Introduction

            Lemongrass oil is one of the important essential oil, extracted from Lemon grass which belongs to the section of Andropogan called Cymbopogam citratus of the family Germineae.¹ Its chemical components like phenol and flavanoid substances have reported to show many biological activities such as antibacterial, anti-inflammatory, antioxidant, antifungal, antiseptic, astringent, analgesic and carminative property.² It has proved to be a very good antioxidant agent through their free radical scavenging, nitric oxide scavenging activity, reducing ability and beta-carotene bleaching method.³

            Aloe vera (Asphodelaceae) is also a promising herb exhibiting anti-inflammatory action by inhibiting arachidonic acid pathway via cyclooxygenase. It is a mannoprotein containing many amino acids known as ‘wound healing hormones.’ The polysaccharides contained in the gel of the leaves have anti-inflammatory, immunomodulatory, antioxidant and gastro-protective properties. ⁴

Rationale of the study -

            Oral lichen planus is a common chronic immunologic inflammatory mucocutaneous disorder with a malignant transformation rate of 0-5.8%. Recent studies have reported an increased oxidative stress and lipid peroxidation in the pathogenesis of lichen planus suggesting the role of antioxidants in the treatment plan.⁵

Hypothesis -

             This research is to test the antioxidant and anti-inflammatory property of lemongrass gel and aloe vera gel in cases of oral lichen planus.

Review of literature:

1)     Kukkamalla MA et al. (2012) evaluated the antiplaque property in tissue culture plates incubated for 72 hours in 4 wells treated differently using disclosing agent, lemongrass oil mouthwash (0.25 % & 0.5%), distilled water, glodent tooth paste slurry and chlorhexidine mouthwash. Lemongrass oil mouthwash showed reduction in the plaque better than chlorhexidine and thus can be used as an adjunct to the maintenance of oral hygiene.¹

2)     Warad SB et al. (2013) evaluated the efficacy of 2% lemongrass essential oil gel as an adjunct to scaling and root planing as compared to scaling and root planing alone for the treatment of chronic periodontitis in 60 sites of 15 patients. They concluded that locally delivered 2% lemongrass essential oil gel offers a novel choice of safe and effective adjunct to scaling and root planing in periodontal therapy.²

3)     Salazar-Sánchez N et al. (2010) evaluated the efficacy of topical aloe vera in 64 patients with oral lichen planus and observed complete pain remission in 31.2 % of cases after 6 weeks and 61% after 12 weeks.⁶

4)     Mansourian A et al. (2011) compared the therapeutic effects of aloe vera mouthwash with triamcinolone acetonide (0.1%) on oral lichen planus. 74% of patients in aloe vera group and 78% patients in triamcinolone acetonide group showed degrees of healing.⁷

Aim and objectives

Aim:

         To evaluate the effectiveness of lemongrass gel and aloe vera gel in the treatment of oral lichen planus.

Objectives:

       1) To compare the efficacy of lemongrass gel and aloe vera gel as a novel treatment of choice in oral lichen planus.

        2) To establish the role of lemongrass oil as an antioxidant and anti-inflammatory agent in the treatment of oral lichen planus.

       3) To establish the role of aloe vera as an antioxidant and anti-inflammatory agent in the treatment of oral lichen planus.

Material and methods:⁸

Trial design – Randomized controlled trial with parallel group trial design.

Participants -

Place of study – Department of Oral Medicine and Radiology, Dental Institute, RIMS

Eligibility criteria –

             A total of 200 cases (age group >18 years) of clinically diagnosed oral lichen planus will be enrolled for the study from the department of Oral Medicine and Radiology, Dental Institute, RIMS, Ranchi. This will be a double blinded randomized clinical trial undertaken for a period of 3 months where the study group will be randomly divided into 2 subgroups:

Group 1 – 100 cases treated with lemongrass gel

Group 2 – 100 cases treated with aloe vera gel.

Inclusion criteria – Clinically diagnosed cases of oral lichen planus.

Exclusion criteria –

ü  Allergy to lemon grass/ aloe vera or its derivatives

ü  Pregnancy/ Lactation

ü  Systemic illnesses such as diabetes, hypertension and thyroid disorders

ü  Patient who have undergone treatment for any kind of systemic disease in the last 3 months

ü  Patient taking topical/ systemic steroids for the past 1 month

ü  Patients having any immunosuppressive disorder/ medication

ü  Any existing malignancy of the oral cavity

     The patients will be explained about the importance of the study and informed consent taken for the same.

Interventions -

Biological authentication of both the plants were done.

Preparation of lemongrass gel

5% lemongrass gel will be prepared. Appropriate quantity of carbopol 934 (gelling agent) is soaked in water for a period of 2 hours. Carbopol is then neutralized with triethanolamine by stirring. Then 5ml lemongrass essential oil is dissolved in appropriate and pre-weighted amounts of propylene glycol and ethanol. The solvent blend is transferred to carbopol container and agitated for an additional 20 min. The dispersion is then allowed to hydrate and swell for 60 min, and finally the pH adjusted with 98% triethanolamine until the desired pH value is approximately reached (6.8-7). During pH adjustment, the mixture is stirred gently with a spatula until a homogeneous gel is formed. 50ml sorbitol is added as an artificial sweetener and stirred well to neutralize the bitterness of lemongrass oil.

