Effect of Oral Zinc Supplementation as an Adjuvant to Topical Corticosteroid in Oral Lichen Planus Patients

• Status: Recruiting
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Lichen planus is an auto-immune, chronic inflammatory disease that affects mucosal and cutaneous tissue. Erosive and atrophic oral lichen planus (OLP) are difficult to manage because patients present with symptoms ranging from episodic pain to severe discomfort and they have the highest malignant transformation rate (MTR) amongst all the forms of OLP. Zinc is associated with regeneration of epithelium, wound healing and mediating T-lymphocyte function; all of which can lead to healing and re-epithelisation in the lesions of erosive OLP. Besides this, it also has anti-oxidant and anti-inflammatory properties, which lead to decrease in apoptosis and transformation into a malignant state.

This study intends to evaluate the effect of oral zinc supplements as an adjuvant to the topical corticosteroid therapy in the treatment of OLP.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Treatments: Zinc

Criteria

Inclusion Criteria:

1. Clinically and histopathologically proven cases of erosive and atrophic OLP.

2. Patients who are willing to participate in the study.

Exclusion Criteria:

1. Patients with reticular form of OLP and OLP with muco-cutaneous involvement.

2. Patients consuming drugs for the treatment of OLP in the past 6 months.

3. Suspected lichenoid reaction associated with drugs and restorations.

4. Patients whose histopathological findings indicate moderate to severe dysplasia.

5. Patients with acquired and congenital immuno-deficiency disorders like AIDS, chemotherapy, addiction to injectable opioids like hemophilia and blood dialysis. These patients are excluded because of difficulty in their biopsy procedure, control of infection, possible interaction with clinical findings of OLP, and their potential doubtful cooperation.

6. Patients with systemic diseases involving the gastro-intestinal tract.

7. Known cases of Acrodermatitis enteropathica where difficulty in zinc absorption persists.

8. Presence of factors that can alter the absorption of zinc like consumption of calcium tablets, iron supplements and high protein diet.

9. Pregnancy and lactation phase

10. Alcoholic patients, since alcoholism results in intracellular zinc deficiency.

11. Recorded allergy to zinc and/or corticosteroids.