Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

N/ACompletedNCT06042010

Hams Hamed Abdelrahman22 enrolled

Overview

Lichen Planus (LP) is a chronic mucocutaneous inflammatory disease and considered as T-cell mediated autoimmune disorder. Zinc is a potent antioxidant micronutrient that contributes to the proper functioning of the antioxidant defense system. In addition, this mineral protects cells against inflammation by oxidative stress, because it acts in the stabilization of cell membrane. It also maintains macrophage and neutrophil functions, natural killer cell activity, and complement activity. Matrix metalloproteinases (MMPs) are a family of zinc-containing endopeptidases and have the main function of proteolytic degradation of connective tissue matrix proteins. Zinc prevents (MMP-1) activation and inhibition of the T-cell accumulation in (OLP) through inhibiting of (MMP-9). Aim of the study: To evaluate and compare the efficacy of adding oral zinc supplementation 50 mg to 0.1%Triamcinolone orabase (TA)versus 0.1%Triamcinolone orabase alone on the healing of erosive OLP.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Oral Lichen Planus

Interventions

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients involved in this clinical trial will have symptomatic OLP Exclusion Criteria: * Smokers or tobacco users will be excluded from this clinical trial. * Pregnant and lactating females. * Any patient that has history of cancer, kidney, liver or other autoimmune disease will be excluded from this study. * Patients showing dysplastic changes in their confirmatory biopsy specimen will be also excluded. * Any patients presenting with extra oral lichen planus lesions will be excluded. * Suspicious lesions of both lichenoid contact reaction and lichenoid drug reaction lesions will be excluded. * Vitamin administration intake within the last 3 months

Outcomes

Primary Outcomes

Change in oral lesions

Thongprasom scoring system will be used for the measurement of objective outcomes; score 5 was assigned to patients having white striae with erosive areas \>1 cm2, score 4 assigned to patients with white striae and erosive areas \<1 cm2, score 3 assigned to those having white striae and atrophic areas \>1 cm2, score 2 assigned to those having white striae and atrophic areas \<1 cm2, score 1 assigned to those having only white striae, and score 0 assigned to normal mucosa.

Time frame: Baseline, 6 weeks, 12 weeks

Change in MMP-9 level

Whole unstimulated saliva will be collected from all participants

Time frame: Baseline, 6 weeks, 12 weeks

Secondary Outcomes

Change in pain

Patients will be asked to assign a numerical score representing the intensity of their symptoms on a scale from 0 to 10, with 0 being no symptoms and 10 being worst imaginable symptoms

Time frame: Baseline, 6 weeks, 12 weeks

Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes