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

Phase 4

Completed

• Conditions: Oral Lichen Planus
• Interventions: Drug: Topical pomegranate seeds and peel extracts

• Registration Number: NCT04193748
• Lead Sponsor: Cairo University

Brief Summary

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

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).

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2019-11-20
• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2019-12-08
• Study First Posted: 2019-12-10
• Study Completion: 2019-12-13
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	Topical pomegranate seeds and peel extracts	Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks.
Group P	Topical pomegranate seeds and peel extracts	Topical pomegranate peel extract treatment has been repeated four times per day for four weeks.
Control group	Topical pomegranate seeds and peel extracts	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.

Primary Outcome Measures

Name	Time	Method
visual analog scale (VAS)	4 weeks	Pain assessment scale

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Oral Medicine and Periodontology Department; 🇪🇬 Cairo, Egypt

Faculty of Dentistry, Cairo University; 🇪🇬 Giza, Egypt