comparison of the effect of NiTi , copper NiTi and epoxy coated NiTi wires on salivary nickel changes in orthodontic patients with metal injection molding brackets
However nickel is known as an allergic and cytotoxic metal and despite the importance of nickel release from orthodontic appliances, there are no in vivo and very few in vitro studies on this issue in the case of orthodontic wires. The aim of this study is to compare the effect of three types of orthodontic wires on salivary nickel contents. This research has planned randomly, single blind and without placebo and will done by an orthodontist. This study contains three groups and who will know wire allocations in each group is only the orthodontist. The patients will be blind of wire allocations. For this purpose, saliva samples will all be coded, and patients won't be informed of their wire type. Samples contain of 42 orthodontic patients which will randomly divide to three groups, saliva samples collect in two stages, first stage is before bonding brackets and wire engagement and the second stage will be two months later. Bracket and wire type which allocate in every group are as follows:
1- Metal Injection Molding(MIM) bracket + Nickel-Titanium(NiTi) wire.
2- MIM bracket + Copper NiTi wire.
3- MIM bracket + Epoxy coated NiTi wire.
Inclusion criteria are as follows: All of the patients should need fixed orthodontic treatment; They should not have intra oral crown and amalgam restoration; Should not smoke, drink alcohol and use special drugs; Should not have systemic disease and special diet; They should be inclined to long term cooperation. And exclusion criteria are as follow: Disinclination to continue cooperation; Have done any intra oral metal restoration; Have used alcohol or cigarette.
Main intervention in this study is wire type such as Ni-Ti, Ni-Ti-Cu and Epoxy coated Ni-Ti and the primary outcome is nickel releasing which will be measured using atomic absorption spectrometry.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120725408N1
Registration date:2016-02-03, 1394/11/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-03, 1394/11/14
Registrant information
Name
Ozra Niknam
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 5168
Email address
niknam.o@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of NiTi , copper NiTi and epoxy coated NiTi wires on salivary nickel changes in orthodontic patients with metal injection molding brackets
Public title
comparison of the effect of three types of orthodontic wires on salivary nickel changes in orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All of the patients should needed fixed orthodontic treatment; They should not have intra oral crown and amalgam restoration; Should not smoke, drink alcohol and use special drug; Should not have systemic disease and special dietry; They should be inclined to long term cooperation.
Exclusion criteria: Disinclination to continue cooperation; Have done any intra oral metal restoration; Have used alcohol or cigarette.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, No 101, Mehr Alley, Esfand St, Golestan Ave, Ahvaz.
City
Ahvaz
Postal code
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
IR.AJUMS.REC.1394.455
Health conditions studied
1
Description of health condition studied
Malocclusion
ICD-10 code
k07.4
ICD-10 code description
malocclusion,unspecified
Primary outcomes
1
Description
Nickel ion releasing
Timepoint
Before intervention ; 2 months after intervention
Method of measurement
Measure: Microgram/Milliliter by atomic absorption spectrometry machine
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Metal injection molding(MIM) bracket + nickel-titanium (NiTi) wire
Category
Other
2
Description
Intervention group:
Metal injection molding(MIM) bracket + Copper nickel-titanium wire