Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus

Phase 3

Completed

• Conditions: Oral Lichen Planus
• Interventions: Drug: Triamcinolone Acetonide

• Registration Number: NCT02329600
• Lead Sponsor: Cairo University

Brief Summary

The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.

Detailed Description

This study included forty individuals divided into 3 groups. Group A; 10 systemically healthy control subjects not receiving medication.

Group B; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.

Group C; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-08
• Study Completion: 2014-10
• Study First Submitted: 2014-12-29
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2014-12-31
• Results First Submitted: 2016-07-28
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-25
• Last Update Submitted: 2016-09-25
• Results First Posted: 2016-11-15
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients presented with painful oral lichen planus lesions
• Free of any visible oral lesions other than oral lichen planus
• Free of any systemic diseases

Exclusion Criteria

• Topical treatment or systemic therapy of OLP for one month before starting the study
• Pregnant or breast feeding women
• Smokers
• Use of corticosteroids or other immunosuppressive drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OLP and corticosteroid	Triamcinolone Acetonide	15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
OLP and corticosteroid and green tea	Triamcinolone Acetonide	15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.

Primary Outcome Measures

Name	Time	Method
Pain	one month after treatment	pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment

Secondary Outcome Measures

Name	Time	Method
Salivary Total Oxidative Capacity	one month after treatment	total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment