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

Phase 4CompletedNCT04193748

Cairo University42 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Oral Lichen Planus

Interventions

Topical pomegranate seeds and peel extractsDRUG

Topical pomegranate seeds and peel extracts in the form of gel

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Oral Medicine and Periodontology Department

Cairo, Egypt

Faculty of Dentistry, Cairo University

Giza, Egypt

Outcomes

Primary Outcomes

visual analog scale (VAS)

Pain assessment scale

Time frame: 4 weeks

Secondary Outcomes

Sign score

Score for clinical improvement of the signs

Time frame: 4 weeks

OHIP-14 questionnaire

evaluate the oral health related quality of life

Time frame: 4 weeks

Data from ClinicalTrials.gov

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