Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease (BD)
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|ClinicalTrials.gov Identifier: NCT03771768|
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Behcet Syndrome||Radiation: Diode laser 980nm&100 mWatt Drug: Triamcinolone Acetonide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1|
|Masking:||Double (Care Provider, Investigator)|
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.
|Official Title:||Active Control,Randomized,Double- Blinded Clinical Trial of BD|
|Estimated Study Start Date :||May 25, 2019|
|Estimated Primary Completion Date :||May 25, 2019|
|Estimated Study Completion Date :||May 25, 2019|
Active Comparator: Triamcinolone acetonide
Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.
Drug: Triamcinolone Acetonide
0.1 &5gm paste 4 times/day
Other Name: Topical corticosteroid
Experimental: Diode laser
Diode laser 980 nm & 100mWatt.
Radiation: Diode laser 980nm&100 mWatt
Diode laser 980 nm &100 milli Watt.
- Oral ulcer activity index [ Time Frame: One month ]Composite index score (0-10)
- Oral health - related quality of life [ Time Frame: One month ]Oral health impact profile - 14 (OHIP- 14)
- Pain associated with oral ulcer [ Time Frame: One month ]Visual analogue scale (0-10)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771768
|Contact: Clair Sobhy Nagieb, MSC||01222259819 ext Cairo U||Clair.firstname.lastname@example.org|
|Contact: Zaki S.Zaki, MSCemail@example.com|
|Study Director:||Sherin Ali Hassan, MD||Cairo University|