Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease

Study Overview
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Brief Summary
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Laser therapy is increasingly showing promising results in dental field including oral ulcers.This trial will assess the usefulness of Diode Laser compared to corticosteroid on oral ulcers of patients diagnosed with Behcet's disease.

Detailed Description
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The enrolled patients will be divided randomly into two groups.one group will receive Diode Laser (power:100 milli Watt,wavelength:980 mmm, delivery system:biostimulation probe) and other group will receive topical corticosteroids(Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermaphor) four times daily.

Official Title
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Active Control,Randomized,Double- Blinded Clinical Trial of BD

Conditions
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Autoimmune, Behcet Syndrome

Intervention / Treatment
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* Radiation: Diode laser 980nm&100 mWatt
* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed with Behcet's Disease according to International Criteria for BD. patients with active oral ulcers. patients free from any visible oral lesions other than the oral ulcers of BD. patients who agreed to take the supplied interventions. patients who will agree to participate in the study. patients who will accept to sign the informed consent. Exclusion Criteria: patients not physically able to participate in survey or clinical oral examination. patients with organ or life-threatening disease. patients with history of a severe or chronic medical condition including tuberculosis, hepatitis and human immunodeficiency virus. patients under immunosuppressive drugs. patients with organ transplantation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: 1:1
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triamcinolone acetonide<br>Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month. | Drug: Triamcinolone Acetonide<br>* 0.1 &5gm paste 4 times/day<br>* Other names: Topical corticosteroid;|
| Experimental: Diode laser<br>Diode laser 980 nm & 100mWatt. | Radiation: Diode laser 980nm&100 mWatt<br>* Diode laser 980 nm &100 milli Watt.<br>* Other names: Soft laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral ulcer activity index | Composite index score (0-10) | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health - related quality of life | Oral health impact profile - 14 (OHIP- 14) | One month | 
| Pain associated with oral ulcer | Visual analogue scale (0-10) | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral ulcers