- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03415165
Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: EMagdy baligh, master
- Phone Number: 01003329610
- Email: esraa_magdy@dentistry.cu.edu.eg
Study Contact Backup
- Name: esraa baligh, master
- Phone Number: 01003329610
- Email: esraa_magdy@dentistry.cu.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 00202
- Recruiting
- Cairo University
-
Contact:
- cairo university
- Email: ethics@dentistry.cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: green tea buccal tablet
buccal tablet 3 times aday
|
buccal tablet for 8 hrs 3 times aday
Other Names:
|
Sham Comparator: corticosteroids topical
topical steroids 3 times aday
|
kenacort in orabase 4 times aday
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
size of the lesion
Time Frame: 12 weeks
|
the shape and the measurement of its size
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analogue score
Time Frame: 12 weeks
|
pain score from 0 to 10
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: cairo university, CU
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 161187
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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