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Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus

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ClinicalTrials.gov Identifier: NCT03415165
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Esraa Magdy, Cairo University

Study Description
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Brief Summary:
Is topical application of green tea polyphenols buccal tablet more effective in treatment of patients with symptomatic oral lichen planus in comparison with topical application of corticosteroids and what is the most effective concentration of polyphenols

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: green tea buccal tablet Drug: Corticosteroids Topical Early Phase 1

Detailed Description:
  • Each patient was informed about the detailed procedure, and educated about benefits of the treatment, the known side effects and follow-up appointments needed. After that, each subject participating in the study signed an informed written consent form.
  • Subjects were given freedom to leave the study at any time when they need to. Group A (Experimental group) 200 mg green tea

Where patients in this group will receive a buccal tablet containing 200 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.

Preparation of buccal tablets : Mucoahesive buccal tablets is prepared by a direct compression procedure. Various batches are prepared by varying the chitosan:drug ratio to identify the most effective formulation. The mucoadhesive drug/polymer mixture is prepared by homogeneous mixing of the drug with chitosan , secondary polymer, and D-mannitol, in a glass mortar for 15 min. Then, Mg stearate will be added and mixed for 5 min .The mixture is compressed using a tablet machine (Type EK: O.Erweka apparatus, Frankfurt, Germany) using flat-tip punches and dies with 8-mm-diameter. Each tablet weighed 212 mg with a thickness of 3.1 mm.( Darwish and Elmeshad,2009)

Group B (Experimental group) 300 mg green tea

Where patients in this group will receive a buccal tablet containing 300 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.

Group C (Control group) corticosteroid group:

Where patients are treated with topical corticosteroids 1 mg/g Triamcinolone acetonide (Kenacort-A orabase 20 G Pomad: Deva dermatological product,Turkey) applied topically 4 times a day i.e. following each meal and at bed time for four weeks .


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of 200mg and 300mg Concentrates of Green Tea Polyphenols Using Buccal Tablets Versus Topical Application of Corticosteroids in Treatment of Patients With Symptomic Oral Lichen Planus Randomized Clinical Trial
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: green tea buccal tablet
buccal tablet 3 times aday
 Drug: green tea buccal tablet
buccal tablet for 8 hrs 3 times aday
Other Name: catechines
Sham Comparator: corticosteroids topical
topical steroids 3 times aday
 Drug: Corticosteroids Topical
kenacort in orabase 4 times aday
Other Name: local corticosteroids


Outcome Measures
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Primary Outcome Measures :
  1. size of the lesion [ Time Frame: 12 weeks ]
    the shape and the measurement of its size


Secondary Outcome Measures :
  1. visual analogue score [ Time Frame: 12 weeks ]
    pain score from 0 to 10


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic lesions.
  • OLP lesions with the diagnosis confirmed both clinically and histopathologically.
  • Clinical score higher than 3.
  • Disease duration of more than 2 months.
  • Absence of dysplasia in histological section

Exclusion Criteria:

  • Presence of any visible oral lesion other than OLP.
  • Pregnant or breast-feeding women,
  • Immuno-deficiency diseases.
  • Current malignancy or malignancy in history.
  • Concomitant treatment potentially effective on OLP within the previous 2 months such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs.
  • Severe or recurrent infections.
  • Lichenoid reaction.
  • Patients presents with skin lesions which may require systemic corticosteroid therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415165


Contacts
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Contact: EMagdy baligh, master 01003329610 esraa_magdy@dentistry.cu.edu.eg
Contact: esraa baligh, master 01003329610 esraa_magdy@dentistry.cu.edu.eg

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt, 00202
Contact: cairo university       ethics@dentistry.cu.edu.eg   
Contact: cairo university         
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: cairo university cu
More Information
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Responsible Party: Esraa Magdy, princible investigator EMagdy, Cairo University
ClinicalTrials.gov Identifier: NCT03415165     History of Changes
Other Study ID Numbers: 161187
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
 Skin Diseases
Mouth Diseases
Stomatognathic Diseases