|Year : 2022 | Volume
| Issue : 1 | Page : 11-16
Evaluation of efficacy of three treatment modalities in the management of symptomatic oral lichen planus—A Prospective comparative study
CJ Sanjay, Karthikeya Patil, Mahima V Guledgud, Prasannasrinivas Deshpande, Nagabhushana Doggalli, Romali Panda
Department of Oral Medicine and Radiology, JSS Dental College and Hospital, JSS Academy of Higher Education and Research (JSSAHER), Mysuru, Karnataka, India
|Date of Submission||17-Jun-2021|
|Date of Decision||05-Jan-2022|
|Date of Acceptance||13-Jan-2022|
|Date of Web Publication||25-Mar-2022|
Dr. Karthikeya Patil
Professor and HOD, Department of Oral Medicine and Radiology, JSS Dental College and Hospital, JSS Academy of Higher Education and Research, Mysore - 570 015, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Context: Oral lichen planus (OLP) is a relatively common chronic inflammatory condition of the oral mucosa. OLP is currently managed by various treatment protocols, the most common being topical and systemic corticosteroid therapy. Low-level laser therapy (LLLT), or photo-biomodulation, is gaining popularity as a palliative treatment for OLP. Aim: The present study was aimed to compare the efficacy of LLLT, topical corticosteroid therapy, or a combination of both in the management of OLP. Settings and Design: Thirty patients who were clinically and histopathologically diagnosed as OLP were randomly selected and divided into three groups: Group 1 (n = 10) received topical corticosteroid therapy (TCT); Group 2 (n = 10) received LLLT; and Group 3 (n = 10) received combination of both the therapies. Materials and Method: Each group of patients received treatment in five sessions of their respective therapy over the course of 15 days, with a three-day interval between each follow-up. The VAS (visual analogue scale) was used to collect data on pain. The percentage of healing was calculated using the WHO oral mucositis assessment scale, the global healing index, and the WU et al. (2010) disease grading system. Results: A reduction in scores in VAS, WHO oral mucositis assessment scale, global healing index, and WU et al. (2010) disease scoring system with the combination of LLLT and topical corticosteroid therapy was observed. Conclusion: Both LLLT and TCT were effective against the symptom control and improvement in clinical manifestation of oral lichen planus, nevertheless; a combination of the two was found to be more beneficial in treatment of symptomatic OLP.
Keywords: LLLT (low-level laser therapy), oral lichen planus, photo-biomodulation, topical corticosteroid therapy
|How to cite this article:|
Sanjay C J, Patil K, Guledgud MV, Deshpande P, Doggalli N, Panda R. Evaluation of efficacy of three treatment modalities in the management of symptomatic oral lichen planus—A Prospective comparative study. J Indian Acad Oral Med Radiol 2022;34:11-6
|How to cite this URL:|
Sanjay C J, Patil K, Guledgud MV, Deshpande P, Doggalli N, Panda R. Evaluation of efficacy of three treatment modalities in the management of symptomatic oral lichen planus—A Prospective comparative study. J Indian Acad Oral Med Radiol [serial online] 2022 [cited 2022 May 27];34:11-6. Available from: https://www.jiaomr.in/text.asp?2022/34/1/11/340731
| Introduction|| |
Lichen planus is a chronic inflammatory disease that affects skin and mucous membrane. The skin lesions present as violaceous flat-topped papules in ankles, wrist, and genitalia, but characteristically the facial skin is spared. Oral lichen planus (OLP) may present alone or with concomitant skin lesions. OLP affects women over men, especially the fourth decade of life with a predilection of 1.4:1. This disease affects almost 1–2% of the population globally.
OLP presents clinically in various forms, of which reticular remains the most common. Intraorally, buccal mucosa, tongue, and gingiva are commonly involved sites, while other sites may be seldom affected. The disease etiology still remains obscure, but there are numerous predisposing factors like anxiety, stress, diabetes mellitus, hypertension, metabolic syndrome, thyroid diseases, psychosomatic ailments, chronic liver disease, gastrointestinal diseases, and genetic susceptibility to cancer. OLP is a T-cell-mediated autoimmune disease, wherein the auto-cytotoxic CD8+ cells cause apoptosis of the basal cells of the epithelium.
A recent meta-analysis stated that 1.1% of OLP lesions developed into oral squamous cell carcinoma (OSCC) with a better prevalence in smokers, alcoholics, and those infected with hepatitis C virus. Muñoz et al. have located that, at the average, it takes 5.5 years for OLP lesions to convert into a longtime OSCC.
The possible impacts of LLLT on OLP signs (clinical appearance) and symptoms (pain) might be attributed to a variety of processes. LLLT aids in the creation of ß-endorphins and enkephalins, as well as the lowering of bradykinin and histamine levels, resulting in an analgesic effect and pain alleviation. The analgesic effect of LLLT is also supported by its influence on the C fibers, which reduces their activity and so reduces pain stimuli conductance.
LLLT has a number of advantages over other traditional techniques, such as corticosteroids, including its safety and lack of side effects. One of the corticosteroid-using studies included in the study showed significant side effects such as burning and gastrointestinal distress. The chronic nature of OLP needs long-term administration of corticosteroids, which have a number of side effects including mucosal atrophy, secondary candidiasis, and adrenal insufficiency, and hence their usage in hypertensive and diabetic patients is restricted., As a result, LLLT can be regarded a potential option in these patients.
Although largely palliative, a variety of therapeutic techniques, such as topical therapy and laser therapy, are used. Over the years, topical corticosteroid therapy (TCT) has been the most common treatment for OLP, while low-level laser therapy (LLLT) is a more recent development. ,
| Methodology|| |
The aim and objective of the study was to compare different management modalities in oral lichen planus on the basis of pain and percentage of healing using VAS, WHO oral mucositis assessment scale, and global healing index, respectively.
An approval by the Institutional Ethical Committee of JSS Dental College and Hospital (No.: JSS/DCH/Ethical/RP-03/2013-14, Dated 06/02/2014) was obtained before the conduct of the study. A written informed consent was taken from all the patients, and data were kept undisclosed according to the principles of the Helsinki Declaration; the patients were aged between 18 and 60 years. A sample size of 30 subjects was calculated by using a formula with a known lichen planus disease prevalence of 2.6% in India. All subjects were included by a purposive sampling method, and single-blind distribution method was followed.
The study population was selected from the outpatient section from the Department of Oral Medicine and Radiology. The inclusion criteria were clinically and histopathologically diagnosed cases of oral lichen planus. Modified WHO diagnostic criteria of OLP were used (2003). Patients who had lesions with dysplasia or had received treatment for OLP at least 1 month before the beginning of the study, patients with lichenoid lesions, and patients with any contraindications for undergoing LLLT were excluded from the study. Patients who develop any adverse reactions to TCT and/or LLLT during the study and patients unwilling to continue their participation in the study at any stage after signing the written consent were withdrawn from the study. A specially designed study pro forma was used to record relevant data.
Study subjects were randomly divided into three groups of ten patients each with no gender barrier. Group 1 patients (n = 10) received TCT alone; Group 2 patients (n = 10) received LLLT alone; and Group 3 patients (n = 10) received a combination of both the therapies.
For Group 1 patients, the following TCT was employed: The patients were requested to disperse betamethasone valerate 0.5 mg—1 Tab in 10 ml of water—and use the solution as mouthwash TDS for a week. This was followed by topical application of triamcinolone acetonide oral paste (0.1%) over the lesions. The patients were advised to refrain from eating/drinking for an hour after the application.
For Group 2 patients, LLLT was performed using gallium arsenide (GaAs) [Prometheus-M] laser with an emission wavelength of 904 nm. The pain-causing trigger points were located using the erythema gradient and clinical presentation as well as patient history. Laser therapy was executed through light, still and direct contact of the probe, placed perpendicularly on the lesion. Each patient in Groups 2 and 3 was irradiated once in 3 days for five sessions for 2 min at a frequency of 4000 Hz with 10 cycles with point to point in the papule or as a point-to-point contact in the lesion, which was adopted as per the manufacturer's recommendations. As the type of laser employed belonged to Class 3B, both the patient and the operator were protected using the protective eyewear during the entire therapeutic session.
For Group 3 patients, both TCT and LLLT were employed as outlined above.
All the patients were treated with their respective treatment modality for five sessions with a follow-up every 3 days.
Assessment of pain and healing was performed at baseline and immediately after each session using visual analogue scale (VAS), WHO oral mucositis assessment scale, and global healing index. Relevant data were recorded in a specially designed pro forma for each group of patients, which mentioned about the personal data, details of the lesion, namely site, size, type of the lesion, and any other medications taken previously for the management of lichen planus. The data obtained were tabulated and subjected to statistical analyses using SPSS for Windows version 20.0
| Results|| |
From [Table 1], it was clear that Group 3 patients had a maximum reduction in pain (mean decrease = 4.5 scores) followed by Group 2 patients (mean decrease = 2.4 scores) and Group 1 patients had the least decrease in the pain scores (mean decrease = 1.8 scores) [[Table 1]: Group of patients along with mean VAS scores and standard deviation which is from baseline visit followed by the fifth visit] [[Figure 1]a baseline visit and [Figure 1]b final visit for Group 1 wherein topical corticosteroid therapy was employed]. [[Figure 2]a baseline visit and [Figure 2]b final visit for Group 2 wherein only LLLT was employed]
|Table 1: Group of patients along with mean VAS scores and standard deviation which is from baseline visit followed by the fifth visit|
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|Figure 1: Showing Group 1 patients (a)at baseline visit and (b) at final visit where in topical corticosteroid therapy was employed|
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|Figure 2: Showing Group 2 patients (a)at baseline visit and (b) at final visit where in LLLT therapy was employed|
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Descriptive statistics include a table of mean VAS scores of different groups on various visits of three groups and results of repeated measures ANOVA mean and standard deviation.
