|Year : 2021 | Volume
| Issue : 3 | Page : 286-293
Comparison of efficacy of combination therapy (Low Level Laser Therapy (LLLT) and topical steroid) with topical steroid therapy only in patients with symptomatic oral lichen planus – In vivo study
Richa Jain1, Amit Anil Mhapuskar1, Darshan R Prasad Hiremutt1, Isha Kale1, Kedarnath Kalyanpur2, Harshit Bhadani1
1 Department of Oral Medicine and Radiology, Bharati Vidyapeeth, Dental College and Hospital, Pune, Maharashtra, India
2 Department of Oral Medicine and Radiology, Singhad Dental College, Pune, Maharashtra, India
|Date of Submission||06-May-2021|
|Date of Decision||17-Aug-2021|
|Date of Acceptance||25-Aug-2021|
|Date of Web Publication||28-Sep-2021|
Dr. Richa Jain
Department of Oral Medicine and Radiology, Bharati Vidyapeeth, Dental College and Hospital, Pune, Maharashtra
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Aim: To compare the efficacy of combination therapy (low level laser therapy [LLLT] and topical steroids) with topical steroid therapy alone in individuals with symptomatic oral lichen planus. Materials and Methods: The study was conducted on 30 patients who reported to our department with clinically and histologically proven symptomatic oral lichen planus (OLP). All the patients were assessed for the criteria of outcome—pain, burning sensation, size of the lesion, clinical resolution, and recurrence. The patients were randomly assigned into two groups each comprising of 15 patients. Group I (study group) patients received a combination of topical steroid and LLLT while Group II (control group) patients received only topical steroid therapy. Results: A significant pain and burning sensation reduction were found in the patients who were given LLLT (P: 0.05). There was a decrease in the size of the lesion which was statistically significant. A complete clinical resolution was achieved and only 11% recurrence occurred in the study group. This therapy appears to be effective in patients with symptomatic OLP. Conclusion: The LLLT therapy appears to be useful in relieving pain and burning sensation, reduction in the size of the lesion, with complete clinical resolution and minimal recurrence, and hence, can be considered as a valuable aid in managing symptomatic OLP. Thus, the LLLT therapy serves as a potent and independent therapeutic modality in symptomatic OLP.
Keywords: Combination therapy, low-level laser therapy, oral lichen planus, topical steroid
|How to cite this article:|
Jain R, Mhapuskar AA, Prasad Hiremutt DR, Kale I, Kalyanpur K, Bhadani H. Comparison of efficacy of combination therapy (Low Level Laser Therapy (LLLT) and topical steroid) with topical steroid therapy only in patients with symptomatic oral lichen planus – In vivo study. J Indian Acad Oral Med Radiol 2021;33:286-93
|How to cite this URL:|
Jain R, Mhapuskar AA, Prasad Hiremutt DR, Kale I, Kalyanpur K, Bhadani H. Comparison of efficacy of combination therapy (Low Level Laser Therapy (LLLT) and topical steroid) with topical steroid therapy only in patients with symptomatic oral lichen planus – In vivo study. J Indian Acad Oral Med Radiol [serial online] 2021 [cited 2021 Nov 29];33:286-93. Available from: https://www.jiaomr.in/text.asp?2021/33/3/286/326892
| Introduction|| |
Oral lichen planus (OLP) is a chronic, mucocutaneous disease of unknown origin. It may also occur concurrently or independently and affects the skin and oral mucosa. The most typical oral site for OLP is the buccal mucosa, but any other oral mucosal site can also be affected including labial mucosa, tongue, and gingiva. Globally, the prevalence of OLP has been reported to be 1.27% in the general adult population. In the Indian population, it is 1.5% and is more frequently seen in women aged between 30 and 60 years.,
A large spectrum of treatment modalities including topical and systemic corticosteroids, topical cyclosporine, topical and systemic retinoids, antimalarials, azathioprine, photochemotherapy, and surgery have been proposed for symptomatic OLP. Patients with symptomatic OLP often require intensive therapy to lessen the signs and symptoms. Therefore, the search for a new treatment modality capable of controlling the symptoms and signs of OLP with minimal side effects remains an important challenge.
