The purpose of this single arm study is to determine levels nickel and chromium in saliva in patients with fixed orthodontic appliances. This study included 32 orthodontic patients treated with fixed orthodontic appliances. The intervention under study is different orthodontic wires (first to third months: Niti wire from forth months: Stainless steel wire). Saliva samples are collected before the interventions and 1, 3, and 6 months after insertion of appliances. The samples will be kept at -20 degree until they will be processed. The spectrophotometric determination will be carried out using an electrothermal atomic absorbtion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011132481N2
Registration date:2010-12-18, 1389/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-18, 1389/09/27
Registrant information
Name
Soghra Yassaei
Name of organization / entity
Dental School
Country
Iran (Islamic Republic of)
Phone
+98 35 1823 8087
Email address
syassaei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Assistance of Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An investigation on the amount of salivary nickel and chromium in patients with fixed orthodontic appliances
Public title
An investigation on the amount of salivary nickel and chromium in patients with fixed orthodontic appliances
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: having permanent dentition, not having any amalgam and metal restoration, having 22 Roth brackets and bands on the teeth, having any palatal or lingual appliances welded to bands, having extraoral appliance (i.e., head gear)
Exclusion criteria: unwilling to continue in the study
Age
From 12 years old to 24 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research, Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Postal code
Approval date
2009-11-07, 1388/08/16
Ethics committee reference number
77391/1/17/پ
Health conditions studied
1
Description of health condition studied
Dental malocclusion
ICD-10 code
K07
ICD-10 code description
Dentofacial anomalies
Primary outcomes
1
Description
salivary nickel and chromium
Timepoint
Pre intervention, 1, 3, 6 months after intervention
Method of measurement
salivary of patients
Secondary outcomes
empty
Intervention groups
1
Description
Different orthodontic wires, first to third months: Niti wire from fourth months: Stainless steel wire
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Private orthodontic clinic
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Soghra Yassaei
Street address
Department of Orthodontic, Faculty of Dentistry, Dahaye Fajr Blvd, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Faculty of Dentistry
Full name of responsible person
Soghra Yassaei
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Orthodontic, Faculty of Dentistry
City
Yazd
Postal code
Phone
+98 35 1621 2222
Fax
Email
syassaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Soghra Yassaei
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Orthodontic, Faculty of Dentistry Dahaye Fajr Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 1621 2222
Fax
Email
syassaei@yahoo.comsyassaei@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)