The aim of this study is to evaluate the health care delivery system. This is a randomized, double-blind study. The samples will be selected from the patients admitted to the Orthodontic Department of Dental Faculty of Tabriz University of Medical Sciences in 2011-2012. Inclusion criterion is a treatment plan to insert an orthodontic miniscrew implant on each side of the maxilla. The exclusion criteria consist of any disease that influences bone quality such as osteoporosis, osteomalasia, osteopetrosis, and any metabolic bone disease. There will be 60 sample miniscrews. In each patient, a miniscrew placed on each side of the maxilla between first molar and second premolar. One of the miniscrews will be surface-roughened and the other one will be an ordinary one. The patients and the operator inserting the miniscrews will be blind to which side has a surface roughened miniscrew. Our primary expected outcome is to increase in clinical success rate (no mobility) of the surface-roughened orthodontic miniscrew implants in comparison with ordinary ones.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204289569N1
Registration date:2012-06-27, 1391/04/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-27, 1391/04/07
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
Vice Chancellor for Research of Tabriz University of Medical Sciences
Expected recruitment start date
2012-05-09, 1391/02/20
Expected recruitment end date
2012-06-09, 1391/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Clinical Success Rates of Surface Roughened Orthodontic Miniscrews with Conventional One
Public title
The Influence of Surface Roughening of Orthodontic Miniscrews on Their Clinical Success Rate
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.
Exclusion criteria: Any disease compromising bone quality like osteoporosis, osteopetrosis, osteomalasia.
Age
From 10 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The operator inserting the miniscrews has two miniscrew boxes. Box “A” and box “B”. Only miniscrews in box “A” have been roughened. He knows that the miniscrews of one of the boxes have been roughened, but he does not know which one of the boxes has the roughened miniscrews. He just inserts the miniscrews of box “A” on the right side and the miniscrews of box “B” on the left side in the odd number patients (according to referral). Conversely, in the even number patients, he places the miniscrews of box “B” on the right side and the miniscrews of box “A” on the left side.
All the patients know that the miniscrew on one of the sides is roughened, but they do not know which one of them is roughened.
Therefore, the patients and the operator who inserts the miniscrews do not know which one of the inserted miniscrews is roughened; This study as aresult is a double-blind clinical trial.
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, Tabriz
City
Tabriz
Postal code
51665-118
Approval date
2012-04-05, 1391/01/17
Ethics committee reference number
308/4/6
Health conditions studied
1
Description of health condition studied
Orthodontic Anchorage Procedures
ICD-10 code
T84.9, Z45
ICD-10 code description
Unspecified complication of internal orthopaedic prosthetic device, implant and graft; Adjustment and management of other implant devices
Primary outcomes
1
Description
Detection of mobility in the miniscrews
Timepoint
Six weeks and six months after insertion of the miniscrew
Method of measurement
Check list to record the mobility
Secondary outcomes
1
Description
Amount of removal torque of the miniscrews
Timepoint
Six months after insertion of miniscrews
Method of measurement
Torque measurment device (Orthonia, JEIL Company)
Intervention groups
1
Description
Sixty miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 10mm will be randomly divided into case and control groups. The case group samples will be roughened by sandblasting and acid etching. Surface roughening will be carried out as follows: First of all, the miniscrews will be polished and sandblasted with aluminum oxide particles under the pressure of 4MPa. Then irrigation will be carried out with acetone, 75% alcohol ethylic, and distilled water in an ultrasonic cleanser for 15 minutes, in turn. Subsequently the samples will be put in a solution of hydrofluoric acid with a concentration 0.11 mol per liter and nitric acid with a concentration of 0.09mol per liter at room temperature for 10 minutes. Then the samples will be maintained in an oven at 50°C for 24 hours. Subsequently the samples will be put into a solution of hydrochloric acid with a concentration of 5.8mol per liter and sulfuric acid with a concentration of 8.96mol per liter at 80°C for 30 minutes. Finally, an oven at 50°C will be used for drying the miniscrews for 24 hours.
Category
Treatment - Devices
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 St
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
Vice Chancellor for Research, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Grant name
10506
Grant code / Reference number
برنامه
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 St
City
Tabriz
Postal code
5166614713
Phone
+98 411335596
Fax
+98 41 1334 6977
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 St
City
Tabriz
Postal code
5166614713
Phone
+98 41 1329 4312
Fax
+98 41 1334 6977
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
Saeid Foroughi Moghaddam
Position
Post-graduate student
Other areas of specialty/work
Street address
6.47, Bahram Alley, Lalehzar Avenue
City
Tabriz
Postal code
5173764174
Phone
+98 41 1479 6363
Fax
Email
saidforoughi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)