Protocol summary

Summary
Objective: The effect of low laser therapy on gingival crevicular fluid (GCF) level of IL-6 and IL-8 during orthodontic treatment; design: Randomized. Setting and conduct: After compilation of SRP the orthodontic treatments will be started. Low Level laser irradiation will be done in 0,2,7, 21 days and GCF will be collected with paper cone in distal sulcus of canine. Then all of the samples will be transfered to laboratory. Inclusion criteria: patients with healthy general conditionand and healthy periodontal tissue, patients with crowding or protrusion, that they need fix orthodontic treatment. Exclusion criteria: Patients with particular systemic diseases; Patients under treatment with special medication; Smokers and patients consume alcohol; Patients that received systemic antibiotics during the past six month, plaque index < %40. Intervention: Treatment with diod laser. main outcome measures: IL-6, IL-8

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071328914N1
Registration date: 2016-08-08, 1395/05/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-08, 1395/05/18
Registrant information
Name
Farid Mohammadi
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4053
Email address
farid.mohammadi@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low laser therapy on gingival crevicular fluid (GCF) level of IL-6 and IL-8 during orthodontic treatment
Public title
The effect of low laser therapy on gingival crevicular fluid (GCF) level of inflammation mediators during orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with healthy general condition and healthy periodontal tissue; patients with crowding or protrusion that need fix orthodontic treatment. Exclusion criteria: Patients with systemic diseases; Patients under treatment with special medication; Smokers and patients consume alcohol; Patients that received systemic antibiotics during the past six months; plaque index < %40
Age
From 82 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
simple random

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Islamic Azad University of Isfahan (Khorasgan), Dental School
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Approval date
2016-04-12, 1395/01/24
Ethics committee reference number
IR.mui.rec.1395.4.11

Health conditions studied

1

Description of health condition studied
tooth movement
ICD-10 code
Z01.2
ICD-10 code description
Dental examination

Primary outcomes

1

Description
IL-6
Timepoint
2,4, 9, 23 days
Method of measurement
Perticular kit of elisa

2

Description
IL-8
Timepoint
2,4, 9, 23 days
Method of measurement
Perticular kit of elisa

Secondary outcomes

empty

Intervention groups

1

Description
control: no Laser, orthodontics therapy
Category
Treatment - Other

2

Description
Intervention: laser therapy, orthodontics treatment
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dept. of Periodontics, Islamic Azad Dental School Khorasgan Branch, Isfahan, Iran
Full name of responsible person
Farid Mohammadi
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Islamic Azad University Isfahan (Khorasgan)
Full name of responsible person
Dr Vahid Esfahanian
Street address
Islamic Azad University of Isfahan (Khorasgan), Dental School
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Islamic Azad University Isfahan (Khorasgan)
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
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Farid Mohammadi
Position
phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4053
Fax
Email
farid.mohammadi@khuisf.ac.ir; faridbn2000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Farid Mohammadi
Position
phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4053
Fax
Email
farid.mohammadi@khuisf.ac.ir; faridbn2000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Farid Mohammadi
Position
phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4053
Fax
Email
farid.mohammadi@khuisf.ac.ir; faridbn2000@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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