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OpenTrials
Completed

NCT Number: NCT06042010

Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

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.

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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral zinc supplement

Drug

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

triamcinolone acetonide Oral paste

Drug

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

Primary outcomes

  1. Change in oral lesions

    Time frame: 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.

  2. Change in MMP-9 level

    Time frame: Baseline, 6 weeks, 12 weeks

    Whole unstimulated saliva will be collected from all participants

Secondary outcomes

  1. Change in pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 18, 2023
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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