Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

NCT ID: NCT06042010

Last Updated: 2023-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2023-02-14

Brief Summary

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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

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Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test group

Group Type EXPERIMENTAL

Oral zinc supplement

Intervention Type DRUG

patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%

control group

Group Type ACTIVE_COMPARATOR

triamcinolone acetonide Oral paste

Intervention Type DRUG

patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.

Interventions

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Oral zinc supplement

patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%

Intervention Type DRUG

triamcinolone acetonide Oral paste

patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Oral medicine_0424-04\2022

Identifier Type: -

Identifier Source: org_study_id

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