Low level lasers therapy (LLLT) has come up recently as a new treatment modality for OLP without having significant adverse effects., This treatment modality is painless, well-tolerated by its non-invasive nature, and has achieved significant clinical improvement in most patients. It has been found that LLLT has bio stimulating effects on the oral mucosa. It also improves tissue healing by controlling inflammation.
Hence, this study was planned to compare the efficacy of the combination therapy (LLLT plus topical steroid) with standard topical steroid therapy alone in managing the patients with symptomatic OLP with a long-term follow-up.
| Aim|| |
To compare the efficacy of the combination therapy using LLLT along with topical steroids and with topical steroid therapy alone in individuals with symptomatic OLP.
| Objective|| |
- To determine the effectiveness of the combination therapy for OLP.
- To determine the effectiveness of topical steroids therapy alone for OLP patients.
- To compare the effectiveness of the combination therapy with topical steroids therapy alone for OLP patients.
| Methodology|| |
This randomized single-blind study was carried out at the Department of Oral Medicine and Radiology of a dental college in Pune, Maharashtra, and was approved by the Institutional Ethical and Scientific Committee Board (ECR/328/Inst/MH/2016) and with the Helsinki Declaration of 1975 that was revised in 2000. Informed written consent was obtained from all the willing participants.
This is a single-blinded, randomized, parallel comparison, follow-up study. The sample size was estimated to be 15 per group by considering a level of significance as 5%, power of study as 80%, level of precision (L) as 0.3, standard deviation as 0.37, n = (Z1-α- Zβ) σ2 / L2, level of significance as 5%, power of study = 80%, level of precision (L) =0.3, and standard deviation = 0.37. The study consisted of 30 patients who came to the Department of Oral Medicine and Radiology within the age group of 18–60 years of either gender. Those patients with clinically and histopathologically proven OLP were selected for the study.
Inclusion and exclusion criteria
- Patients, 18 years and above, with clinically and histopathologically proven symptomatic OLP
- Patients voluntarily willing to be a part of the study after signing the informed consent
- Patients with OLP lesion on multiple sites
- Pregnant or breastfeeding women
- Patients using any drugs which may induce lichenoid reaction and also patients on steroid therapy for any other reason
- Patients with the presence of dysplasia in their biopsy specimen
- Patients who have received therapy for OLP within 1 month before the start of the study
- Patients with any systemic diseases and any lesions adjacent to amalgam/metallic restoration
Randomization: Thirty patients were selected in our study and were numbered serially as they became the participants in the study. Based on the two series, the participants got assigned either to the study group (Group A) or control group (Group B)
Concealment of Allocation and Single Blinding: The principal investigator carried out the initial as well as periodic evaluations of all the participants. To minimize bias, the investigator was unaware of the group to which the participants belonged, either to the study group or control group.
The interventions (LLLT) were carried out by another investigator who was blinded to the signs and symptoms of the patient as well as to the data gathered in case proforma by the principal investigator.
After obtaining the informed consent, data were recorded in the predesigned case proforma. These were the criteria for the assessment of the outcome: pain, burning sensation, size of the lesion, clinical resolution, and recurrence were noted down in the predesigned case proforma. In both groups, pain and burning sensation were evaluated using the visual analog scale (VAS). These patients were evaluated for the size of the lesion with the help of the digital Vernier Caliper according to the area of involvement and were scored according to the criteria given by Piboonniyom SO et al.: 0 = lesion is absent, 1 = lesion is present, and the size of the lesion <1 cm2, 2 = lesion is present and the size of the lesion is from 1 to 3 cm2, 3 = lesion is present and lesion >3 cm2. A complete clinical resolution of the lesion is defined as the total disappearance of the lesion from the primary site and was scored according to the criteria given by Piboonniyom SO et al. Those patients who achieved the complete clinical resolution of the lesions during the active phase of the study were advised to stop the therapy and further follow-up was there for 2 months for any recurrence (once every 15 days) and the recurrence was also evaluated. It was defined as the return of the signs and symptoms at the same site after complete remission; if the recurrence was present, it was recorded in proforma.
