The aim of study is comparison of survival time and satisfaction of Hawley and Vacuum-formed retainers in orthodontic patients. A multicenter study is designed that is single blind (analyzer). Participants are selected from patients that have completed orthodontic treatment in an optimum occlusion.They should have indication of use removable retainers. Patients randomly allocate to receive either a Hawley or a Vacuum-formed retainer. Subjects are excluded for the following reasons: prosthetic treatment of missing teeth, bruxism, syndromic disease (cleft lip & palate, hemifacial microsomia) and oral habits .Total sample size is 105 subjects, 35 per group. Our intervention is using one of three types of retainers (Hawley & two different thikness of Vacuum-formed retainers 1 and 1.5 mm). 1,3 and 6 months after debonding ,patient satisfaction evaluate by questionair and survival time measure by clinical evaluation of retainers in terms of fracture, crack, color change and fittness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022926836N1
Registration date:2016-04-29, 1395/02/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-04-29, 1395/02/10
Registrant information
Name
Seyed Hossein Moslemzadeh
Name of organization / entity
Faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
hmoslemzadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice-chancellor,Tabriz University of Medical Sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2017-01-04, 1395/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of survival time and satisfaction of Hawley and Vacuum-formed retainers in orthodontic patients – a randomized clinical trial
Public title
Comparison of two types of retainers used after orthodontics treatment in terms of survival time and patient satisfaction
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: orthodontic treatment in an optimal occlusion; indication of use removable retainer; patients filling to participate in the study
exclusion criteria: prosthetic treatment of missing teeth; bruxism; syndromic disease (cleft lip & palate, hemifacial microsomia); alergy to acrylic resins; TMD; oral habits; maxillary expansion treatment; early debonding; generalized spacing
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
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 Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Postal code
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
TBZMED.REC.1394.1188
Health conditions studied
1
Description of health condition studied
survival time and patient satisfaction from used retainers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient satisfaction of Hawley and Vacuum-formed retainers
Timepoint
1,3,6 months after debonding
Method of measurement
questionair
2
Description
Survival time of Hawley and Vacuume-formed retainers
Timepoint
1,3,6 months after debonding
Method of measurement
clinical evaluation of retainers for fracture
Secondary outcomes
1
Description
crack, color change , retainer lost, fittness
Timepoint
1,3,6 months after debonding
Method of measurement
clinical evaluation
Intervention groups
1
Description
first intervention group: use Hawley retainer in upper arch
Category
Prevention
2
Description
second intervention group: use Vacuum-formed retainers with 1 mm thickness in upper arch
Category
Prevention
3
Description
third intervention group: use Vacuum-formed retainers with 1.5 mm thickness in upper arch
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Private Clinic
Full name of responsible person
Dr. Seyed Hossein Moslemzade
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Private Clinic
Full name of responsible person
Dr. Ali Rafighi
Street address
City
Tabriz
3
Recruitment center
Name of recruitment center
Private Clinic
Full name of responsible person
Dr. Aydin Sohrabi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-Chancellor, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rashidi
Street address
Tabriz University of Medical Sciences, University 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
Research Vice-Chancellor, 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
Tabriz Faculty of Dentistry
Full name of responsible person
Dr. Somaye Rahmanian
Position
Orthodontics Resident
Other areas of specialty/work
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 0061
Fax
Email
somaieh.rahmanian93@gmail
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Faculty of dentistry
Full name of responsible person
Dr Seyed Hossein Moslemzadeh
Position
Orthodontist
Other areas of specialty/work
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7539
Fax
Email
Hmoslemzadeh@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Faculty of dentistry
Full name of responsible person
Dr Somaye Rahmanian
Position
Orthodontics Resident
Other areas of specialty/work
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 0061
Fax
Email
somaieh.rahmanian93@gmail
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)