The aim of this randomized, single blind study is to compare the success rate of cylindrical and taper miniscrews in orthodontic treatment. The samples will be selected from the patients admitted to the orthodontic department of dental faculty of Tabriz University of Medical Sciences or the private office of proposal administrator in 2016-2017. Inclusion criterion is a treatment plan of orthodontic miniscrew placement on each side of maxilla to provide absolute anchorage for anterior teeth retraction. Patients with any compromising bone disease will be excluded. According to the effect of age on success rate of miniscrews, stratified randomization will be done among patients under and over 16 years old. Patients will randomly be allocated to intervention (taper miniscrews) and control (cylindrical miniscrews) groups. 106 taper miniscrews in 53 patients of intervention group and 106 cylindrical miniscrews in 53 patients of control group (212 miniscrews in 106 patients overall) will be inserted on each side of maxilla between first molar and second premolar. Insertion torque will be measured by torque measurement device. The patient will be unaware of study groups but the clinician will be aware of miniscrew design, inevitably. The mobility as an indicator of miniscrew failure will be evaluated every 4 weeks up to 40 weeks. The amount of pain will be registered by the patient immediately after miniscrew placement and 6hours, 24hours, 48hours, and a week after in a special form. The primary outcomes are to be no significant difference in clinical success rate and/or pain between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607049569N3
Registration date:2016-08-02, 1395/05/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-02, 1395/05/12
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
Dental Faculty, Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of taper and cylindrical miniscrew designs on clinical success rate and pain in orthodontic patients
Public title
Effect of miniscrew design on survival rate and pain 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 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
212
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 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
2016-07-26, 1395/05/05
Ethics committee reference number
IR.TBZMED.REC.1395.417
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 miniscrews
Timepoint
every 4 weeks after miniscrew placement
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
pain
Timepoint
immediately after miniscrew placement and 6hours, 24hours, 48hours, and a week after
Method of measurement
registeration of the amount of pain from 0 (minimum pain) to 10 (maximum pain) according to Visual Analogue Scale in special times
Control group: 106 cylindrical miniscrews manufactured by General Implant Company, with a diameter of 1.6mm and a length of 11mm will be inserted on both sides of maxilla between second premolar and first molar in 53 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. miniscrews will be loaded immediately.
Category
Treatment - Other
2
Description
Intervention group: 106 taper miniscrews manufactured by General Implant Company, with a diameter of 1.6mm and a length of 11mm will be inserted on both sides of maxilla between second premolar and first molar in 53 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. 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 41 3329 4312
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
5166614713
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
Afsaneh Zarghami Khanehsar
Position
Postgraduate 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
+98 41 3381 4338
Fax
Email
f_afsaneh_z@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)