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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 17  |  Issue : 4  |  Page : 141-145

The effect of oleozone gel vs triamcinolone acetonide in ora base on the treatment of erosive/atrophic lichen planus in medically compromised patients


1 Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Faculty of Dentistry, Tanta University, Tanta, Egypt
2 Department of Clinical Pathology, Faculty of Medicine, Tanta University, Tanta, Egypt

Date of Submission11-Jan-2020
Date of Acceptance03-Mar-2020
Date of Web Publication22-Jan-2021

Correspondence Address:
Mona A El Meligy
Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology, Faculty of Dentistry, Tanta University, Tanta
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/tdj.tdj_1_20

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  Abstract 

Background
Oral lichen planus (OLP) is a common T–cell mediated chronic inflammatory disease, with unknown etiology. One of the etiological factors is involvement of some systemic diseases such as liver disease, diabetes mellitus, and hypertension. The immune system disturbances and oxidative stress may play a role in its pathogenesis. Corticosteroids are the mainstay for treatment of OLP and have its side effects. Oleozone gel was another suggested medication used to treat OLP.
Aim
The aim was to evaluate the beneficial effect of oleozone gel in the treatment of atrophic/erosive lichen planus in medically compromised patients and to compare it with the effect of triamcinolone acetonide in ora-base as a gold standard treatment.
Materials and methods
Twenty patients with symptomatic atrophic/erosive OLP were medically compromised and randomly assigned for treatment with 0.1% triamcinolone acetonide gel (group 1) or oleozone gel (group 2). The pain score (visual analog scale) and tumor necrosis factor-α were assessed at baseline (before treatment), 1 month and 3 months.
Results
Showed nonsignificant differences between the two treatment groups in reducing visual analog scale score and tumor necrosis factor-α value.
Conclusion
The study revealed that oleozone gel was found to be effective as triamcinolone acetonide in ora-base (0.1%) gel in the treatment of atrophic/erosive OLP in medically compromised patients.

Keywords: corticosteroid, free radicals, medically compromised patients, oleozone gel, oral lichen planus


How to cite this article:
El Meligy MA, El-Zefzaf EA, Ghoraba SF, El-Zamarany EA. The effect of oleozone gel vs triamcinolone acetonide in ora base on the treatment of erosive/atrophic lichen planus in medically compromised patients. Tanta Dent J 2020;17:141-5

How to cite this URL:
El Meligy MA, El-Zefzaf EA, Ghoraba SF, El-Zamarany EA. The effect of oleozone gel vs triamcinolone acetonide in ora base on the treatment of erosive/atrophic lichen planus in medically compromised patients. Tanta Dent J [serial online] 2020 [cited 2021 Sep 20];17:141-5. Available from: http://www.tmj.eg.net/text.asp?2020/17/4/141/307801


  Introduction Top


Oral lichen planus (OLP) is a T-cell mediated chronic inflammatory oral mucosal disease[1]. Although exact etiology of OLP is unknown, in most cases a multifactorial process is considered to be involved, with the participation of genetic, psychological, and infectious factors[2].

Liver disease, diabetes mellitus (DM), and hypertension were considered among the etiological factors. It was suggested that there is association between DM and OLP based on immunologic changes observed in both diseases. It was suggested that there is association between DM and OLP based on immunologic changes observed in both diseases. The reported frequency of OLP in DM varies from 1.6 to 85%[3].

Also, the association between OLP and chronic liver disease is still controversial. However, there is a strong association between it and hepatitis C viral (HCV) infection based on geographical heterogeneity[4],[5],[6],[7]. Also, individuals with type II DM have an increased prevalence of liver cirrhosis and patients with acute and chronic liver disease develop DM[5].

Recently it has been suggested that increased reactive oxygen species (ROS) and lipid peroxides may play a part in the pathogenesis of various diseases such as OLP[8]. The immune dysregulation in OLP is reflected to a large extent by the aberrant productions of a great range of inflammatory mediators both in the local lesions and peripheral blood which may play important regulatory roles in the interactions between keratinocytes, T cells and many other cell types[9],[10],[11].

Cytokines can stimulate production of ROS. The presence of apoptosis is a hallmark feature in lichen planus and this indicates that ROS may play a crucial role in the disease process as ROS are essential mediators of apoptosis[12],[13]. Tumor necrosis factor-α (TNFα) is obviously the most extensively studied cytokine in OLP. TNFα can induce the secretion of interleukin 6 and interleukin 8 by several cell types[14],[15]. Because OLP is a T cell mediated inflammatory disease, TNFα may be involved in the pathogenesis of OLP[16].

HCV infection is a global health problem: 170 million persons may be infected worldwide, and the proportion of HCV-positive individuals varies from less than 1% in Northern European Countries to greater than 15% in Egypt. The peculiar differences in heterogeneity in geographic regions seen in the association of LP and HCV is difficult to explain and has been hypothesized to be the result of differences in genetic factors such as different human leukocyte antigen types[17],[18] and different HCV genotypes have variable degrees of pathogenic potential for the development of OLP. Socioeconomic factors may also be expressed in the geographic differences[19].

