objective: evaluation the effect of low energy laser irradiation on the rate of mandibular molar protraction. this study will be randomized, single blind and controlled with placebo. 28 young patients (14 male and 14 female) will be participated in this study. 1. All patients signed the informed contest to participate in this study. 2. all patients will have normal growth pattern. 3. Based on treatment plane, every patient need mandibular second premolar extraction on both sides. Patients with tooth missing, horizontal growth pattern and any previous second premolar extraction were excluded. mandibular first molar protraction will be done by T-loop on both sides, but one side will receive laser and other side placebo. laser irradiation will done on first time, after one month and second month. The amount of molar protraction will be evaluated by dental cast.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030921406N1
Registration date:2015-06-16, 1394/03/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-16, 1394/03/26
Registrant information
Name
Sepideh Rezapour Gavareshki
Name of organization / entity
Orthodontic Department of Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 9913
Email address
rezapour_s@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
orthodontic research center of shiraz dental school
Expected recruitment start date
2015-04-30, 1394/02/10
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation the effect of low energy laser irradiation on the rate of mandibular molar protraction in orthodontic patients
Public title
evaluation the effect of low energy laser on rate of tooth movement during orthodonthic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- all patients had the same vertical growth pattern-normal pattern- which was verified by evaluating Jaraback index and sum of Bjork on their lateral cephalometric images (Jaraback index 65-70 % and sum of Bjork 390˚-400˚). 2- There was no missing tooth in the lower arch. 3- Based on treatment plane, every patient need mandibular second premolar extraction on both sides to treat open bite dentally or correct molar relationship. 4- All patients signed the informed contest to participate in this study. Patients with tooth missing, horizontal growth pattern and any previous second premolar extraction were excluded.
Age
From 16 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
central building of Shiraz University of Medical Sciences, opposit of felestin ST, zand Blv
City
Shiraz
Postal code
14336 - 71348
Approval date
2011-02-06, 1389/11/17
Ethics committee reference number
T-P-89-2251
Health conditions studied
1
Description of health condition studied
Injury, poisoning and certain other consequences of external causes
ICD-10 code
S00-T98
ICD-10 code description
S00-S09
Primary outcomes
1
Description
amount of mandibular first molar movement
Timepoint
at the begining of study, at the end of first , second and third month
Method of measurement
milimeter measurement with gauge on dental cast
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: at first cession T-loop will be activated for first mandibular molar protraction. at same time irradiation will be done at mocusa of left first molar in mesiobuccal, mid buccal, disto buccal, mesio lingual, mid lingual, disto lingual and mesial of first molar. every point will be irradiated for 45 seconds. this will be repeat at the end of first and second month.
Category
Treatment - Devices
2
Description
control group: at first cession after T-loop activation on both side of patient, on left first molar we will put laser tip on the same points of right first molar but will not push the pedal. we will use the dark shield over the laser tip and the person who will activate loop will be different from person who push laser pedal. consequently first person will be blind to irradiation side. this will be done as well as laser side and will be repeated at the end of first and second month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Private orthodontic office
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Orthodontics research center
Full name of responsible person
Dr Hamodreza Pakshir, chief of Orthodontics research center
Street address
shiraz dental school,ghom abad Ave, ghasro dasht St
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Orthodontics research center
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
orthodontic department of shiraz dental school
Full name of responsible person
sepideh rezapour gavareshki
Position
post graduated student
Other areas of specialty/work
Street address
shiraz dental school, ghom abad Ave, ghasro dasht St
City
shiraz
Postal code
Phone
+98 71 3628 9913
Fax
Email
rezapour_s@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shiraz dental school
Full name of responsible person
Dr parisa salehi
Position
professor of orthonontic department
Other areas of specialty/work
Street address
shiraz dental school, ghom abad Ave, ghasro dasht St
City
shiraz
Postal code
Phone
+98 71 3628 9913
Fax
Email
salehipa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
orthodontic department of shiraz dental school
Full name of responsible person
sepideh rezapour gavareshki
Position
post graduated student
Other areas of specialty/work
Street address
City
shiraz
Postal code
Phone
+98 71 3628 9913
Fax
Email
rezapour_s@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)