Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus
NCT ID: NCT02329600
Last Updated: 2016-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2013-06-30
2014-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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control subjects
10 systemically healthy control subjects taking no medication.
No interventions assigned to this group
OLP and corticosteroid
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.
Triamcinolone Acetonide
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
OLP and corticosteroid and green tea
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.
green tea tablets (Green tea extract 5:1) 200 mg
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.
Triamcinolone Acetonide
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
Interventions
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green tea tablets (Green tea extract 5:1) 200 mg
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.
Triamcinolone Acetonide
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Free of any visible oral lesions other than oral lichen planus
* Free of any systemic diseases
Exclusion Criteria
* Pregnant or breast feeding women
* Smokers
* Use of corticosteroids or other immunosuppressive drugs
30 Years
68 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Noha Ayman Ghallab
Associate Professor of periodontology and Oral Medicine, faculty of oral and dental medicine
Principal Investigators
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Noha Ghallab, M.D.
Role: STUDY_CHAIR
Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
Enji Ahmed, M.D.
Role: STUDY_DIRECTOR
Lecturer of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
Ghada Nabil, B.D.S
Role: PRINCIPAL_INVESTIGATOR
Instructor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
References
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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.
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.
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.
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.
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.
Other Identifiers
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polyphenol_TOC_OLP
Identifier Type: -
Identifier Source: org_study_id