To compare the stability of Iranian mini-screw with Korean mini-screw as an orthodontic anchorage
Design
This is a double-blind randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the School of Dentistry in Hamadan city on 76 eligible patients who need orthodontic. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 15 to 30 years
In need of orthodontic treatment
Indications for the use of mini-screws
Exclusion criteria:
Pregnancy
Being a smoker
Intervention groups
Intervention group 1:
Inserting the Iranian mini-screw made by Pouyan Teb Co. with a length of 8 mm and a diameter of 1.6 mm perpendicular to the bone using a manual driver in a predetermined place, then applying force immediately after loading the mini-screw with a force equivalent to 100 to 150 grams.
Intervention group 2:
Inserting the Korean mini-screw JEIL brand with a length of 8 mm and a diameter of 1.6 mm perpendicular to the bone using a manual driver in a predetermined place, then applying force immediately after loading the mini-screw with a force equivalent to 100 to 150 grams.
Main outcome variables
Primary outcome:
The degree of stability of Iranian and Korean mini-screws
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N479
Registration date:2023-08-01, 1402/05/10
Registration timing:prospective
Last update:2023-08-01, 1402/05/10
Update count:0
Registration date
2023-08-01, 1402/05/10
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
2023-08-11, 1402/05/20
Expected recruitment end date
2023-12-11, 1402/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the stability of Iranian mini-screw with Korean mini-screw as an orthodontic anchorage: a double-blind randomized clinical trial
Public title
Comparison of the stability of Iranian mini-screw with Korean mini-screw
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15 to 30 years
In need of orthodontic treatment
Indications for the use of mini-screw
Exclusion criteria:
Pregnancy
Being a smoker
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape, length and diameter of the mini-screws will be the same. Therefore, patients will be unaware of the type of intervention. The person who performs the randomization will be different from the person who examines the patients, so the person who examines the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
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
2023-05-06, 1402/02/16
Ethics committee reference number
IR.UMSHA.REC.1402.106
Health conditions studied
1
Description of health condition studied
Orthodontic mini-screw device
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device
Primary outcomes
1
Description
The degree of stability of Iranian and Korean mini-screws
Timepoint
In the first week and then the first, second and third month after treatment
Method of measurement
By clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Inserting the Iranian mini-screw made by Pouyan Teb Co. with a length of 8 mm and a diameter of 1.6 mm perpendicular to the bone using a manual driver in a predetermined place, then applying force immediately after loading the mini-screw with a force equivalent to 100 to 150 grams.
Category
Treatment - Devices
2
Description
Intervention group 2: Inserting the Korean mini-screw JEIL brand with a length of 8 mm and a diameter of 1.6 mm perpendicular to the bone using a manual driver in a predetermined place, then applying force immediately after loading the mini-screw with a force equivalent to 100 to 150 grams.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Anahita Morovat
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
anahita.morovat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
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
Anahita Morovat
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 81 3838 0572
Email
anahita.morovat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Nasrin Fahadian Langroodi
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
nasrinne@yahoo.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