The Comparison of Clinical Success Rates of Orthodontic Miniscrews with three different loading times: immediately, six and fourteen weeks after miniscrew placement in orthodontic patients
The aim of this study is to evaluate success rate of orthodontic miniscrews with different loading times after their insertion. This is a randomized, not blind study. The samples will be selected from the patients admitted to the orthodontic department of dental faculty of Tabriz university of medical sciences and the office of proposal administrator in 2013-2014. Inclusion criterion is a treatment plan to insert an orthodontic miniscrew implant on each side of the maxilla between second premolar and first molar for anchorage reinforcement in anterior teeth retraction. There will be 180 sample miniscrews. In each patient, a miniscrew will be placed on each side of the maxilla between first molar and second premolar. Insertion torque will be measured by torque measurement device. According to the effect of age on success rate of miniscrews، the patients will be divided into two groups under 16 years old and older than 16 years old for assimilating of groups. Each of the patients less than 16 years old randomly will settle in one of these three loading groups: loading immediately, loading 6 weeks after miniscrew placement and loading 14 weeks after miniscrew placement. Each of the patients older than 16 years old also will settle randomly in one of these three loading groups. Because the patient and the clinician inevitably will be aware of loading time, so it will not be possible to blind this study. The mobility will be evaluated three weeks after miniscrew placement, six weeks after miniscrew placement, ten weeks after miniscrew placement and then every 4 weeks. Our primary expected outcome is to be no difference in clinical success rate (no mobility) of three groups of loading time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311069569N2
Registration date:2014-12-06, 1393/09/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-06, 1393/09/15
Registrant information
Name
Amir Mohammadi
Name of organization / entity
Department of Orthodontics of Dental Faculty of Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
mohammadia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz dental faculty, Tabriz university of medical sciences
Expected recruitment start date
2013-12-01, 1392/09/10
Expected recruitment end date
2015-04-01, 1394/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Clinical Success Rates of Orthodontic Miniscrews with three different loading times: immediately, six and fourteen weeks after miniscrew placement in orthodontic patients
Public title
The effect of different loading times on loosening of miniscrews in orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: A treatment plan to insert miniscrews on both sides of maxilla between the second premolar and the first molar for retraction of anterior teeth.
Exclusion criteria: Any disease compromising bone quality like osteoporosis, osteomalasia, and osteopetrosis.
Age
From 10 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This site has been used for randomization and allocation: http://www.graphpad.com/quick calcs/index.cfm .
With attention to the patient age, stratified randomization will be done. Patients less than 16 years old randomly will settle in one of these three loading groups: loading immediately, loading 6 weeks after miniscrew placement and loading 14 weeks after miniscrew placement. Patients older than 16 years old also will settle randomly in one of these three loading groups. According to the previous study, 20 patients of 30 patients are older than 16 years old and 10 patients are under 16 years old.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethics committee of Tabriz university of medical sciences, vice chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2014-08-11, 1393/05/20
Ethics committee reference number
9374
Health conditions studied
1
Description of health condition studied
Orthodontic Anchorage Procedures
ICD-10 code
Z45.8
ICD-10 code description
Adjustment and management of other implanted devices
Primary outcomes
1
Description
Mobility in the miniscrews
Timepoint
Three weeks after miniscrew placement, six weeks after miniscrew placement, ten weeks after miniscrew placement and then every 4 weeks
Method of measurement
By placing a calibrated probe on the miniscrew and lateral movement, if mobility is greater than 0.5 millimeter, the miniscrew is designated mobile
2
Description
mobility in two groups less than 16 years old and older than 16 years old
Timepoint
Three weeks after miniscrew placement, six weeks after miniscrew placement, ten weeks after miniscrew placement and then every 4 weeks
Method of measurement
By placing a calibrated probe on the miniscrew and lateral movement, if mobility is greater than 0.5 millimeter, the miniscrew is designated mobile
180 miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 11mm will be inserted in 90 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. According to the age of patients, stratified randomization will be done. The patients randomly divided into 3 groups of loading time. In intervention group 1, miniscrews will be loaded after 6 weeks from minisrcrew insertion.
Category
Treatment - Other
2
Description
180 miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 11mm will be inserted in 90 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. According to the age of patients, stratified randomization will be done. The patients randomly divided into 3 groups of loading time. In intervention group 2, miniscrews will be loaded after 14 weeks from minisrcrew insertion.
Category
Treatment - Other
3
Description
180 miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 11mm will be inserted in 90 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. According to the age of patients, stratified randomization will be done. The patients randomly divided into 3 groups of loading time: control group and two intervention groups. In control group miniscrews will be loaded immediately.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of orthodontics of dental faculty of Tabriz university of medical sciences
Full name of responsible person
Amir Mohammadi
Street address
Department of orthodontics, Tabriz dental faculty, Tabriz university of medical sciences, Golgasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tabriz university of medical sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
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 Tabriz university of medical sciences
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
Department of orthodontics of dental faculty of Tabriz university of medical sciences
Full name of responsible person
Amir Mohammadi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of orthodontics, Tabriz dental faculty, Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 413335596
Fax
Email
amirortho@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of orthodontics of dental faculty of Tabriz university of medical sciences
Full name of responsible person
Amir Mohammadi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of orthodontics, Tabriz dental faculty, Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3329 4312
Fax
Email
amirortho@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of orthodontics of dental faculty of Tabriz university of medical sciences
Full name of responsible person
Sareh Keshavarz Meshkinfam
Position
Post-graduate student
Other areas of specialty/work
Street address
Department of orthodontics, Tabriz dental faculty, Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
Phone
00
Fax
Email
sare.keshavarz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)