Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus

Study Overview
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Brief Summary
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this study evaluates the effect of diode laser in treatment of oral lichen planus.

Detailed Description
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44 patients with erosive oral lichen planus were included in the study and divided into 2 equal groups. Group I received topical steroid therapy three times daily for 4 weeks and antifungal oral gel once daily for 1 week. Group II received 980nm Diode Laser 300 mW, up to 10 sessions.

Official Title
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Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)

Conditions
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Erosive Oral Lichen Planus

Intervention / Treatment
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* Device: 980nm Diode Laser
* Drug: 0.1% topical triamcinolone Acetonide preparation Kenacourt-A Orabase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient histologically diagnosed with erosive OLP based on WHO modified criteria 2003. Presence of painful erosive OLP lesions diagnosed by biopsy Exclusion Criteria: Pregnant or breast-feeding women Patients currently treated for cancer with Chemotherapy or Radiotherapy Patient currently on Corticosteroid therapy or had this treatment on the past 3 months Those who had used Anti-inflammatory drugs topical or systemic in the last month the use of drugs related to Oral Lichenoid Lesions Presence of Amalgam restorations near the OLP lesions dysplasia in histopathological examination uncontrolled systemic diseases physical or mental abnormality which would interfere with or be affected by the study procedure Patients with skin lesion

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kenacourt-A Orabase<br>the patients in this group received steroid therapy Kenacourt-A Orabase three times daily for 4 weeks. antifungal drug miconazole oral gel once daily for 1 week | Drug: 0.1% topical triamcinolone Acetonide preparation Kenacourt-A Orabase<br>* three times daily for 4 weeks<br>* Other names: Kenacourt-A Orabase;|
| Active Comparator: 980nm Diode Laser<br>the patients received 980 nm diode laser treatment 300 mW, non-contact mode up to 10 sessions | Device: 980nm Diode Laser<br>* 300 mW, 4 J/cm2, 2mm non-contact mode up to 10 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of pain from the base line to 12 weeks follow-up | Vas is one way to express pain into a numerical value where 0 means no pain and 10 means worst pain ever | base line, 6weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of clinical score of the lesion from the base line to 12 weeks follow-up | The size of the lesion is monitored where score 0 no lesions, score 1 : mild white striation only, score 2 : white striation with erythematous area < 1 cm 2, score 3 : white striation with erythematous area > 1 cm 2, score 4 : white striation < 1 cm2, score 5 : white striation with erosive area > 1 cm2. | base line, 6weeks and 12 weeks |