Effect of Oral Zinc Supplementation as an Adjuvant to Topical Corticosteroid in Oral Lichen Planus Patients
NCT ID: NCT04278599
Last Updated: 2020-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
42 participants
INTERVENTIONAL
2020-01-15
2020-09-30
Brief Summary
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This study intends to evaluate the effect of oral zinc supplements as an adjuvant to the topical corticosteroid therapy in the treatment of OLP.
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Detailed Description
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OLP is a potentially pre-malignant oral epithelial lesion. It is a T-cell mediated auto-immune disease in which the auto-cytotoxic CD8 + T cells trigger the apoptosis of the basal cells of oral epithelium.OLP is an idiopathic disease, although there are certain precipitating factors like HLA-A3, anxiety \& stress, diabetes and hypertension.
OLP occurs bilaterally, the most common sites being buccal mucosa, tongue, lips, gingiva, floor of mouth and palate. Wickham's striae are a pathogonomic feature. It has six clinical presentations- Reticular, Erosive, Atrophic, Plaque-like, Papular and Bullous.The reticular form is most common but its asymptomatic, while the erosive form is most severe with symptoms ranging from mild burning to severe pain. The range of MTR for OLP is about 0-5%, with the highest rate for erosive and atrophic types.Erosive OLP lesions arise as a complication of the atrophic process after trauma or ulceration. Appear as a central area of erosion with yellowish fibrinous exudate surrounded by erythema, with Wickham's striae in the periphery. Atrophic OLP lesions appear bright red due to loss of epithelium.
A review study done on the recent concepts in the treatment of OLP concluded that corticosteroids (mostly topical, rarely systemic) continue to be the mainstay of management of OLP. However, there are some other drugs which have a significant contribution such as- Calcineurin inhibitors (cyclosporine, tacrolimus, pimecrolimus), Retinoids, Dapsone, Hydroxychloroquine, Mycophenolate mofetil and Enoxaprin. The non-pharmacological treatment modalities include PUVA therapy, photodynamic therapy and laser therapy.
A recently conducted study found out that serum zinc levels were significantly decreased in patients with erosive OLP in comparison with patients of non-erosive OLP, which may be responsible for disintegration of epithelium in erosive OLP lesions.
The association of OLP and zinc lies in the fact that zinc is associated with the regeneration of epithelium, enhancement of enzyme activity, contributes to protein structure, helps in wound healing as well as inhibition and stimulation of lymphocyte reaction.The deficiency of zinc also leads to compromised T-cell mediated immune defence.Zinc also has anti-oxidant and anti-inflammatory properties, which can decrease apoptosis and transformation to a malignant state.
Thus, the present study intends to evaluate the role of oral zinc supplementation as an adjuvant to topical corticosteroid therapy on the treatment of oral lichen planus.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test group
The patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. Topical corticosteroid paste will be prescribed according to the intensity of the lesion.
Oral Zinc supplementation
In the test group, the patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. They will also be will be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.
Control group
The patients will be administered Placebo tablets for 6 weeks from the baseline. Topical corticosteroid paste will be prescribed according to the intensity of the lesion.
Oral placebo supplementation
In the control group, the patients will be administered Placebo tablets for 6 weeks from the baseline. They will also be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.
Interventions
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Oral Zinc supplementation
In the test group, the patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. They will also be will be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.
Oral placebo supplementation
In the control group, the patients will be administered Placebo tablets for 6 weeks from the baseline. They will also be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who are willing to participate in the study.
Exclusion Criteria
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.
ALL
Yes
Sponsors
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Postgraduate Institute of Dental Sciences Rohtak
OTHER
Responsible Party
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Principal Investigators
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Shagun Solanki
Role: PRINCIPAL_INVESTIGATOR
Post Graduate Institute of Dental Sciences, Rohtak
Locations
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Post Graduate Institute of Dental Sciences
Rohtak, Haryana, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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shagun257
Identifier Type: -
Identifier Source: org_study_id
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