Protocol summary

Summary
Corrosion of orthodontic alloys may releases nickel and chromium ions, resulting contact allergy, asthma, or hypersensitivity. The effect of orthodontic treatment on systemic levels of chromium and nickel is disputed, demonstrating lack of changes or increases. Except one recent study, all previous researches are performed on casting brackets, results of which are not necessarily generalizable to novel orthodontic technologies, MIM brackets, which may corrode in other way. Metal injection molding (MIM) brackets have been designed to eliminate intra-bracket galvanic corrosion through one-piece design, uniform elemental distribution and lack of soldering between the bracket parts. The aim of this study is evaluating the hair concentration of nickel and chromium in hair specimens obtained from 46 orthodontic patients in two groups of casting brackets (AISI 316L, Stratus, Fairfield Orthodontic, United States) and MIM brackets (AISI 316L, Gem Petit, Fairfield Orthodontic) . This measurement will be performed in two travels, immediately before treatment, and 6 months after starting of fixed orthodontic treatment. The inclusion criteria are: having indication of fixed orthodontic treatment, lack of any systemic disease and absence of any hair color or hairdressing. The patients will be divided in two groups of casting (control) and MIM (experimental) brackets (n = 23 in each group) . The randomization will be done by an orthodontist, based on a random number table. The orthodontist is the only person who knows allocation. The laboratory expert and the patients will be blinded about bracket allocation. The hair specimens will be sent to Chemical Analysis Laboratory for atomic absorption spectrophotometry.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120625379N1
Registration date: 2016-01-29, 1394/11/09
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-29, 1394/11/09
Registrant information
Name
Nima Haghighatjahromi
Name of organization / entity
Ahvaz Jondishapour medical science university, Dentistry college
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 1005
Email address
haghighatj.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Ahvaz Jondishapour medical science university
Expected recruitment start date
2016-01-30, 1394/11/10
Expected recruitment end date
2016-03-30, 1395/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of fixed orthodontic treatment using casting versus metal injection molding (MIM) brackets on hair nickel and chromium levels
Public title
Effect of two kinds of orthodontic brackets on nickel and chromium ions levels in hair sample of patients
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion and exclusion criteria: Subjects’ willingness to participate, having indication of fixed orthodontic treatment, having all permanent teeth fully erupted (no semi-eruptions, no missing or extraction) excluding third molars, lack of any systemic diseases, history of allergic reactions, smoking or alcohol consumption, absence of any caries, lack of any metal restorations (e.g., amalgam fillings or fixed prostheses) before or during treatment, having adequate length scalp hair, and absence of any hair color or hairdressing.
Age
From 12 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Jondishapour medical science university
Street address
Jondishapour medical science university, No 1, Mehr Alley, Day St, Golestan Ave, Ahvaz
City
Ahvaz
Postal code
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
IR.AJUMS.REC.1394.516

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
release of nickel ion
Timepoint
before intervention-6 months after intervention
Method of measurement
measure:microgram/gram dry hair mass- high resolution continuum source(AAS Contra AA700, Analytik Jena, Germany)

2

Description
release of chromium ion
Timepoint
before intervention-6 months after intervention
Method of measurement
microgram/gram dry hair mass- high resolution continuum source (AAS Contra AA700, Analytik Jena, Germany)

Secondary outcomes

empty

Intervention groups

1

Description
control group:bonding of stainless steel casting bracket (Fairfield Orthodontic, United States) 0.022 inch slot on upper and lower teeth
Category
Other

2

Description
intervention group: Bonding of stainless steel metal injection molding bracket (Fairfield Orthodontic, United States) 0.022 inch slot on upper and lower teeth
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthodontic department of dentistry college
Full name of responsible person
Nima Haghighatjahromi
Street address
Dentistry college, Jondishapour medical science university, No 1, Mehr Alley, Day St, Golestan Ave, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy of Jondishapour medical science
Full name of responsible person
Nader Saki
Street address
Research deputy, Jondishapour medical science university, No 1, Mehr Alley, Day St, Golestan Ave, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Jondishapour medical science
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
Jondishapour medical science university
Full name of responsible person
Nima Haghighatjahromi
Position
Resident of orthodontics
Other areas of specialty/work
Street address
Dentistry college, Jondishapour medical science university, No 1, Mehr Alley, Day St, Golestan Ave, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3338 1005
Fax
Email
haghighatnimaa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jondishapour medical science university, dentistry college
Full name of responsible person
Mashallah Khanemasjedi
Position
Associate professor of orthodontics
Other areas of specialty/work
Street address
Dentistry college, Jondishapour medical science university, No 1, Mehr Alley, Day St, Golestan Ave, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
masjedi kh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapour medical science university, Dentistry college
Full name of responsible person
Nima Haghighatjahromi
Position
Resident of orthodontics
Other areas of specialty/work
Street address
Dentistry college, Jondishapour medical science university, No 1, Mehr Alley, Day street, Golestan Ave, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3338 1005
Fax
Email
haghighatj.n@ajums.ac.ir haghighatnimaa@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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