The aim of this study is to compare the premolar space closure rate by using Ni-Ti closed coil springs and elastic memory chains. This clinical trial is carried out on a number of patients visited in the department of orthodontics of Ahvaz faculty of dentistry whose orthodontic treatment plan consists of bilateral extraction of first premolars in at least one jaw. The random patient selection process will continue among the patients with good cooperation in the first stages of orthodontic treatment until at least 21 dental arches are selected. After leveling and alignment, the patient will be referred to extract the premolars simultaneously. Then the space closure will be done with the use of Ni-Ti closed coil springs on one side and with the use of elastic memory chains on the other side. A digital caliper will be used to determine the extent of first premolar space closure during the third visit (3 months after initiation of retraction of canines). As this measurement is done after detaching the coils and elastics by another clinician, this study is done single blind. The rate of space closure is then calculated in millimeters per month and the results about Ni-Ti closed coil springs and elastic memory chains will be compared and analyzed statistically.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102824776N1
Registration date:2015-12-12, 1394/09/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-12, 1394/09/21
Registrant information
Name
Pedram Javidi Dashtbayazi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 5168
Email address
javidi.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur Unversity of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-02-04, 1394/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of premolar space closure rate using Ni-Ti closed coil springs and elastic memory chains
Public title
premolar space closure rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient needs simultaneous bilateral extractions of first premolars as a part of orthodontic treatment plan (in maxilla or mandible or both arches); good patient cooperation in orthodontic visits prior to teeth extractions.
Exclusion criteria: patient non-compliance in case of failure of the orthodontic appliance and not referring to clinic for more than two days after the appliance failure.
Age
No age limit
Gender
Both
Phase
N/A
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Dey St., Golestan highway, Ahvaz.
City
Ahvaz
Postal code
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.AJUMS.REC.1394.418
Health conditions studied
1
Description of health condition studied
Dental crowding
ICD-10 code
K07.4
ICD-10 code description
Malocclusion, unspecified
Primary outcomes
1
Description
tooth extraction space
Timepoint
1 month
Method of measurement
Digital caliper in milimeters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Elastic memory chain that is replaced with a new elastic in each treatment session to close the extraction space in intervention group.
Category
Other
2
Description
Control group: Ni-Ti closed coil spring to close the extraction space in control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Faculty of Dentistry, Department of Orthodontics
Full name of responsible person
Dr. Pedram Javidi Dashtbayazi
Street address
Faculty of Dentistry, Ahvaz Jundishapur University of Medical Sciences, Dey St., Golestan highway, Ahvaz.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Deputy of Research Development, Ahvaz Jundishapur University of Medical Sciences, Dey St., Golestan highway, 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 Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Pedram Javidi Dashtbayazi
Position
Postgraduate student of orthodontics
Other areas of specialty/work
Street address
Department of Orthodontics, Faculty of Dentistry, Ahvaz Jundishapur University of Medical Sciences, Dey St., Golestan highway, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 3320 5168
Fax
Email
javidi.p@ajums.ac.ir pjavidi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mashaallah Khanemasjedi
Position
Orthodontist
Other areas of specialty/work
Street address
Department of Orthodontics, Faculty of Dentistry, Ahvaz Jundishapur University of Medical Sciences, Dey St., Golestan highway, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 3320 5168
Fax
Email
masjedi_kh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Pedram Javidi Dashtbayazi
Position
Postgraduate student of orthodontics
Other areas of specialty/work
Street address
Department of Orthodontics, Faculty of Dentistry, Ahvaz Jundishapur University of Medical Sciences, Dey St., Golestan highway, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 3320 5168
Fax
Email
javidi.p@ajums.ac.ir pjavidi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)