One of the main challenges for Orthodontists, is maintaining the results of orthodontic treatment. The aim of this study is to compare the orthodontic treatment results stability and gingival health between Hawley and vacum-formed retainers. In this randomized, single-blind study, 66 patients who have completed the comprehensive orthodontic treatment will be selected randomly and randomly divided into three equal groups of 22 patients. The first group will receive Hawley retainer and the second group vacuum-formed retainer with a thickness of 1 mm and the third group vacuum-formed with a thickness of 1.5 mm retainer. Patients will be matched for age, gender, type of malocclusion, crowding and treatment plan. The study variables are gingival health and orthodontic treatment results stability, which will be evaluated before retainer delivery and six months after delivery, based on Gingival Index and objective grading system, respectively. Inclusion criteria: completion of orthodontic treatment in a proper occlusion; indication of removable retainer. Exclusion criteria: The absence of several teeth and the need to replace them with prosthesis; patients with bruxism; syndromic disease (lip and palate clefts, hemi-facial microsomia); patients with allergy to acrylic resin; patients with temporomandibular joint problems.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021722951N3
Registration date:2017-04-28, 1396/02/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-28, 1396/02/08
Registrant information
Name
milad Ghanizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
milad.ghanizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Siences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-31, 1396/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of orthodontic treatment results stability and gingival health between Hawley and
vacum-formed retainers : randomized clinical trial
Public title
The comparison of treatment results of two types of retainers after orthodontic treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: completion of orthodontic treatment in a proper occlusion; indication of removable retainer. Exclusion criteria: The absence of several teeth and the need to replace them with prosthesis; patients with bruxism; syndromic disease (lip and palate clefts, hemi-facial microsomia); patients with allergy to acrylic resin; patients with temporomandibular joint problems.
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.TBZMED.REC.1395.1134
Health conditions studied
1
Description of health condition studied
Gingival Health
ICD-10 code
K00
ICD-10 code description
Disorders of tooth development and eruption
2
Description of health condition studied
orthodontic treatment stability
ICD-10 code
K00
ICD-10 code description
Disorders of tooth development and eruption
Primary outcomes
1
Description
Gingival Index
Timepoint
before retainer delivery and six months after delivery
Method of measurement
check list
2
Description
objective grading system method
Timepoint
before retainer delivery and six months after delivery
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
The patients of first group(Intervention) will receive Hawley retainer
Category
Other
2
Description
The patients of third group(Intervention) will receive vacuum-formed with a thickness of 1.5 mm retainer.
Category
Other
3
Description
The patients of second group(Intervention) will receive vacuum-formed retainer with a thickness of 1 mm
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
DR. Hossein Moslemzadeh
Street address
Research deputy of Tabriz University of Medical Sciences, Golgasht Avenue, Azadi 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 deputy of 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 University of Medical Sciences
Full name of responsible person
DR. Somayye Farshidnia
Position
Resident of orthodontics
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 9680
Fax
Email
milad.ghanizadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
DR. Somayye Farshidnia
Position
Resident of Orthodontics
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 9680
Fax
Email
milad.ghanizadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
DR Somayye Farshidnia
Position
Resident of Orthodontics
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 9680
Fax
Email
milad.ghanizadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)