َ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
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:2018-03-25, 1397/01/05
Update count:1
Registration date
2018-03-25, 1397/01/05
Registrant information
Name
Seyyed Amir Seyyedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3322 4288
Email address
seyedi.a@umsu.ac.ir
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
empty
Actual recruitment end date
empty
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
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Alborz Dental Clinic,Alborz Ave.,Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
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
Secondary outcomes
empty
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Depatment of Oral Medicine,Urmia Dental Shool
Full name of responsible person
Sanaz Partovi
Street address
Alborz Dental Clinic,Alborz Ave,Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3336 3600
Email
dr.partovi71925@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Seyyed Amir Seyyedi
Street address
Alborz Dental Cilinic,Alborz Ave,Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3336 3600
Email
seyyediamir@yahoo.com
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
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sanaz Partovi
Position
Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Alborz Dental Clinic,Alborz Ave,Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3336 3600
Email
dr.partovi71925@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Seyyed Amir Seyyedi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Alborz Dental Clinic,Alborz Ave,Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3336 3600
Email
seyyediamir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sanaz Partovi
Position
Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Alborz Dental Clinic,Alborz Ave,Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3336 3600
Email
dr.partovi71925@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available