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

NCT02329600 | Completed Phase 3 Results

• 1 other identifier: polyphenol_TOC_OLP
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• Pain

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

  one month after treatment

Secondary Outcomes (1)

• Salivary Total Oxidative Capacity

  one month after treatment

Study Arms (3)

control subjects

NO INTERVENTION

10 systemically healthy control subjects taking no medication.

OLP and corticosteroid

ACTIVE COMPARATOR

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.

Drug: Triamcinolone Acetonide

OLP and corticosteroid and green tea

EXPERIMENTAL

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.

Drug: green tea tablets (Green tea extract 5:1) 200 mg; Drug: Triamcinolone Acetonide

Interventions

green tea tablets (Green tea extract 5:1) 200 mg DRUG

Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.

Also known as: Green Tea Polyphenolic Fraction

OLP and corticosteroid and green tea

Triamcinolone Acetonide DRUG

topical corticosteroids (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

Also known as: Kenalog in orabase

OLP and corticosteroid; OLP and corticosteroid and green tea

Eligibility Criteria

• Age: 30 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (5)

• Agha-Hosseini F, Mirzaii-Dizgah I, Farmanbar N, Abdollahi M. Oxidative stress status and DNA damage in saliva of human subjects with oral lichen planus and oral squamous cell carcinoma. J Oral Pathol Med. 2012 Nov;41(10):736-40. doi: 10.1111/j.1600-0714.2012.01172.x. Epub 2012 May 15.

  PMID: 22582895 RESULT

• Nakagawa T, Yokozawa T. Direct scavenging of nitric oxide and superoxide by green tea. Food Chem Toxicol. 2002 Dec;40(12):1745-50. doi: 10.1016/s0278-6915(02)00169-2.

  PMID: 12419687 RESULT

• Sander CS, Cooper SM, Ali I, Dean D, Thiele JJ, Wojnarowska F. Decreased antioxidant enzyme expression and increased oxidative damage in erosive lichen planus of the vulva. BJOG. 2005 Nov;112(11):1572-5. doi: 10.1111/j.1471-0528.2005.00743.x.

  PMID: 16225582 RESULT

• Singh BN, Shankar S, Srivastava RK. Green tea catechin, epigallocatechin-3-gallate (EGCG): mechanisms, perspectives and clinical applications. Biochem Pharmacol. 2011 Dec 15;82(12):1807-21. doi: 10.1016/j.bcp.2011.07.093. Epub 2011 Jul 30.

  PMID: 21827739 RESULT

• Zhang J, Zhou G. Green tea consumption: an alternative approach to managing oral lichen planus. Inflamm Res. 2012 Jun;61(6):535-9. doi: 10.1007/s00011-012-0440-z. Epub 2012 Feb 10.

  PMID: 22322481 RESULT

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Tea; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Noha Ayman Ghallab
• Organization: Faculty of Oral and Dental Medicine Cairo University

noha.ghallab@dentistry.cu.edu.eg

+201005263365

Study Officials

• Noha Ghallab, M.D.

  Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.

  STUDY CHAIR

• Enji Ahmed, M.D.

  Lecturer of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.

  STUDY DIRECTOR

• Ghada Nabil, B.D.S

  Instructor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of periodontology and Oral Medicine, faculty of oral and dental medicine

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: December 31, 2014
• Study Start: June 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 15, 2016
• Results First Posted: November 15, 2016

Record last verified: 2016-09