Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)

Overview

This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: November 20, 2019

Detailed Description

Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are numerous and include topical and systemic agents. Steroids were found effective in management of OLP with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. Pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. The recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of OLP decreasing pain and discomfort associated with this chronic condition.The aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (OLP).

Interventions

  • Drug: Topical pomegranate seeds and peel extracts
    • Topical pomegranate seeds and peel extracts in the form of gel

Arms, Groups and Cohorts

  • Active Comparator: Control group
    • Topical triamcinolone acetonide 0.1% available commercially (Kenacort- in orabase) has been used. Topical corticosteroid treatment has be repeated four times per day for four weeks.
  • Experimental: Group S
    • Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks.
  • Experimental: Group P
    • Topical pomegranate peel extract treatment has been repeated four times per day for four weeks.

Clinical Trial Outcome Measures

Primary Measures

  • visual analog scale (VAS)
    • Time Frame: 4 weeks
    • Pain assessment scale

Secondary Measures

  • Sign score
    • Time Frame: 4 weeks
    • Score for clinical improvement of the signs
  • OHIP-14 questionnaire
    • Time Frame: 4 weeks
    • evaluate the oral health related quality of life

Participating in This Clinical Trial

Inclusion Criteria

  • The study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type OLP and signed the informed consent Exclusion Criteria:

  • Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mai Zakaria Ibrahium Mohammed, Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt – Cairo University

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