To assess the effect of corticotomy with and without lasercision on the canine retraction in orthodontic patients
Design
This is a randomized clinical trial, phase II, in which 12 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible orthodontic patients who will refer to School of Dentistry in Hamadan City during the study period will be enrolled in the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 15 to 30 years
Corticotomy of maxilla
Pulling bilateral premolars
Proper oral hygiene
Adequate thickness of adhesive gums (1 to 2 mm)
Exclusion criteria:
Active periodontitis
Probe depth of above 3 mm
A previous history of orthodontic
Any systematic disease
Vitamin D deficiency
Using NSAIDS drugs or hormonal supplements or tricyclic antidepressants
Intervention groups
Intervention group:
Corticotomy of maxilla on one side with lasercision 2780 nm, 30 hz, 3.5 W
Control group:
Corticotomy of maxilla on the side without lasercision
Main outcome variables
Primary outcome:
Assessing the canine movement
Assessing the molar movement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N280
Registration date:2019-05-22, 1398/03/01
Registration timing:retrospective
Last update:2019-05-22, 1398/03/01
Update count:0
Registration date
2019-05-22, 1398/03/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of corticotomy with and without lasercision on the canine retraction in orthodontic patients: a randomized clinical trial
Public title
Effect of corticotomy with and without lasercision on the canine retraction in orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15 to 30 years
Corticotomy of maxilla
Pulling bilateral premolars
Proper oral hygiene
Adequate thickness of adhesive gums (1 to 2 mm)
Exclusion criteria:
Active periodontitis
Probe depth of above 3 mm
A previous history of orthodontic
Any systematic disease
Vitamin D deficiency
Using NSAIDS drugs or hormonal supplements or tricyclic antidepressants
Age
From 15 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the right and left sides of the patients to the intervention and control groups through the tossing coin.
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 Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.UMSHA.REC.1397.969
Health conditions studied
1
Description of health condition studied
Orthodontic
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Assessing the canine movement
Timepoint
7 days after the intervention
Method of measurement
With physical examination
2
Description
Assessing the molar movement
Timepoint
7 days after the intervention
Method of measurement
With physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Corticotomy of maxilla on one side with lasercision 2780 nm, 30 hz, 3.5 W
Category
Other
2
Description
Control group: Corticotomy of maxilla on the side without lasercision
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan City
Full name of responsible person
Azadeh Kazemi Saleh
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azadeh.kazemisaleh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azadeh Kazemi Saleh
Position
Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 937 880 5023
Email
azadeh.kazemisaleh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Majid Mahmoodzadeh
Position
Orthodontist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
majidm2009@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available