This study is designed to compare the response to mandibular growth modification treatment in class II division I patients with vertical and normal growth pattern with Twin Block appliance for the purpose of optimal use of this appliance in the treatment.
Patients should have class II molar relationship and an over jet greater than 6 mm, they should be in late mix or early permanent dentition. Patients should not use any kind of appliance for class II treatment except palatal expansion. They should not have systemic disease, craniofacial syndrome and history of orthodontic treatment.
All of the patients referred to the orthodontics department of Hamadan university of medical science, who have the inclusion criteria and are volunteer for treatment will be selected.
At the beginning of treatment a lateral cephalogram is taken and then the Twin Block appliance will be delivered to the patients. At least 6 months after the start of treatment and when the occlusion become stable and over jet is reduced to 1-2 millimeters, the second radiography will be taken.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082716582N1
Registration date:2014-11-08, 1393/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-08, 1393/08/17
Registrant information
Name
Vahid Mollabashi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3835 2555
Email address
mollabashi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cephalometric comparison of treatment with Twin Block appliance in skeletal class II div 1 patients with normal and vertical growth pattern
Public title
The comparison of the effect of mandibular growth stimulator appliance in patients with different growth pattern.
Purpose
Treatment
Inclusion/Exclusion criteria
nclusion criteria: class II division I malocclusion with mandibular deficiency; class II molar relationship; overjet greater than 6 mm; in late mix or early permanent dentition. Exclusion criteria: systemic disease; craniofacial syndrome; history of orthodontic treatment.
Age
From 9 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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, Hamadan University of Medical Sciences
Street address
Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamedan
Postal code
65178-38677
Approval date
2014-05-20, 1393/02/30
Ethics committee reference number
801/9/35/16/پ
Health conditions studied
1
Description of health condition studied
malocclusion
ICD-10 code
K07.1
ICD-10 code description
Anomalies of jaw-cranial base relationship
Primary outcomes
1
Description
Reduction of overjet to 1 to 2 millimeter
Timepoint
After completion of functional therapy
Method of measurement
Cephalometric analysis with the aid of dolphin software before and after treatment
Secondary outcomes
1
Description
vertical growth control during treatment.
Timepoint
After completion of functional therapy
Method of measurement
Cephalometric analysis with the aid of dolphin software before and after treatment
Intervention groups
1
Description
patients with FMA less than 28 degrees treated with twin block appliance
Category
Treatment - Devices
2
Description
pateints with FMA more than 28 degrees treated with twin block functional appliance
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Dr Vahid Mollabashi
Street address
Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamedan
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 Saied Bashiriyan
Street address
School of Medicine, Shahid Fahmideh Street, Hamadan 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 Vahid Mollabashi
Position
Assistant professor
Other areas of specialty/work
Street address
Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan