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َ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

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History
# Registration date Revision Id
2 2018-05-23, 1397/03/02 48332
1 2018-03-25, 1397/01/05 40965
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  • General information

    No
    No
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    15
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    2018-03-30, 1397/01/10
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    2018-04-21, 1397/02/01

  • Sharing plan

    undecided
    yes
    undecided
    yes
    undecided
    no
    undecided
    no
    undecided
    no
    undecided
    na
    undecided
    na
    -
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    -
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    Data on the main consequences can be shared
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    داده های مربوط به پیامدهای اصلی امکان اشتراک گذاری دارد.
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    Start the access period from 1398
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    شروع دوره دسترسی از سال 1398
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    Researchers working in academic institutions
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    محققین شاغل در موسسات دانشگاهی
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    Data are available for international researchs
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    برای تحقیقات بین المللی داده ها قابل استفاده اند.
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    Visit urmia university of medical sciences
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    به دانشگاه علوم پزشکی ارومیه مراجعه گردد
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    The data can be accessed only from the oral health department of Urmia Dental School
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    داده ها فقط بصورت حضوری از بخش بیماری های دهان دانشکده دندانپزشکی ارومیه قابل دستیابی است

  • Trial results

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    The effect of pulsed CO2 laser and continuous CO2 laser on the severity of pain in oral aphthous lesions,compared the pain intensity before intervention with all post-intervention follow up hours,including immediately after treatment and 12,24,48 and 72 hours after intervention,statistically was meaningful.while at immediately and 72 h after treatment follow ups in the usual treatment group,pain relief was significantly different from the pretreatment;but this significantly different was not observed in other follow up hours.comparing the size of the ulcer on days 1,3,5 and 7 after treatment shows the difference was significant between the first and seventh day in pulsed laser group.this difference between the first,fifth and seventh day in countinuous laser group and the usual treatment group was significant.
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    تاثیر لیزر CO2 پالسی و لیزر CO2 پیوسته بر روی شدت درد ضایعات آفت دهانی،در مقایسه کاهش شدت درد قبل از مداخله با تمام ساعات پیگیری بعد از مداخله که شامل بلافاصله بعد از درمان و 12،24،48 و 72 ساعت بعد از مداخله میشد،معنی دار بود.در حالی که در گروه درمان معمول با تریامسینولون موضعی 0/1 % کاهش شدت درد نسبت به قبل از درمان،بین مقاطع پیگیری بلافاصله بعد از درمان و 72 ساعت بعد از درمان معنی دار و نسبت به سایر مقاطع مورد سنجش معنی دار نبود.در مقایسه اندازه زخم در روزهای 3،5 و 7 بعد از مداخله نسبت به روز اول ،این تفاوت در گروه لیزر CO2 پالسی بین روز اول و هفتم معنی دار بود. و در گروه لیزر CO2پیوسته و درمان معمول بین روز اول و پنجم و هفتم معنی دار بود.

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
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
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

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)
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
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