A significant gradual increase was observed in Group 3 patients in terms of a decrease in VAS scores and percentage of healing from baseline visit to final visit [[Figure 3]a baseline visit and 3b final visit, respectively, for Group 3 where a combination of LLLT and topical corticosteroid therapy was employed].
|Figure 3: Showing Group 3 patients (a) at baseline visit and (b) at final visit where in a combination of LLLT and topical corticosteroid therapy was employed|
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[Graph 1] shows a significant decrease in VAS scores from visit 1 to visit 5 (F = 165.83; P = 0.01), where a decrease of 2.9 scores (V1 = 7.83 to V5 = 4.93) from visit 1 to visit 5 was observed. Further, when a group-wise decrease was analyzed, RM ANOVA (repeated measures ANOVA) revealed a significant value (F = 13.03; P = 0.01).
[Graph 2] shows a significant increase in the mean percentage of healing from visit 1 to visit 5 irrespective of the groups (F = 154.386; P = 0.001) [[Table 2]: Group of patients along with mean healing percentage and standard deviation which is from baseline visit followed by the fifth visit]. An increase of 29.33% observed from visit 1 to visit 5 was found to be highly significant. Further, when group-wise analysis was made for an increase in healing percentage, a significant F value is observed (F = 13.458; P = 0.001). From the [Table 2], it is clear that the healing percentage was significantly higher in Group 3 (45%) than Groups 2 and 1 (23% and 17%, respectively).
|Table 2: Group of patients along with mean healing percentage and standard deviation which is from baseline visit followed by the fifth visit|
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| Discussion|| |
Lichen planus is a persistent inflammatory disorder of the mucous membranes and skin caused by an immunological response. OLP is usually asymptomatic, although it can manifest as erosion or ulceration, and the patient may experience varying degrees of discomfort, especially when eating spicy or acidic foods.
The following are the modified WHO diagnostic criteria for OLP and OLL (2003).
Criteria for clinical evaluation:
- Bilateral, more or less symmetrical lesions are seen.
- A lacelike network of slightly elevated gray-white lines is present (reticular pattern).
- In the presence of reticular lesions elsewhere in the oral mucosa, erosive, atrophic, bullous, and plaque-type lesions are only recognized as a subtype.
Criteria for histopathological confirmation:
- A well-defined band-like zone of cellular infiltration localized to the superficial section of the connective tissue, primarily composed of lymphocytes, is present histopathologically.
- The absence of epithelial dysplasia.
- Signs of liquefaction degeneration in the basal cell layer.
The term “histopathologically compatible with” should be used when the histopathologic traits are less clear. Both clinical and histopathologic criteria must be met to get a final diagnosis for OLP or OLL.
The term OLL (oral lichenoid lesions) will be used in the following situations:
- Clinically similar to OLP but histopathologically only compatible with OLP.
- Histopathologically only compatible with OLP but clinically only compatible with OLP.
- Clinically and histopathologically compatible with OLP.
Although OLP can regress on its own, many lesions require treatment at some point. Corticosteroid therapy has proven to be the most effective treatment because reduced exudation of leukocytes and plasma constituents, maintenance of cellular membrane integrity, inhibition of lysosome release from granulocytes, inhibition of phagocytosis, preservation of the membranes of intracellular lysozymes, and inhibition of fibroblast proliferation are all mechanisms by which the corticosteroid acts as an anti-inflammatory. Routes of administration of corticosteroid range from topical, systemic to intra-lesional.
Williams et al. (1964) discovered that cutaneous lesions of lichen planus regressed efficaciously when betamethasone 17-valerate was given, a synthetic corticosteroid with a stronger anti-inflammatory action than cortisone. Cawson et al. claimed that when 0.1 mg of pellets was dissolved in water, betamethasone 17-valerate might reverse the chronic lesions of oral lichen planus. Triamcinolone acetonide (0.1%) is a moderately potent corticosteroid commonly used and found to be most efficacious in the management of erosive and ulcerative OLP.
Low-level laser therapy or photo-biomodulation is a contemporary treatment modality with minimal side effects.,, Low-level lasers have primary or secondary physiological effects on tissues. Vasodilation, improved blood flow, lymph drainage, cellular metabolism, neutrophil and fibroblast activation, and pain stimulation sensitivity are the primary consequences. Inflammation, immunological reaction, and pain are all decreased as a result of the aggregation of prostaglandins (such as prostaglandin E2), immunoglobulins, and lymphokines, whereas beta-endorphin and enkephalin in the tissue are the secondary effects. OLP has been treated using a range of low lasers, including ultraviolet (wavelengths below 350 nm), helium–neon (632 nm), and, more recently, diode lasers (a spectrum of red to infrared wavelengths, 600 to 1100 nm). Different wavelengths, intensities, powers, durations, number of sessions, and treatment procedures have all been employed with these lasers.
LLLT in the present study was delivered using gallium arsenide (GaAs) [Prometheus-M] laser with an emission wavelength of 904 nm. The pain-causing trigger points were located using the erythema gradient and clinical presentation as well as patient history. Laser therapy was executed through light, still and direct contact of the probe, placed perpendicularly on the buccal mucosa. Each patient in Group 2 and 3 was irradiated for 2 min at a frequency of 4000 Hz with 10 cycles as per the manufacturer's recommendations. As the type of laser employed belonged to Class 3B, both the patient and the operator were protected by protective eyewear during the entire therapeutic session.
Group 1 patients received TCT, Group 2 patients received LLLT, and Group 3 patients received both the above therapies.
Assessment of pain was performed at baseline and immediately after each session using visual analogue scale (VAS) and was repeated at every follow-up session for five visits. Pain intensity was scored using a visual analogue scale (VAS) of 0–10 (with 1 mm division, where “0” is no pain and “10” is the worst possible pain).
At the baseline visit, the healing and clinical presentation of the lesion, as well as inflammatory changes, were assessed based on clinician judgment and using the WHO oral mucositis assessment scale by WHO handbook 1979, the global healing index by Lemo et al., and Wu et al. (2010) disease scoring system (Adapted from Athar and Gentile 2009).
- Soreness with or without erythema (Grade 1).
- Erythema, ulcers, and the ability to swallow solid food (Grade 2) symptoms.
- Ulcers with a lot of erythema and the patient cannot swallow (Grade 3).
- Mucositis to the point that eating is impossible (Grade 4).
Lemo et al. provided the global healing index (GHI), given by the formula GHI = SCI + DCI – WCI [superficial contraction index (SCI); deep contraction index (DCI); wound contraction index (WCI)]. This index allows scoring of the healing process and follow-up of its progress.
Wu et al. (2010) gave the morphological findings: size of erosive area, recurrence rate, adverse effects of treatment, and VAS for pain analysis.
Results of this study indicated that a combination of LLLT and TCT was remarkably effective in alleviation of signs and symptoms of OLP. The percentage of healing in Group 3 patients was found to have a significant increase from baseline visit to the fifth visit followed by Group 2 and then Group 1 patients. This improvement could be attributed to a cumulative effect over the five therapeutic sessions, as immediate effect after each session was not noteworthy. A steadily rising improvement in symptoms and pain depletion and percentage of healing was noted between sessions for patients of Group 3.
The regression happened for a time duration of 15 days gradually in all the groups. Group 3 patients showed the most significant decrease in the VAS and in the clinical presentation. This study is in consistent with Jajarm et al. wherein they concluded that the LLLT could be used as effectively as topical corticosteroid therapy and could be used as a possible substitute in the coming years. Their study also showed that LLLT could be used as a management modality of erosive/ulcerative OLP.
The current study also corroborates with Mahdavi O. et al. wherein they found out that low-level laser therapy could be used as a replacement in the management of atrophic/erosive OLP; their study also depicted that a significant decrease happens in the disease process as a cumulative effect of various irradiations with LLLT.
| Limitations, Future Considerations, and Conclusions|| |
It could be altercated that the magnitude of LLLT in alleviating clinical signs and symptoms of OLP is still contentious compared to steroid therapy. Despite the limited sample size, it appears that 904 nm LLLT was much more effective and better than the topical corticosteroid therapy in the treatment of OLP and even exhibited greater results in long-term follow-up. Furthermore, LLLT had no unfavorable side effects. More extensive randomized controlled trials are needed based on these findings to better establish the conclusions of our current study. Also, in future research should include a comparison of the effectiveness of diode lasers with other noninvasive techniques.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]