcinolone 
acetonide preparation (0.1% triamcinolone acetonide orabase, Kenacort-A Orabase 
Pomad, DEVA HOLDING A.Ș, Istanbul, Turkey) three times daily for 4 weeks. 
The application should be in one direction with no food or fluid after 
administration for a minimum of 1 hour post application. Also, patient will be 
applying miconazol oral gel once daily to avoid superimposed fungal infection. 20 
 
Group II (Study group)  
22 patients will be subjected to laser therapy by the 980 nm diode laser ( 
MEDENCY ,PRIMO – Vicenza Italy) for photobiomodulation (PBM) and the 
treatment will be continued up to 10 sessions (2 sessions per week).  
A Fiber Tip with a diameter of 400µm will be used. The output power will 
be 300 mW and the average power density about 1 W/cm2. A “spot” technique will 
be used, with a slight overlapping in order to evenly distribute energy covering all 
the mucosal lesions and also the peri-lesional tissues up to 0.5 cm. 
Each session will be performed delivering a fluence of 4 J/cm2 per lesion, 
and the probe will be held perpendicularly at a distance of about 2 mm. The time of 
delivery per point of application is approximately 4 Sec in continuous wave with 2 
sessions weekly. After each laser session, a cold diet will be recommended. 20,22 
 
 
 

  
12 
 
Allocation concealment  
Allocation of cases will be via block randomization method using a 
computer generated random sequence into 2 groups of equal numbers (N=22 
patient/ group).27 
Allocation will be informed by a trial independent individual. The 
participant allocation will be kept in opaque, sealed envelopes and arranged 
sequentially by a dental assistant, who will not be involved in the study. 
Each envelop will be opened after completing the oral examination and right 
before the application of the intervention.  
A) After biopsy and before treatment: 
  
1. Detailed medical and dental history will be obtained from the selected patients.  
2. Thorough intraoral examination will be performed to determine the need for 
scaling and treatment of any source of irritation.  
3. Oral hygiene instructions will be carried out to all patients.  
4. Adequate hydration will be advised.  
5. Every group of patients will be given their treatment protocol. 
 
B) During and after treatment:  
 
Clinical Evaluation:  
All patients will be clinically and biochemically evaluated before treatment, after 6 
and 12 weeks with following criteria:  
 
1- Subjective assessment  
Discomfort and pain severity will be reported by each patient using Visual 
Analogue Scale (VAS). The VAS consisted of a 10-cm horizontal line marked 0 (= 

  
13 
 
no pain) to 10 (= most severe pain ever experienced). Patients will be requested to 
mark the scale at each visit, before and after treatment for each group . Complete 
resolution of the symptoms (no symptoms) will be defined as the absence of any 
discomfort, corresponding to a zero VAS score. 
The stability of the results in the follow-up period will be also described. 20, 22 
2- Objective assessment  
 The size of the lesion and the healing pattern will be monitored. The clinical 
data will be scored according Thongprasom et al 2003 scoring system. Score 
5: white striae with erosive area >1 cm2, Score 4: white striae with erosive 
area <1 cm2, Score 3: white striae with erythematous area >1 cm2, Score 
2: white striae with erythematous area <1 cm2, Score 1: mild white striae 
only, Score 0: no lesions, normal mucosa. 2,24 
 Measurement of Total Oxidative Stress in saliva including Total antioxidant 
capacity (TAC) and malondialdehyde (MDA). Saliva will be collected 
before treatment and after 6 and 12 weeks. Saliva will be collected, 
centrifuged at 30 g for 10 min to evacuate cellular debris and microscopic 
organisms. The filtered saliva will be stored at −80°C until the time of the 
biochemical investigation (Tvarijonaviciute, Aznar-Cayuela, Rubio, Ceron, 
& López-Jornet, 2017). The determination will be measured using the 
established colorimetric method (Koracevic, Koracevic, Djordjevic, 
Andrejevic, & Cosic, 2001). Biochemical analysis will be conducted at the 
Department of Biochemistry, Faculty of Medicine, Alexandria University.25 
3- Photographs:  
Photographs will be taken at baseline and at the end of the study. 
 
 
 
 

  
14 
 
STATISTICAL ANALYSIS 
 
The data will be processed and analysed using Statistical Package for 
Social Sciences program SPSS software*.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                          
* Armonk, NY: IBM Corp, USA. 

  
15 
 
ETHICAL CONSIDERATIONS 
The clinical part of the study will be performed after the approval of the Research 
Ethics Committee, Faculty of Dentistry, Alexandria University. 
The volunteers will provide written informed consent and the study will be 
conducted in accordance with the modified Helsinki Declaration of 2013.14 
The patients will receive written consent about the study protocol before agreeing 
to participate in the study. The patients will have the right to withdraw at any time 
during the study. 
Clinical trials need written informed consent in order to clarify objectives, risks 
and benefits of the study. 
Medical therapy for potential risks will be provided (cortico steroids will be 
administered in case of severe pain after laser treatment ).  
 
 

  
16 
 
DURATION OF THE STUDY 
Estimated time: Twelve Months. 
Months 
 
        Study 
activities 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Purchase 
of 
materials 
 
 
 
 
 
 
 
 
 
 
 
 
Patient selection and 
Clinical study 
 
 
 
 
 
 
 
 
 
 
 
 
Data 
management 
and 
statistical 
analysis 
 
 
 
 
 
 
 
 
 
 
 
 
Writing thesis 
 
 
 
 
 
 
 
 
 
 
 
 
Thesis submission 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
17 
 
ESTIMATED BUDGET  
Item 
Cost in LE 
Laser equipments 
10000 
Medications  
2000 
Statistical analysis 
3000 
Thesis printing and Binding 
5000 
Publication  cost 
2000 
Total 
22,000 
 
 
 

  
18 
 
PROBLEMS ANTICIPATED 
 
 Availability of patients with satisfactory oral hygiene and not medically 
compromised. 
 Difficulty in convincing the patients to participate in the study. 
 Cooperation of the patients and compliance to treatment . 
 High cost of the proposed interventions .  
 
 
 
 
 
 
 
 
 
 

  
19 
 
 
PUBLICATION POLICY 
This study will be sent for either national or international Journal for 
publication, in the following order: 
- Reem kamal Mohamed Abd elaziz 
- Prof. Dr. Naguiba Mahmoud Elsayed. 
- Prof. Dr. Sabah Abdelhady Mahmoud . 
- Dr Yasmine Yousri Gawish . 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
20 
 
 
 
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