Protocol summary
-
Study aim
-
A Comparsion Between Pulsed and Continuous CO2 Laser Effect in Recurrent Aphthous Stomatitis and Comparing its Effect with Common Treatment Local Triamcinolone 0.1%
-
Design
-
Two Arm,Parallel,Not Blinded Trial(Postoperative Care and Outcome Assessment).Randomization Was Computerized with Concealed Randomization Sequence Carried Out at an External site.
-
Settings and conduct
-
People with Inclusion criteria Who Refer to Urmia University Dental Public Health Ward,Enter to Study After Giving Informed Consent.
-
Participants/Inclusion and 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 Know 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
-
Intervention groups
-
1)Pulsative CO2 Laser(Ultra Dream Daeshine Enterprise:model:DS40U),261 Wat Power,Puls Duration:180 Microsecond,Puls Repeat Time:40 ms
2)Putting a Layer of the Transparent Gel and Useing Continuous CO2 Laser with 1 Wat Power,Radiation Time:5-10 Second,Spiral Radiation
3)Topical Triamcinolone Acetonaide 0.1% Ointment ,Raha Pharmaceutical Company,3 Times a D;ay
-
Main outcome variables
-
Ulcer Pain and Severity;Healing Time;Size of the Ulcer
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20180224038840N1
Registration date:
2018-03-25, 1397/01/05
Registration timing:
prospective
Last update:
2018-06-07, 1397/03/17
Update count:
1
-
Registration date
-
2018-03-25, 1397/01/05
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-03-30, 1397/01/10
-
Expected recruitment end date
-
2018-04-30, 1397/02/10
-
Actual recruitment start date
-
2018-03-30, 1397/01/10
-
Actual recruitment end date
-
2018-04-21, 1397/02/01
-
Trial completion date
-
empty
-
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
-
Public title
-
The Effect of Carbon Dioxide Laser on The Treatment of Aphthous Stomatitis
-
Purpose
-
Treatment
-
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
-
From 12 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
15
Actual sample size reached:
15
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Computerized with Concealed Randomization Sequence Carried Out at an External site.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-02-09, 1396/11/20
-
Ethics committee reference number
-
IR.UMSU.Rec.1396.364
Health conditions studied
1
-
Description of health condition studied
-
Recurrent Aphthous Stomatitis
-
ICD-10 code
-
K12.0
-
ICD-10 code description
-
Recurrent oral aphthae
Primary outcomes
1
-
Description
-
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
2
-
Description
-
Healing Time
-
Timepoint
-
1,3,5 and 7 Day After Intervention
-
Method of measurement
-
Day
3
-
Description
-
Size of the Ulcer
-
Timepoint
-
1 , 3 , 5 and 7 Day After Intervention
-
Method of measurement
-
Millimeter
Intervention groups
1
-
Description
-
Intervention group: Pulsative CO2 Laser(Ultra Dream Daeshine Enterprise;model:DS40U) ,261 Wat Power,Puls Duration:180 Microsecond,Puls Repeat Time:40 ms
-
Category
-
Treatment - Other
2
-
Description
-
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
-
Category
-
Treatment - Other
3
-
Description
-
Intervention group: Topical Triamcinolone Acetonide 0.1% Ointment , Raha Pharmaceutical Company, 3 times a day
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Oroumia University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
Data on the main consequences can be shared
-
When the data will become available and for how long
-
Start the access period from 1398
-
To whom data/document is available
-
Researchers working in academic institutions
-
Under which criteria data/document could be used
-
Data are available for international researchs
-
From where data/document is obtainable
-
Visit urmia university of medical sciences
-
What processes are involved for a request to access data/document
-
The data can be accessed only from the oral health department of Urmia Dental School
-
Comments
-