The association between DM, LP especially OLP and hypertension[20] has been the subject of many researches but the conclusion is controversial. The main aim of OLP treatment is to control the symptoms and eliminate the precipitating factors. Topical corticosteroids drugs are the mainstay of OLP treatment and have been recommended. Triamcinolone acetonide in ora-base was used as the common standard treatment as it is commercially available[21].

With the advancements in the field of medicine, new treatment protocols are budding to combat human ailments in a much natural better and simple way. One such advancement is the application of ozone in the treatment of oral lesions.

Ozone is known as triatomic oxygen naturally found as gas in the upper atmosphere. The properties of Ozone are dependent on systemic conditions like temperature and pressure. Medical grade ozone is a mixture of pure oxygen and pure ozone in the ratio of 0.05–5% of O3 and 95–99.95% of O2[22].

Ozone inhalation can be toxic to the pulmonary system and other organs. Known side effects are epiphora, respiratory irritation, rhinitis, cough, headache, occasional nausea, vomiting, shortness of breath, blood vessel swelling, poor circulation, heart problems, and at a times stroke. Because of ozone high oxidative power, all materials that in contact with the gas must be ozone resistant[22],[23].

Ozonized water and ozone gas both have short life-times, as ozone rapidly decays to oxygen (4–6 h) at room temperature. Both should be made for fresh application and use[24]. Ozonized oils exhibit ∼45–50% ozone gas activity, depending on the base plant oil used and the degree of conversion. It should be noted that the influence of ozone lead to a higher expression of cytokines that are important for wound healing[25].

Ozone can modulate the immune system as it increases and activates body's own antioxidants and radical scavengers. It is utilized in the treatment of various allergic diseases[26]. Ozone is also a powerful antioxidant and radical scavenger[27], where direct contact of oleozone gel with host cells decrease the release of ROS as a part of the immune response as excessive production of this products leads to damage of the tissue by oxidizing DNA, lipids, and proteins[28].

Treatment of OLP remains a great challenge for clinicians. This study aimed to evaluate and compare the effect of oleozone gel vs triamcinolone acetonide in ora-base on the treatment of atrophic/erosive lichen planus in medically compromised patients.


  Materials and methods Top


The study was carried out in the Department of Oral Medicine, Faculty of Dentistry, Tanta University. All patients gave written informed consent. Twenty patients were assessed according to the eligibility requirements. They are either treated for the first time or had stopped any previous treatment for at least 6 months before beginning of the study treatments. They were medically compromised hepatic, diabetic, or hypertensive. Pregnant women, smokers, patients suffer from another autoimmune disease or ozone allergy were excluded.

Patients were divided into two groups of ten in each group I treated with topical triamcinolone acetonide in ora base gel (0.1%; Bristol Mayerrs Squibb/Squibb, Boston, Massachusetts, USA), and group II treated with oleozone gel (OZOMAX Inc. Robitaille Shefford, Québec, Canada). Both treatments were applied on the mucosa on sterile gauze after meals and at bed time (four times/day) for 1 week. Patients were informed not to drink or eat for 30 min after application of the drugs. The effect of the study treatments was evaluated clinically by visual analog scale (VAS) and immunobiochemical by measuring serum TNFα at baseline, 1 month and 3 months.

The collected data were organized, tabulated, and statistically analyzed using SPSS version 19 (Statistical Package for the Social Studies created by IBM, Illinois, Chicago, USA.). The differences between mean values of the two studied groups were tested used using Student's t test. The level of significant was adopted at P less than or equal to 0.05.

Clinical assessment

The pain or burning sensation was self-assessed by patient from 0 (no pain) to 10 (extreme pain) at the baseline, 1 and 3 months of therapy using VAS. Patients marked the point representing their present pain perception.

Immunobiochemical assessment

ELISA (R and D Systems Inc., Minneapolis, Minnesota, USA) used for the quantitative measurement of TNFα in patient's serum according to the manufacture. Blood samples were collected from each patient and serum was separated from samples. The samples were taken at base line, 1 and 3 months post-treatment.


  Results Top


Data showed that, there was a statistically significant reduction in VAS along the evaluation period in both groups as compared to the base line (P ≤ 0.05). But by comparing the mean value of VAS at 3 months in group 1 and group 2 vs the mean value of VAS at 1month in group 1, in group 2 there was no statistically significant increase in VAS score in group 1 as showed in [Table 1].
Table 1: The mean value of visual analog scale in groups (1 and 2) at baseline, 1, 3 months post-treatments and 1 month vs 3 months

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As regard results showed nonstatistically significant reduction in TNFα value at 1 month compared to baseline in group 1 and 2, respectively, also and there was increase in TNFα value at 3 months compared to baseline in group 1 and 2, respectively. But by comparing the mean value of TNFα at 3 months vs 1 month there was nonstatistically significant increase in TNFα value (P = 0.3466) [Table 2].
Table 2: The mean values of tumor necrosis factor-α in group (1 and 2) at baseline, 1,3 months post-treatment and 1 month vs 3 months

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Comparing the study group results

The results showed that both treatment modalities were effective in reducing the pain along the evaluation period but have no effect on reducing serum level of TNFα in medically compromised patients (HCV, DM, and hypertension) affected with OLP.


