Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

Not Applicable

Completed

• Conditions: Oral Lichen Planus
• Interventions: Drug: Oral zinc supplement; Drug: triamcinolone acetonide Oral paste

• Registration Number: NCT06042010
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-05
• Primary Completion: 2023-02-14
• Study Completion: 2023-02-14
• Status Verified: 2023-09
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-12
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Oral zinc supplement	-
control group	triamcinolone acetonide Oral paste	-

Primary Outcome Measures

Name	Time	Method
Change in MMP-9 level	Baseline, 6 weeks, 12 weeks	Whole unstimulated saliva will be collected from all participants
Change in oral lesions	Baseline, 6 weeks, 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in pain	Baseline, 6 weeks, 12 weeks	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

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt