To test the effectiveness of two commonly used medicines in Oral Lichen Planus and to study their molecular interactions.

Not yet recruiting

Conditions: Diseases of oral cavity and salivary glands,

Registration Number: CTRI/2023/08/056156

Lead Sponsor: MGM Dental College and Hospital

Brief Summary: Oral Lichen Planus (OLP) is a chronic mucocutaneous, auto immune disease where the etiology remains unclear. The global prevalence of OLP is up to 2%. In India the prevalence is reported to be 2.6%.It affects women 2 to 3 times more commonly than men on average between the 30 to 70 years of age. OLP can be either asymptomatic or symptomatic, and when symptomatic, can range from mild sensitivity to significant pain that impacts quality of life. The most involved sites are the buccal mucosa, borders and dorsum of the tongue and gingiva. The bilateral and symmetric distribution is typical of OLP. The hard and soft palate, lips, and floor of the mouth are rarely affected. Clinically OLP is characterized by lesions consisting of radiating white, grey, velvety, thread-like papules in a linear, annular and retiform arrangement. OLP can present itself in reticular, having characteristic Wickham striae, atrophic (erythematous) or erosive (ulcerative) forms. Patients with reticular lesions are often asymptomatic, but atrophic or erosive OLP is often associated with a burning sensation and pain.Pathogenesis of OLP is often associated with T cell mediated immunological dysfunction. Antigen-specific and nonspecific mechanisms are involved in the pathogenesis of OLP. The activated helper T cells produce IL-2 and interferon (IFN)-gamma and lead to the proliferation and activation of cytotoxic T lymphocytes, which cause the apoptosis of basal keratinocytes and the degeneration of basal epithelial cells. IL-17 activates a proinflammatory cascade that leads to recruitment of T lymphocytes. TNF-alpha is involved in the migration of T cells from the capillaries into the surrounding extracellular matrix. Management of OLP is aimed at reducing symptoms and the manifestation of lesions. The treatment modalities for OLP can be pharmacological treatment, non- pharmacological modalities or adjuvant therapy with phytochemicals. Pharmacological treatment includes topical or systemic corticosteroids, retinoid, dapsone, cyclosporine, calcinuerin inhibitors. Corticosteroids are most commonly used for the treatment of OLP because of their action in suppressing cell-mediated immune activity. They have anti-inflammatory properties that helps in reducing edema and lymphocytic exudation, prevents swelling and cell damage by inhibiting phagocytosis tissue damage and fibrosis. Topical corticosteroids effectively penetrate the squamous epithelium and have less severe side effects than systemic corticosteroids. Triamcinolone acetonide paste is the most widely available commercial corticosteroid for the treatment of OLP . Topical calcineurin inhibitors like cyclosporine, tacrolimus (TAC) or pimecrolimus are considered as an alternative to treat recalcitrant cases of OLP. Calcineurin inhibitors are immunomodulators that bind to intra-cytoplasmic proteins in T-lymphocytes which in turn inhibit calcineurin, leading to suppression of transcription and production of variable cytokines and suggesting a possible role of these agents in management of variable immune-mediated lesions Also recent systematic reviews and meta-analysis have concluded that topical tacrolimus is a safe and effective alternative to topical corticosteroids for OLP treatment.Tacrolimus inhibits mediators released from basophil and mast cell, along with that it stops activities for calcineurin phosphatase enzymes, which hinder formation and secretions of IL-2 and tumour necrosis factor Î±, finally inhibiting the multiplication of T cells.Several other therapeutic modalities have been used with varying efficacy which includes general measures (good oral hygiene, antibacterial mouthwash, and antifungal agents), psoralen plus ultraviolet A light (PUVA), griseofulvin, hydroxychloroquine and dapsone (1, 3). Also, ozone therapy, cryotherapy with nitrous oxide gas (NOG), photodynamic therapy (PDT), and low-level laser therapy (LLLT), also called photobiomodulation (PBM), have been proposed for patients with symptomatic OLP.Also trends toward drugs of natural or herbal origin like curcumin, aloe vera, honey, chamomile have been considered for the treatment of OLP. since phytochemicals have been found to possess potent anti-inflammatory, antioxidant and anti-carcinogenic properties. Understanding the pathogenesis of a condition is essential for targeted treatment and better prognosis. Being reproducible, in silico methods can serve as initial screening platforms for assessing the efficacy of drugs and drug repurposing through molecular docking. Through in silico analysis we will understand the interaction of drug at target site and co-relate this with its clinical outcome. Although a wide spectrum of therapeutic options are available for treatment of OLP, none are completely curative because of the recalcitrant nature and idiopathic etiology of the disease. Although first line of therapy for treating symptomatic OLP is corticosteroids, several alternative treatment modalities are also effective. Phytochemicals are also used as adjuvant therapy in cases of OLP. Thus, the aim of the present study is to compare the efficacy of topical 0.1% Triamcinolone acetonide and topical 0.1% Tacrolimus in the management of symptomatic Oral Lichen Planus and study their mode of action by in-silico analysis which can predict the types of targets these drug compounds (ligands) can bind efficiently to. This maybe clinically significant in targeted therapeutics and help explore the potential side effects resulting from off target intervention.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 34

Inclusion Criteria

Clinico- histopathologically diagnosed cases of Oral Lichen Planus.
Patients with symptoms of pain and burning sensation secondary to Oral Lichen Planus.
Patients willing to participate in the study.

Exclusion Criteria

Topical or systemic medication for treatment of Oral Lichen Planus up to 4 weeks prior to the study Histopathological examination with atypical or lichenoid dysplastic features.
Patients with asymptomatic oral lesions.
Patients with other mucosal diseases.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To check and compare the reduction in clinical signs and symptoms of Oral Lichen Planus on application of treatment agents during the course of followup	0,2,4,6,8 weeks

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): MGM Dental College and Hospital
🇮🇳
Raigarh, MAHARASHTRA, India
MGM Dental College and Hospital
🇮🇳Raigarh, MAHARASHTRA, India
Dr Anupama Warrier
Principal investigator
9986089946
anu_warrier@ymail.com