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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: IRCT
Last refreshed on: 16 July 2018
Main ID:  IRCT20180224038840N1
Date of registration: 2018-03-25
Prospective Registration: Yes
Primary sponsor: Oroumia University of Medical Sciences
Public title: The Effect of Carbon Dioxide Laser on The Treatment of Aphthous Stomatitis
Scientific title: ?A Comparsion Between Pulsed and Continuous CO2 Laser Effect in Recurrent Aphthous Stomatitis and Comparing its Effects with Common Treatment Local Triamcinolone 0.1% : A randomised clinical trial
Date of first enrolment: 2018-03-30
Target sample size: 15
Recruitment status: Complete
URL:  http://en.irct.ir/trial/29991
Study type:  interventional
Study design:  Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Computerized with Concealed Randomization Sequence Carried Out at an External site.  
Phase:  N/A
Countries of recruitment
Iran (Islamic Republic of)
Contacts
Name: Seyyed Amir Seyyedi   
Address:  Alborz Dental Clinic,Alborz Ave,Urmia Town 5756115111 Urmia Iran (Islamic Republic of)
Telephone: +98 44 3336 3600
Email: seyyediamir@yahoo.com
Affiliation:  Oroumia University of Medical Sciences
Name: Sanaz Partovi   
Address:  Alborz Dental Clinic,Alborz Ave,Urmia Town 5756115111 Urmia Iran (Islamic Republic of)
Telephone: +98 44 3336 3600
Email: dr.partovi71925@yahoo.com
Affiliation:  Oroumia University of Medical Sciences
Key inclusion & exclusion criteria
Inclusion criteria: A Reliable History of Minor RAS
Enrollment of the Patient into the Study Within 3 Days or Less of the Appearance of the Ulcers
The Presence of one or more Discrete Minor Aphthous Ulcers

Exclusion criteria: Pregnancy
Age Less Than 12 Years
Any Known Systemic Disease That Could Predispose the Patient to RAS
Treatment of Their Current Ulcers with Any Form of Topical Medications
History of Receiving Any Systemic Treatment Known to Have Any Effect on RAS Within the Previous 3 Months


Age minimum: 12 years
Age maximum: no limit
Gender: Both
Health Condition(s) or Problem(s) studied
Recurrent Aphthous Stomatitis.
Recurrent oral aphthae
Intervention(s)
Intervention 1: Intervention group: Pulsative CO2 Laser(Ultra Dream Daeshine Enterprise;model:DS40U) ,261 Wat Power,Puls Duration:180 Microsecond,Puls Repeat Time:40 ms. Intervention 2: Intervention group: Putting a Layer of the Transparent gel and Useing Continuous CO2 Laser with 1 Wat Power,Radiation Time:5-10 Second,Spiral Radiation. Intervention 3: Intervention group: Topical Triamcinolone Acetonide 0.1% Ointment , Raha Pharmaceutical Company, 3 times a day.
Primary Outcome(s)
Size of the Ulcer. Timepoint: 1 , 3 , 5 and 7 Day After Intervention. Method of measurement: Millimeter.
Ulcer Pain and Severity. Timepoint: Before Intervention,Immediately After Intervention,12,24,48 and 72 h After Intervention. Method of measurement: (VAS) Visual Analogue Scale.
Healing Time. Timepoint: 1,3,5 and 7 Day After Intervention. Method of measurement: Day.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Oroumia University of Medical Sciences
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Urmia University of Medical Sciences
Results
Results available: Yes
Date Posted:
Date Completed:
URL:
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