Oral Lichen Planus
Conditions
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.
Interventions
DRUGgreen 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.
DRUGTriamcinolone 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 68 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | one month after treatment | pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Total Oxidative Capacity | one month after treatment | total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Subjects 10 systemically healthy control subjects taking no medication. | 10 |
| 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 | 15 |
| 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 | 15 |
| Total | 40 |
Baseline characteristics
| Characteristic | OLP and Corticosteroid | OLP and Corticosteroid and Green Tea | Control Subjects | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 10 Participants | 40 Participants |
| Age, Continuous | 41.4 years STANDARD_DEVIATION 9.7 | 44.3 years STANDARD_DEVIATION 16.2 | 27.6 years STANDARD_DEVIATION 2.7 | 38 years STANDARD_DEVIATION 15.3 |
| Region of Enrollment Egypt | 15 participants | 15 participants | 10 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 5 Participants | 24 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 10 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Pain
pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment
Time frame: one month after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Subjects | Pain | 0 units on a scale | Standard Deviation 0 |
| OLP and Corticosteroid | Pain | 4 units on a scale | Standard Deviation 2.4 |
| OLP and Corticosteroid and Green Tea | Pain | 4.4 units on a scale | Standard Deviation 2.1 |
Secondary
Salivary Total Oxidative Capacity
total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment
Time frame: one month after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Subjects | Salivary Total Oxidative Capacity | 6.37 umol/L | Standard Deviation 4.06 |
| OLP and Corticosteroid | Salivary Total Oxidative Capacity | 58.41 umol/L | Standard Deviation 16.3 |
| OLP and Corticosteroid and Green Tea | Salivary Total Oxidative Capacity | 23.27 umol/L | Standard Deviation 12.95 |