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Effects of diode laser (980 nm) on orthodontic tooth movement

Protocol summary

Summary
The aim of this study is to evaluate the effects of low-level laser therapy on the velocity of orthodontic tooth movement (OTM) and the interleukin-6(IL-6) concentration in gingival crevicular fluid (GCF) during orthodontic treatment. In this randomized double blind clinical trial, 11 female patients who need first premolar extraction and canine retraction will be selected. The GaAlAs laser (diode laser, 980 nm, 100 mW, 5.6 J/cm2, 6 points, 56 seconds, and continuous mode) will be used in the canine retraction phase in one quadrant (LG). The other quadrant is considered as the control group (CG). The laser will be applied on day 0,7th, 14th, 21st, 28th days each month during canine retraction phase. Dental casts will be made at different time points during the treatment and the amount of tooth movement will be measured. GCF samples will be obtained from the distal side of maxillary canine teeth on both sides at the beginning of the trial, the end of aligning phase and at the 21st days of each month during canine retraction, to evaluate the levels of IL-6.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015100324324N1
Registration date: 2016-01-25, 1394/11/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Farzaneh Eslami
Name of organization / entity
Shahid Sadoughi university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 5775
Email address
farzaneheslami@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahid sadoughi university of medical science
Expected recruitment start date
2014-04-05, 1393/01/16
Expected recruitment end date
2014-07-17, 1393/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of diode laser (980 nm) on orthodontic tooth movement
Public title
Effects of laser on tooth movement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with bimaxillary dentoalveolar protrusion who need first premolar extraction and canine retraction; no systemic disease; no previous permanent teeth extraction; not being under medical treatment that could interfere with bone metabolism such as NSAIDS or doxycycline; a good level of oral hygiene; no periodontal disease or radiographic evidence of bone loss, 7- no pregnancy during treatment; signing the informed consent by the patient or her parents Exclusion criteria: lack of patient interest; inappropriate oral hygiene; prolonged drug consumption during treatment; not coming for their appointment; repeated bracket debonds
Age
From 14 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 11
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
the selection of the laser and control group was randomly done, according to the flipping a coin.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahid sadoughi university of medical science
Street address
shahid bahonar squre, Yazd
City
Yazd
Postal code
Approval date
2014-05-11, 1393/02/21
Ethics committee reference number
17/1/31871

Health conditions studied

1

Description of health condition studied
orthodontic tooth movement
ICD-10 code
z51.8
ICD-10 code description
Other specified medical care

Primary outcomes

1

Description
accelerating tooth movement
Timepoint
4 times oer month
Method of measurement
from dental cast

2

Description
interluekin6
Timepoint
1 time per month
Method of measurement
sampling from gingival crevicular fluid

Secondary outcomes

empty

Intervention groups

1

Description
in laser group, the diode laser is used to accelerate tooth movement
Category
Treatment - Other

2

Description
in control group ,laser is not used.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Farzaneh Eslami
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research vice chancellor of Shahid Sadoughi University of Medical Science
Full name of responsible person
dr.Mmehrparvar
Street address
shahid bahonar square, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellor of Shahid Sadoughi University of Medical Science
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
Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Farzaneh Eslami
Position
orthodontic resident
Other areas of specialty/work
Street address
Department of Orthodontics, Faculty of Dentistry, Daheye Fajr BLV,Yazd
City
Yazd
Postal code
Phone
+98 35 3621 2222
Fax
Email
farzaneh.eslami@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Farzaneh Eslami
Position
orthodontic resident
Other areas of specialty/work
Street address
Department of Orthodontics, Faculty of Dentistry, Daheye Fajr BLV,Yazd
City
Yazd
Postal code
Phone
+98 35 3621 2222
Fax
Email
farzaneh.eslami@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Dentistry, Shahid Sadoughi university of medical science
Full name of responsible person
Farzaneh Eslami
Position
Orthodontic resident
Other areas of specialty/work
Street address
Department of Orthodontics, Faculty of Dentistry, Daheye Fajr BLV,Yazd
City
Yazd
Postal code
Phone
+98 35 3621 2222
Fax
Email
farzaneh.eslami@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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