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evaluation the effect of low level and high level laser therapy on recurrent aphthous stomatitis and comparison of their effects together

Protocol summary

Summary
There are limited number of studies about the laser effect on aphthous ulcers,so we want to assess the effect of low and high level laser therapy on the severity of pain, pain duration and the duration of tissue repair in aphthous ulcers. Iin this study 30 patients with at least 1 minor aphthous stomatitis not longer than 72 hours from their incidence will be evaluated. Pregnant and breast feeder women, patients with severe heart, liver and renal problems, patients undergone local and systemic therapy with corticosteroids and antibiotics in the previous month will be excluded.Patients will be divided into 3 groups randomly.one group will be treated with low level laser(4min, 25mW, 670nm, Azor laser), the second group with high level laser(10-5s, 2W,10600nm, CO2laser) and the last one with the laser hand-piece on the off mode as the placebo treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012120911702N1
Registration date: 2013-02-04, 1391/11/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-02-04, 1391/11/16
Registrant information
Name
Nasim Zeini Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1630 4539
Email address
zeinin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation the effect of low level and high level laser therapy on recurrent aphthous stomatitis and comparison of their effects together
Public title
evaluation of laser effect on recurrent aphthous ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with at least 1 minor aphthous stomatitis; not longer than 72 hours from the incidence of the lesion Exclusion criteria: Pregnant and breast feeder women; patients with severe heart, liver and renal problems; patients undergone local and systemic therapy with corticosteroids and antibiotics in the previous month
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
Approval date
2012-09-13, 1391/06/23
Ethics committee reference number
CT-91-4105

Health conditions studied

1

Description of health condition studied
recurrent aphthous stomatitis
ICD-10 code
k12.0
ICD-10 code description
K12.0 Recurrent oral aphthae

Primary outcomes

1

Description
severity of pain
Timepoint
every day up to 10 days
Method of measurement
visual analogue scale

Secondary outcomes

1

Description
duration of ulcers
Timepoint
every day up to 10 days
Method of measurement
questionaire

Intervention groups

1

Description
low level laser therapy: Azor laser, 670nm, 25mW, 4min
Category
Treatment - Other

2

Description
high level laser therapy: CO2 laser, 10600nm, 2W, 5-10s
Category
Treatment - Other

3

Description
placebo treatment: the low level laser hand-piece on the off mode, 4min
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Nasim Zeini Jahromi
Street address
Ghasrodasht
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Pustforosh
Street address
Zand st.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasim Zeini Jahromi
Position
student
Other areas of specialty/work
Street address
Shiraz Dental School
City
Shiraz
Postal code
Phone
+98 71 1628 9917
Fax
Email
nasim.zeini@yahoo.comnasim.zeini.85@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Nasim Zeini Jahromi
Position
post graduate student
Other areas of specialty/work
Street address
Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71 1628 9917
Fax
Email
nasim.zeini@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Nasim Zeini Jahromi
Position
student
Other areas of specialty/work
Street address
Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71 1628 9917
Fax
Email
nasim.zeini@yahoo.comnasim.zeini.85@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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