Protocol summary

Summary
(1)Objective:Comparison of RANKL and OPG release in GCF during orthodontic movement with or without LLLT; (2) design: Randomized; (3) setting and conduct: just before exposure by laser , GCF samples were collected. Then, while in both sides canines were retracted by elastic retractor, one side exposed to GaAlAs laser which applied on three points of the canine root( coronal, mid and apical ) of buccal, palatal and on the distal side individually . Exposure time was 3 min on each oppoinment. The same procedure applied to the contralateral quadrant but without laser emission. Samples collected and sent to laboratory in ice- pack container for analysis of RANKL and OPG (4) Participant including criteria: public comment and were healthy periodontal, Crowding or protrusion with dental and orthodontic needs were, The right and left first premolar had been previously extracted;Participant exclusion criteria: Patient with particular systemic diseases; Patients under treatment with special medication; Smokers and patients consume alcohol; Patients that received systemic antibiotics during 6 month ago, plaque index < %40 (5) Intervention: Treatment with diod laser(6) main outcome measures: Rankl, OPG

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062228590N1
Registration date: 2016-07-16, 1395/04/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-16, 1395/04/26
Registrant information
Name
Mahmoud Soleimani
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4053
Email address
m.soleymani@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of RANKL and OPG release in GCF during orthodontic movement with or without Low Level Laser Therapy
Public title
Comparison of inflammatory mediators release in GCF during orthodontic movement with or without Low Level Laser Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: public comment and were healthy periodontal; Crowding or protrusion with dental and orthodontic needs were; The right and left first premolar had been previously extracted Exclusion criteria: Patient with particular systemic diseases; Patients under treatment with special medication; Smokers and patients consume alcohol; Patients that received systemic antibiotics during 6 month ago; plaque index < %40
Age
From 81 years old to 79 years old
Gender
Both
Phase
2-3
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

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
2016-05-17, 1395/02/28
Ethics committee reference number
IR.mui.rec.1395.4.22

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
RANKL
Timepoint
0,2,7,21 days
Method of measurement
Perticular kit of elisa

2

Description
OPG
Timepoint
0,2,7,21 days
Method of measurement
Perticular kit of elisa

Secondary outcomes

empty

Intervention groups

1

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

2

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Mahmoud Soleimani
Street address
Islamic Azad University of Isfahan(Khorasgan), Jey Street
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
Mahmoud Soleimani
Position
Periodontics/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
m.soleymani@khuisf.ac.ir; msoleimani2006@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
Mahmoud Soleimani
Position
Periodontics/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
m.soleymani@khuisf.ac.ir; msoleimani2006@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic azad university Isfahan (Khorasgan)
Full name of responsible person
Mahmoud Soleimani
Position
periodontics/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
m.soleymani@khuisf.ac.ir; msoleimani2006@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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