Main
|
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: |
|
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.
|
Source(s) of Monetary Support
|
Oroumia University of Medical Sciences
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Urmia University of Medical Sciences
|
Results
|
Results available:
|
Yes |
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|