Clinical trial NCT02329600: Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus
Official title: Evaluation of Systemic Administration of Green Tea Polyphenols as a Supportive Antioxidant Agent in the Management of Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Lichen Planus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: one month after treatment
Secondary outcomes:
measure: Salivary Total Oxidative Capacity
timeFrame: one month after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
name: Noha Ghallab, M.D.
role: STUDY_CHAIR
affiliation: Lecturer of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
name: Enji Ahmed, M.D.
role: STUDY_DIRECTOR
affiliation: Instructor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
name: Ghada Nabil, B.D.S
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.