Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06042010
• Other study ID #: Oral medicine_0424-04\2022
• Status: Completed
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: February 14, 2023

Study information

• Verified date: September 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• Oral zinc supplement
patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%
• triamcinolone acetonide Oral paste
patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 weeks, 12 weeks
Primary	Change in MMP-9 level	Whole unstimulated saliva will be collected from all participants	Baseline, 6 weeks, 12 weeks
Secondary	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	Baseline, 6 weeks, 12 weeks