  Discussion Top


Several treatment modalities for treatment of OLP including systemic[29] and topical agent[20],[21],[22],[23],[24],[25],[26],[27],[28],[29],[30],[31],[32]. However, most of these studies reported that corticosteroids either systemic or topical are the mainstay of palliative treatment in most of OLP symptoms [33-35]. However, steroids was contraindicated in some patients who have certain medical problem. So in this study a topical antioxidant and immunomodulatory drug was selected for treatment of this disorder as alternative when topical corticosteroids are contraindicated as in medically compromised patients. Oleozone gel is one of the modern antioxidant non-medication methods of treatment resulting in clinical improvement in diseases induced by oxidative stress like LP according to Sezer et al.[36] and Anshumalee et al.[37] Also, ozonated olive oil gel was selected in accordance with Kim et al.[38], Kumar et al.[39] and Campanati et al.[40].

In the present study, all the 20 (100%) patients had HCV infection, 10 (50%) patients out of those patients had also DM type II and two (10%) patients had hypertension besides there HCV infection. This was incomitant with Carrozzo et al.[40], Del Olmo et al.[41], and Mahboobi et al.[42] who requested serological tests for patients diagnosed with OLP is of marked importance as those patients are asymptomatically appeared but serious complications may result in them if left untreated, therefor screening patients with erosive OLP permits an early diagnosis and better prognosis of associated diseases. Mostafa and Ahmed[2], who reported that an epidemic association between OLP and HCV as anti-HCV circulating antibodies appear to be more common in patients with OLP.

In this study, there was a statistically significant improvement in pain score (VAS) in both treatment groups along study periods. This was in accordance with other studies which reported that topical steroids are the most effective treatment with promising outcomes in pain/soreness relief and are the main treatment for vesiculoerosive diseases of oral mucosa including OLP to reduce pain and inflammation[43]. This could be explained by the anti-inflammatory action of corticosteroid through synthesis of lipocortin-1 which inhibits phospholipase A2 so decrease arachidonic acid and decrease synthesis of prostaglandins, decrease capillary permeability and inflammatory edema by inhibiting activity of kinins and bacterial endotoxins and decreasing histamine release.

Also, our results were in line with El Shenawey and Mohy Eldin[44] who evaluated the effect of low-level laser vs triamcinolone acetinoide in treatment of erosive OLP. They reported that topical corticosteroid showed significant improvement in pain score than laser group till the end of evaluation period.

The significant improvement in group 2 (oleozone group) at 1 month and 3 months compared to baseline could be attributed to the effectiveness of ozone mechanism in reducing the pain plus its beneficial effect on accelerating the wound healing. This may be due to its property in prevention of the adhesions between erythrocytes which improve its elasticity. This improvement in property of erythrocytes activity enable them to return oxygen in the inflamed tissue through fine capillaries raising the possibility of ozone as therapeutic agent in inflammatory diseases[45],[46].

Additionally, Ozone as powerful antioxidant therapy when contact with host cells decreases the release of ROS as a part of the immune response. Leading to enhancement of wound healing through shortening of initial wound healing time, the enhancement of phagocytic activity of defending cells, accelerating migration of epithelial cells and activation of fibroblasts for collagen synthesis[47],[48].

Also, ozone modulates the immune system as it increases and activates body's own antioxidants and radical scavengers, due to its immunomodulating effects[47]. However, from our knowledge of view there are no data concerned in the effect of oleozone gel in the treatment of erosive OLP to compare our results.

In our study TNFα was selected for immunological assessment as evidenced by several studies who reported high serum levels of TNFα in all patients with OLP simultaneously with the expression of other proinflammatory cytokines[49],[50],[51],[52],[53]. The levels of can be quantified using ELISA which is more sensitive, reliable, simple, and widely used and very little sample is required for estimation[51].


  Conclusion Top


Oleozone gel is safe as topical triamcinolone acetonide in ora-base (0.1%) for oral application (four times/day for 1 week) without any adverse reactions and compatible with the oral tissues. Also, oleozone gel could be the alternative treatment of atrophic/erosive OLP especially in patients who were contraindicated to be treated by corticosteroids as medically compromised. Both topical triamcinolone acetinoide gel 0.1% and oleozone gel were not effective in reducing serum TNFα in the medically compromised patient.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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