Comparision of the effect of three different approaches of retention on reopening of extraction space of fixed orthodontic patients in three different retention phases
The aim of the present study is to evaluate the effect of three different retention techniques on the amount of reopening of the extraction space at different retention phase intervals in fixed orthodontic patients. The study design is random single-blind. The subjects will consist of patients receiving comprehensive orthodontic treatment in association with the extraction of mandibular first premolars.
The inclusion criteria consist of the presence of all the permanent teeth irrespective of third molars and the use of a fixed flexible spiral wire retainer or an extended fixed retainer or a fixed flexible spiral wire retainer along with a Hawley plaque. The exclusion criteria consist of missing teeth and the use of other types of retainers.
The study will be carried out on 90 patients in three groups, who are in the final phase of fixed orthodontic treatment. The intervention will consist of administration of an extended fixed retainer in group 1, a fixed flexible spiral wire retainer in group 2, and a fixed flexible spiral wire retainer along with a Hawley plaque in group 3.
The primary outcome which will be evaluated is the reopening of extraction space between the mandibular canine and second premolar on both sides, measured in millimeters by a leaf gauge in the patient’s oral cavity and on a stone cast at three different time intervals: on the debonding day, and 2 and 6 months after debonding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013113015598N1
Registration date:2014-10-25, 1393/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-25, 1393/08/03
Registrant information
Name
Farzaneh Rasouli
Name of organization / entity
dental faculty, Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5921
Email address
rasoulifa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the effect of three different approaches of retention on reopening of extraction space of fixed orthodontic patients in three different retention phases
Public title
Evaluating the success of fixed retainers in orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:the presence of all the permanent teeth irrespective of third molars; the use of a fixed flexible spiral wire retainer or an extended fixed retainer or a fixed flexible spiral wire retainer along with a Hawley plaque
Exclusion criteria:missing teeth; the use of other types of retainers
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Tabriz University of Medical Science
Street address
Ethics Committee of Tabriz University of Medical Sciences, Vice Chancellor for Research of Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, Golghasht street,Tabriz
City
Tabriz
Postal code
Approval date
2014-08-11, 1393/05/20
Ethics committee reference number
9373
Health conditions studied
1
Description of health condition studied
Evaluating the success of fixed retainers in orthodontic patients
ICD-10 code
Z46.4
ICD-10 code description
Fitting and adjustment of orthodontic device
Primary outcomes
1
Description
reopening of extraction space
Timepoint
debonding day, 2 month and 6 month after debonding day
Method of measurement
In millimetre by leaf guage
Secondary outcomes
empty
Intervention groups
1
Description
Extended fixed retainer in group 1
Category
Other
2
Description
flexible spiral wire retainer
Category
Treatment - Drugs
3
Description
Fixed flexible spiral wire retainer along with a Hawley plaque
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Farzaneh Rasouli
Street address
Faculty of Dentistry, Golgasht Avenue
City
Tabriz
2
Recruitment center
Name of recruitment center
private office
Full name of responsible person
Dr Aydin Sohrabi
Street address
Bolvar-e-Vali-e-Asr, Tabriz, Iran
City
Tabriz
3
Recruitment center
Name of recruitment center
private office
Full name of responsible person
Dr Ali Rafighi
Street address
17-Shahrivar
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzaneh Rasouli
Street address
Tabriz University of Medical Sciences, Golghasht street,Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Orthodontics Department of Dental Taculty,Tabriz University of Medical Sciences
Full name of responsible person
Farzaneh Rasouli
Position
post graduate student
Other areas of specialty/work
Street address
Orthodontics Department of Dental Taculty,Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3335 7314
Fax
Email
farzaneh.rasouli@yahoo.comRasoulifa@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Orthodontics Department of Tabriz Dental Faculty
Full name of responsible person
Dr Aydin Sohrabi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Orthodontics, Dental Faculty of Tabriz Medical University. Golgasht street
City
Tabriz
Postal code
5166614713
Phone
+98 41 3335 7314
Fax
Email
ay_sohrabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Orthodontics Department of Dental Faculty,Tabriz University of Medical Sciences
Full name of responsible person
Farzaneh Rasouli
Position
post graduate student of orthodontics
Other areas of specialty/work
Street address
Orthodontics Department of Dental Taculty,Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
5166614713
Phone
+98 41 3335 7314
Fax
Email
farzaneh.rasouli@yahoo.comRasoulifa@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)