The aim of this study is evaluation of displacement of maxillary first molars after distalization by using skeletal anchorage system in three dimensions. The sample is consist of 30 class II patients referred to the Hamadan faculty of dentistry. They will be included in the study according to molar relationship, which should not be more than one cusp in each side. Any patient with missing teeth or large restoration or any craniofacial malformation is excluded from the study. After provision of initial diagnostic records including impression and dental casts, a dentist places two mini screws, each with 8 mm in length and 1.4 mm in diameter under local anesthesia in palatal area. He inserts them between upper second premolar and first molar with self-tapping technique, about 5-6 mm from gingival crest with an angle of 20 to 30 degrees relative to the long axis of adjacent teeth. Mini screws are loaded with an average force of 150-200 gram-force/side by using of elastic modules connected to a Trans Palatal Arch (TPA), parallel to the occlusal plane. A CBCT will be taken to evaluate the precise position of mini screws relative to adjacent teeth and direction of the force relative to molar teeth. After distal movement to desired normal position, a new impression will be taken for final evaluation. The distance from central point of maxillary rugae to mesiopalatal cusp of first maxillary molars and the distance between mesiopalatal cusp of left and right molars will be measured to evaluate displacement of maxillary molars in horizontal plane.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302269085N3
Registration date:2013-07-14, 1392/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-14, 1392/04/23
Registrant information
Name
Amirfarhang Miresmaeili
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1823 9064
Email address
miresmaeili@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2013-04-12, 1392/01/23
Expected recruitment end date
2014-04-12, 1393/01/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Measuring maxillary first molars distal displacement after using a mini-screw supported appliance in class II patients in a before and after trial
Public title
Measuring backward movement of upper posterior teeth in orthodontic patients using a new distalizer appliance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Class II molar relation, presence of both maxillary molars on both side and need for distalization in orthodontic treatment Exclusion Criteria: Any craniofacial malformation, maxillary molar root resorption and more than one cusp Class II molar relation.
Age
From 13 years old to 35 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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, Hamadan University of Medical Sciences
Street address
Postcode: 65178-38677, Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
Approval date
2013-04-10, 1392/01/21
Ethics committee reference number
D/P/16/35/9/42
Health conditions studied
1
Description of health condition studied
Orthodontic patient with Class II molar relationship
ICD-10 code
K07.2
ICD-10 code description
Anomalies of dental arch relationship, Disto-occlusion
Primary outcomes
1
Description
Distal movement of maxillary molars (mm)
Timepoint
After completion of distalization
Method of measurement
Surface laser scanning of maxillary casts before and after trial
Secondary outcomes
1
Description
Buccal movement of maxillary first molars (mm)
Timepoint
After completion of distalization
Method of measurement
Surface laser scanning of maxillary casts before and after trial
Intervention groups
1
Description
Distal force will be applied to maxillary first molars using a palatal arch connecting right and left molars. An elastic module and ligature wire will be used for applying 150-200 gm force per side and will be changed every 3 weeks until completion of distalization.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Street address
Postcode: 65178-38677, Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Heidar Tavilani,
Street address
Postcode: 65178-518, School of Medicine, Shahid Fahmideh Street, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Position
Associate Professor
Other areas of specialty/work
Street address
Postcode: 65178-38677, Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
65178-38677
Phone
+98 81 1823 9064
Fax
+98 81 1823 4014
Email
amirfarhang@yahoo.com
Web page address
miresmaeili@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Position
Associate Professor
Other areas of specialty/work
Street address
Postcode: 65178-38677, Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
65178-38677
Phone
+98 81 1823 9064
Fax
+98 81 1823 4014
Email
amirfarhang@yahoo.com
Web page address
miresmaeili@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Position
Associate Professor
Other areas of specialty/work
Street address
Postcode: 65178-38677, Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
65178-38677
Phone
+98 81 1823 9064
Fax
+98 81 1823 4014
Email
amirfarhang@yahoo.com
Web page address
miresmaeili@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)