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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone acetonide | Active Comparator | Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month. |
|
| Diode laser | Experimental | Diode laser 980 nm & 100mWatt. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diode laser 980nm&100 mWatt | Radiation | Diode laser 980 nm &100 milli Watt. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral ulcer activity index | Composite index score (0-10) | One month |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clair Sobhy Nagieb, MSC | Contact | 01222259819 | Cairo U | Clair.nadieb@dentistry.cu.edu.eg |
| Zaki S.Zaki, MSC | Contact | 01224045116 | drzaki95@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Sherin Ali Hassan, MD | Cairo University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23622766 | Background | Prasad R S, Pai A. Assessment of immediate pain relief with laser treatment in recurrent aphthous stomatitis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Aug;116(2):189-93. doi: 10.1016/j.oooo.2013.02.011. Epub 2013 Apr 23. | |
| 24488418 | Background | Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, Yazici H. Outcome measures used in clinical trials for Behcet syndrome: a systematic review. J Rheumatol. 2014 Mar;41(3):599-612. doi: 10.3899/jrheum.131249. Epub 2014 Feb 1. |
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| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| D019226 | Oral Ulcer |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D014222 | Triamcinolone Acetonide |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D014221 | Triamcinolone |
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1:1
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Double - blinded trial:
Outcome assessor (CS) and Statistician. Participants couldn't be blinded because of the difference in the nature of interventions method of application.
| Triamcinolone Acetonide | Drug | 0.1 &5gm paste 4 times/day |
|
|
| One month |
| 34212234 | Derived | Nagieb CS, Harhash TA, Fayed HL, Ali S. Evaluation of diode laser versus topical corticosteroid in management of Behcet's disease-associated oral ulcers: a randomized clinical trial. Clin Oral Investig. 2022 Jan;26(1):697-704. doi: 10.1007/s00784-021-04047-8. Epub 2021 Jul 2. |
| D014605 |
| Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| D011245 |
| Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |