1)The aim of this study is evaluating the effect of titanium nitride coating on the extent of bacterial adhesion to the orthodontic stainless steel arch wires.
2)Design of the study is split mouth.
3)Setting and conduct: 20 patients (age 15-25) undergoing fixed orthodontic treatment at Islamic Azad University of Medical Sciences Dental School (year 94-95) will be selected.
4) inclusion criteria is that patients have the indication for placement of 19*25 SS archwires in both jaws. Exclusion criteria is consumption of antibiotics and antibacterial mouthwashes during this experiment.
5) each patient will serve as their own control, the coated archwire will randomly be assigned to one jaw and the opposing jaw will recieve a non-coated archwire. after 4 weeks, the archwires willbe removed and cut at the same lengths,the samples will be placed in sterile dishes containing saline phosphate buffer and sent to the laboratory.
6)bacterial colonies will be counted after culturing on blood agar plates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021431250N2
Registration date:2017-03-07, 1395/12/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-07, 1395/12/17
Registrant information
Name
Fariborz Amini
Name of organization / entity
Islamic Azad University Of Medical Sciense Dental School
Country
Iran (Islamic Republic of)
Phone
+98 21 2212 1619
Email address
f_amini@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Of Medical Science Dental School
Expected recruitment start date
2016-01-02, 1394/10/12
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of the Titanium nitride coating on bacterial adhesion on orthodontic stainless steel wires: invivo study
Public title
The Effect of the Titanium nitride coating on bacterial adhesion on orthodontic stainless steel wires
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: patients which indication for placement of 19*25 Stainless steel archwires in both jaws
exclusion criteria: consumption of antibiotics and antibacterial mouthwashes
Age
From 15 years old to 25 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
_
Secondary trial Id
_
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Islamic Azad University of Medical Science Dental School
Street address
No 4 , 10th Neyestan, Pasdaran St, Tehran
City
Tehran
Postal code
Approval date
2016-08-20, 1395/05/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,5
Health conditions studied
1
Description of health condition studied
Bacterial adhesion on TiN coated orthodontic stainless steel wire
ICD-10 code
_
ICD-10 code description
_
Primary outcomes
1
Description
Amount of Bacterial colonies
Timepoint
4 weeks after placement wires
Method of measurement
Colony count
Secondary outcomes
empty
Intervention groups
1
Description
19*25 Stainless steel archwires will be evaluated, each patients will be their own control, the coated archwire will be assigned to one jaw randomly. After 4 weeks, the archwires will be removed and cut at similar lengths of 20 mm. they will be placed in sterile dishes containing saline phosphate buffer and sent to the lab for bacterial colony counting that includes dilution and culture on blood agar plates and eventually counting the colonies. each sample will be counted 3 times and the average number will be recorded.
Category
Other
2
Description
The opposing jaw as a control group will be recieve a non-coated 19*25 Stainless steel archwire. After 4 weeks, the archwires will be removed and cut at similar lengths of 20 mm. they will be placed in sterile dishes containing saline phosphate buffer and sent to the lab for bacterial colony counting that includes dilution and culture on blood agar plates and eventually counting the colonies. each sample will be counted 3 times and the average number will be recorded.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Medical Science Dental School
Full name of responsible person
Dr Fariborz Amini
Street address
No 4 , 10th Neyestan, Pasdaran St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University of Medical Science Dental School
Full name of responsible person
Dr Arash Azizi
Street address
No 4 , 10th Neyestan, Pasdaran St, Tehran
City
Tehran
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, Islamic Azad University of Medical Science Dental School
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
Islamic Azad University of Medical Science Dental School
Full name of responsible person
Dr Fariborz Amini
Position
Professor
Other areas of specialty/work
Street address
No 4 , 10th Neyestan, Pasdaran St, Tehran
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
F_amini@dentaliau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Medical Science Dental School
Full name of responsible person
Dr Fariborz Amini
Position
Professor
Other areas of specialty/work
Street address
No 4 , 10th Neyestan, Pasdaran St, Tehran
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
F_amini@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamiz Azad University of Medical Science Dental School
Full name of responsible person
Dr Bita Kiaee
Position
Resident of Orthodontics
Other areas of specialty/work
Street address
No 4 , 10th Neyestan, Pasdaran St, Tehran
City
Tehran
Postal code
Phone
+98 21 2212 1619
Fax
Email
Bitakiaie@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)