Clinical trial

Efficacy of Oral Zinc Supplement as an Adjunctive Therapy for Erosive Oral Lichen Planus (a Randomized, Controlled Clinical Trial)

Name
Oral medicine_0424-04\2022
Description
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.
Trial arms
Trial start
2023-01-05
Estimated PCD
2023-02-14
Trial end
2023-02-14
Status
Completed
Treatment
Oral zinc supplement
patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%
Arms:
Test group
triamcinolone acetonide Oral paste
patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.
Arms:
control group
Size
22
Primary endpoint
Change in oral lesions
Baseline, 6 weeks, 12 weeks
Change in MMP-9 level
Baseline, 6 weeks, 12 weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}
Updated at
2023-09-18

1 organization

2 products

1 indication

Product
Zinc