Interventions of both groups
Both the groups (Groups A and B) were treated by topical steroid therapy that includes topical 0.1% triamcinolone acetonide oral base (Kenacort TM 0.1% Abbott, India) (apply five times on the affected area for 28 days/till the lesion heals; whichever is earlier)
In the study group, in addition to the conventional therapy, LLLT was also given to the patients. The LLLT was delivered by the photon (3W) zolar diode laser with the following specifications: wavelength: 810 nm, mode: continuous defocused non-contact mode, power output: 0.8–0.9 W, time duration: 10 min laser equipment (photon: 3W diode laser with bio stimulating handpiece (600 um fiberoptic cable) with activator, cutter, and protective eyewear and armamentarium for the application of triamcinolone acetonide 0.1% during the LLLT procedure) [Figure 1]. The device was used according to the manufacturer's instructions. The laser was guided with a bio stimulating handpiece connected to a 400 μm fiberoptic cable. A 'spot' technique was used with slight overlapping to evenly distribute energy over the entire surface of the lesion. The spot denotes the size of the tip of the laser probe (spot size). All the protective laser protocols were followed, i.e., the patient and all the assistants (auxiliaries) were advised to wear special protective eyeglasses before the laser therapy. The LLLT was started from day 0 with the above-mentioned specifications. The therapy was done twice a week lasting for nine sessions.
|Figure 1: Laser equipment (photon: 3 W diode laser with biostimulating handpiece [600 um fiberoptic cable] with activator, cutter, and protective eyewear and armamentarium for the application of triamcinolone acetonide 0.1% during the LLLT procedure|
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After the patient got to sit comfortably on the chair, the lesion was wiped with sterile cotton gauze to remove any salivary contamination. Then, with the help of a cotton applicator tip, a pea-size gel, i.e. 0.1% triamcinolone acetonide in the ora base (Kenacort TM0.1% Abbott, India) was gently applied over the area of the lesion. This gel acts as a surface barrier for the biostimulation of the laser. The active phase of the study ended after 28 days.
Following the active phase, the patients were again recalled during the follow-up phase on days 45, 60, 75, and 90, and all the clinical parameters were recorded. Data gathered at each of the active and follow-up phases were entered in the case proforma. The photographic records of the lesions were obtained at the baseline as well as the periodic visits.
Data analysis and statistics
The entire data was collected, coded, and entered in Microsoft Excel 2013. The Statistical Package for Social Software (SPSS) 22.0; IBM Analytics, NY, USA, was used to carry out the statistical analysis. All the P values less than 0.05 were considered to be statistically significant. The results were presented in the form of tables and relevant graphs.
| Results|| |
The present study consisted of 30 patients; 15 patients in each group, among them 20 were females and 10 were males and were diagnosed with symptomatic OLP (ratio F: M =2:1) ([Figure 2a]—gender distribution in both the groups). The number of subjects within the age range of 18–30 years was 8 (24%) and above 30 years was 22 (76%) ([Figure 2b]—demographic distribution in both the groups). The symptomatic OLP patients were distributed mainly into two types of lesions. Out of 30 patients, 18 were non-erosive whereas 12 were erosive ([Figure 2c]—distribution of the type of lesions).
|Figure 2: 2a: Gender distribution in both the group, 2b: Demographic distribution in both the groups, 2c: Distribution of type of the lesions|
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The outcomes assessed were a change in the pain score, a change in the burning sensation score, a change in the size of the lesion, complete clinical resolution of the lesion. Recurrence, if any, was compared between the groups: study group (Group A) and control group (Group B).
[Table 1]: Comparison of pain scores in both groups [Figure 3]
At the start of the study, the pain score in both the groups was almost similar (8.46 mm in the study group and 8.53 mm in the control group) and the difference was not found to be statistically significant. The overall reduction in the pain score was significantly more in the study group (8.46 –1.13 mm) as compared to the control group (8.53–3.53 mm) at the end of the active phase.
During the follow-up phase in the study group, the pain score increased from 0.86 to 1.46 mm, while in the control group, the pain increased from 3.53 to 4.20 mm, and this difference was found to be statistically significant.
[Table 2]: Comparison of burning sensation scores in both groups [Figure 4]
The overall reduction in the burning score was significantly more in the study group (8.8–1.4 mm) as compared to the control group (8.7–2.9 mm) at the end of the active phase and the reduction was found to be statistically significant.
In the study group, the burning sensation score increased from 1 to 1.2 mm, while in the control group, the burning sensation increased from 3.3 to 4.20 mm during the follow-up phase. This difference was found to be statistically significant.
[Table 3]: Comparison of the size of the lesion in both groups [Figure 5]
At the start of the study, the mean size of the lesion in both groups was the same, i.e., 1.6 cm2. The therapy was started in both groups. The overall reduction in the size of the lesion was significantly more in the study group (1.6–0.4) as compared to the control group (1.6–1) at the end of the active phase and the reduction was found to be statistically significant.
In the follow-up phase, the size of the lesion in the study group showed a mild increase from 0.4 to 0.5 cm2, while in the control group for the same period, the size of the lesion increased from 1.1 to 1.4 cm2. This difference in the increase in the size of the lesion was found to be statistically significant.
[Table 4]: Comparison of Clinical resolution of the lesion in both the groups – [Figure 6]
|Table 4: Comparison of the clinical resolution of the lesion in both the groups|
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|Figure 6: Comparison of clinical resolution of the lesion in both groups|
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In the study group, a complete clinical resolution was seen in 9 out of 15 patients (60%), and in the control group, a complete clinical resolution was seen in 3 out of 15 patients (20%). So, more patients achieved a complete clinical resolution of the lesions in the active phase in the study group. During the entire follow-up phase, no further increase was noted in the number of patients who had achieved complete clinical resolution of the lesions in both groups.
[Table 5]: Comparison of recurrence of the lesion in both the groups – [Figure 7]
In the current study, out of 15 patients in the study group, 9 patients achieved complete clinical resolution of the lesions after 28 days of therapy. The recurrence was noted in 1 (11%) patient during the follow-up phase on Days 75 and 90.
In the control group, out of 15 patients, 3 patients achieved complete clinical resolution of the lesions. The recurrence was noted in 2 (66%) patients during the follow-up phase on Days 75 and 90. The difference was not found to be statistically significant, but it was clinically significant.
The study group (Group A) shows treatment with LLLT with topical steroids. [Figure 8] (a: day 0—reticular OLP present on the right buccal mucosa, b: day 28 [last day of the active phase] complete resolution of the lesion, and c: day 90 [last day of the follow-up phase] no recurrence) and [Figure 9] (a: day 0—reticular OLP present on the left buccal mucosa, b: day 28 [last day of the active phase] partial resolution of the lesion and c: day 90 [last day of the follow-up phase] no recurrence) shows pretreatment and post-treatment images, respectively.
|Figure 8: (a) Day 0: Reticular OLP present on the right buccal mucosa, (b) Day 28 (last day of the active phase) complete resolution of the lesion, and (c) Day 90 (last day of the follow-up phase) no recurrence|
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|Figure 9: (a) Day 0: Reticular OLP present on the left buccal mucosa, (b) Day 28 (last day of the active phase) partial resolution of the lesion, and (c) Day 90 (last day of the follow-up phase) no recurrence|
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| Discussion|| |
OLP is a chronic inflammatory disease that affects the mucus membrane of the oral cavity. It is a T-cell-mediated autoimmune disease in which the cytotoxic CD8+ T cells trigger apoptosis of the basal cells of the oral epithelium. The lesions of the lichen planus tend to last longer in the oral mucosa than those of the skin. Furthermore, even after going away completely, lichen planus may recur. As it heals, lichen planus often leaves a dark brown discoloration of the oral mucosa. OLP may be triggered by certain medications, mouth injury, infection, or allergy due to agents such as dental material. Stress is one of the aggravating factor leading to recurrence or worsening of the lesion.
Laxmi et al. (2015), El Shenawy H et al. (2015), Rezaei F et al. (2018), and Suman et al. (2019) reported a statistical improvement in the pain score, decrease in the burning sensation score, and statistically significant reduction in the size of the lesion in the patients treated by LLLT.
Biostimulation is a light therapy using low-level power lasers to improve wound repair and reduce the pain that utilizes non-ionizing forms of light origin, broadband light, in the visible and infrared spectrums. There is a so called optical window of the tissue - the greatest depth of the laser beam penetration in the soft tissues and the wavelength being in between 650 and 1200 nm. It can relieve pain, by making a positive effect on the immune response and stimulate lymphatic flow. In addition to the ability of photo biostimulation to stimulate blood circulation, which helps to increase the ability to absorb antibiotics in the body, the Photo bio stimulation modulation (PBM) has many features, including improvement and remodeling of the collagen in the treatment of wounds.,
The reduction in the pain score, burning sensation, size of the lesion, clinical resolution, and recurrence of the lesion in both groups attributed to the LLLT.
In the study, Dillenburg et al. (2014) and Cafaro et al. (2014) showed a complete clinical resolution of the lesions in the patients treated with LLLT. When LLLT was added to the topical steroid therapy, then a complete clinical resolution of the lesions was seen in more patients as compared to the topical steroid therapy alone. LLLT has been proposed as a non-invasive clinical tool to treat OLP, with the advantage over current therapies of not being associated with any side effects. The use of LLLT in different inflammatory conditions has potential analgesic, bio stimulatory, and immunomodulatory effects to improve healing.
Some of the studies by Köllner et al. (2003), Passeron et al. (2004), and Trehan and Taylor (2004) reported the recurrence of the lesion in a relatively shorter period. The reason probably would be a wavelength of 308 nm which has a lesser tissue penetration as compared to 810 nm which was used in the current study.
Diode laser at 810 nm possesses a deeper power of penetration reaching about 1.5 mm depth in the oral mucosa. The application of a diode laser of 810 nm in 3 W power in continuous mode will raise the temperature of the affected tissues; this temperature will cause protein denaturation. A lesser penetration would mean that the healing will occur superficially and showed recurrence of the lesions in a short time and deeper penetration would heal deeply and show minimal recurrence. The sign of protein denaturation shows blanching of the LLLT-treated mucosa.
Combination therapy showed significant promising results in patients with symptomatic OLP. An LLLP is suggested to have bio stimulating, anti-inflammatory, and analgesic effects through direct irradiation without causing a thermal response. LLLT is widely known for its safe therapeutic modality due to its non-invasive, aseptic, and painless nature.
Limitations and future prospects
The small sample size of the study. The current study consisted of 30 samples with a follow-up for 2 months. Further studies are required with a larger sample size and longer follow-ups to evaluate and confirm the findings of the current study. Also, there is a need to study the use of LLLT with different power settings and different wavelengths in the patients with symptomatic OLP to pinpoint which would be the best setting for getting the most favorable clinical outcome.
| Conclusion|| |
With changing trends in dentistry, newer treatment modalities are becoming available for managing oral mucosal disorder to the oral physician. Topical corticosteroids continue to remain the gold standard for managing patients with symptomatic OLP. But at the same time, when combined with newer treatment modalities like LLLT, the synergistic effect of both of them far exceeds the clinical benefits achieved by topical corticosteroids. Also, LLLT is non-invasive, painless in nature, aseptic with minimal side effects making it more comfortable for the patients. It has been suggested that LLLT causes biostimulation including anti-inflammatory and analgesic effects. The effect of LLLT adds up with the therapeutic effects of topical steroids resulting in a far better clinical outcome.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient (s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]