Preparation of aloe vera gel

The leaves of aloe vera are collected, washed with water and a mild chlorine solution and finally cut transversely into pieces. With a vegetable peeler, the thick epidermis is selectively removed and the inner gel-like pulp in the center of the leaf is separated with a spoon, minced and homogenized in a mixer to obtain aloe vera extract. To prepare aloe vera gel, sodium metabisulphite, methyl paraben sodium and propyl paraben sodium are dissolved in water. Gelling agent is added to it and stirred continuously till it gets swollen completely. Triethanolamine is then slowly added to the dispersion with continuous stirring which results in a stiff gel. Aloe extract was added to it and stirred for 15 min. Volume is made with water and stirred continuously till a uniform gel is formed.

Adverse effects of the drugs:

Outcomes -

Primary outcome - The patients will be followed up after 15, 30, 45 days, 2 and 3 months. Response will be evaluated based on visual analog scale, burning sensation and Thongprasom criteria.

Thongprasom scoring system:⁹

      0- Normal mucosa,

1-     mild white striae, no erythematous area,

2-     white striae with atrophic area less than 1cm2,

3-     white striae with atrophic area more than 1cm2,

4-     white striae with ulcerative area less than 1cm2,

5-     white striae with ulcerative area less than 1cm2.

Sample size -

X = z²pq/ e²

z = constant, 95% confidence interval, value - 1.96

p = prevalence = 2.2% = 0.022

q = 1- p = 0.978

e = error in judging = 2% = 0.02

X = 206.6 = 200 subjects (approximately)

Randomization –

Both the gel preparations will be dispensed in small disposable containers and labeled as “A” and “B.” All the subjects will be distributed the medications in a double blinded technique and will be asked to topically apply the medications over the lesional area thrice a day for a period of 3 months.

Blinding – Double blinded study.

          Both the gel preparations will be prepared elsewhere in a private health center. All the participants will be allocated a disposable container labelled A or B alternatively. The investigator and the participant both will be unaware of the gel provided.

Statistical methods:

       All the data obtained will be recorded in a proforma specially designed for the study and subjected to statistical analysis. Student’s paired t-test will be performed to test the mean changes in scores at different time intervals within each study group. One-way analysis of variance (ANOVA) will be used to compare the mean scores between different study groups.

Acknowledgement: We would like to thank Amrita Family Health Centre, Ranchi for their kind and generous support in the preparation of lemongrass oil gel and aloe vera gel.

References

1)     Kukkamalla MA, Bhat GS, Pentapati KC, Goyal R. Antiplaque Efficacy of Lemongrass Oil Mouthwash – An invitro Study. Global Journal of Medical Research 2012;12(7):19-23.

2)     Warad SB, Kolar SS, Kalburgi V, Kalburgi NB. Lemongrass essential oil gel as a local drug delivery agent for the treatment of periodontitis. Ancient Sci Life 2013;32: 205-11.

3)      Lawrence R, Lawrence K, Srivastava R, Gupta D. Antioxidant activity of lemon grass essential oil (Cympopogon citratus) grown in North Indian plains. The scientific temper 2015;IV: 23-9.

4)     Sujatha G, Kumar GS, Prasad TS. Aloe vera in dentistry. J Clin Diagn Res. 2014;8(10): Z101-2.

5)     Hassan I, Keen A, Majid S, Hassan T. Evaluation of the antioxidant status in patients of lichen planus in Kashmir valley – A hospital based study. Journal of the Saudi Society of Dermatology & Dermatologic Surgery 2013;17:13-6.

6)     Salazar-Sánchez N, López-Jornet P, Camacho-Alonso F, Sánchez-Siles M. Efficacy of topical Aloe vera in patients with oral lichen planus: a randomized double-blind study. J Oral Pathol Med. 2010;39:735-40.

7)     Mansourian A, Momen-Heravi F, Saheb Jamee M, Esfehani M, Khalilzadeh O, Momen Beitollahi J. Comparison of aloe vera mouthwash with triamcinolone acetonide 0.1% on oral lichen planus: a randomized double blinded clinical trial. Am J Med Sci. 2011;342:447-50.

8)     Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.

9)     Yiemstan S, Krisdapong S, Piboonratanakit P. Association between Clinical Signs of Oral Lichen Planus and Oral Health-Related Quality of Life: A Preliminary Study. Dent J (Basel). 2020;8(4):113.

Annexure I

CASE RECORD FORM

Name                                                                                      Age/Sex

Occupation                                                                             Address

Chief complaint

History of present illness

Medical history

Personal history

Examination of the lesion in detail

Diagnosis

Treatment given

Follow up

Burning sensation: 0- No burning sensation, 1 - Burning sensation on having normal food , 2 - Burning sensation on having spicy food.

Thongprasom criteria: 0- Normal mucosa, 1- mild white striae, no erythematous area, 2- white striae with atrophic area less than 1cm², 3 - white striae with atrophic area more than 1cm², 4 – white striae with ulcerative area less than 1cm², 5- white striae with ulcerative area less than 1cm².