Status:
UNKNOWN
Effect of Oral Zinc Supplementation as an Adjuvant to Topical Corticosteroid in Oral Lichen Planus Patients
Lead Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Conditions:
Oral Lichen Planus
Eligibility:
All Genders
Phase:
PHASE4
Brief 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 ...
Detailed Description
Lichen planus is a chronic muco-cutaneous disorder of the stratified squamous epithelium that affects the oral and genital mucous membrane, skin, hair, nails and scalp.OLP is the mucosal counterpart o...
Eligibility Criteria
Inclusion
- Clinically and histopathologically proven cases of erosive and atrophic OLP.
- Patients who are willing to participate in the study.
Exclusion
- Patients with reticular form of OLP and OLP with muco-cutaneous involvement.
- Patients consuming drugs for the treatment of OLP in the past 6 months.
- Suspected lichenoid reaction associated with drugs and restorations.
- Patients whose histopathological findings indicate moderate to severe dysplasia.
- 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.
- Patients with systemic diseases involving the gastro-intestinal tract.
- Known cases of Acrodermatitis enteropathica where difficulty in zinc absorption persists.
- Presence of factors that can alter the absorption of zinc like consumption of calcium tablets, iron supplements and high protein diet.
- Pregnancy and lactation phase
- Alcoholic patients, since alcoholism results in intracellular zinc deficiency.
- Recorded allergy to zinc and/or corticosteroids.
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04278599
Start Date
January 15 2020
End Date
September 30 2020
Last Update
July 21 2020
Active Locations (1)
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1
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, India, 124001