The aim of this study is comparison of treatment results and patients satisfaction of classic twin block and clear twin block.The sample is consists of 66 patients who refer to private clinic and Hamedan Faculty of dentistry with class II,div 1 malocclusion and 4 to 8 millimeter overjet. Patients with history of trauma to jaws and craniofacial syndromes are excluded from study. Initial records such as cephalometric radiograph are provided for each patient before treatment. If transverse expansion in upper dental arch is needed, expander appliance is used before functional treatment. The patients are randomly placed in two groups. In the first group, classic twin block are used. This appliance is composed of removable acrylic upper and lower plate with retentive wire components and 70 degree inclined plans. In second group, clear twin block are used. This appliance is made from clear acrylic sheets of 1.5-millimeter thickness that compress on dental casts with vacuum device. After mounting on the articulator, 70 degree inclined plans are made with acryl. The appliances are used at least for 8 months, until reduction of overjet to 1 to 2 millimeter and reaching first molars to occlusions. After that, cephalometric radiograph are taken from patients. The implication of the study are comparison of treatment results of this two appliances with cephalometric measurements before and after treatment with the help of Dolphin software, and evaluation of patients satisfaction from orthodontic treatment 4 months after initial visits with sergel questionnaire according to Likert scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040817180N1
Registration date:2014-04-30, 1393/02/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-30, 1393/02/10
Registrant information
Name
Mohammad Karim Soltani
Name of organization / entity
Hamedan Dental Faculty, Orthodontic Department
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 1059
Email address
m.k.soltani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2014-05-10, 1393/02/20
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of treatment results and patient satisfaction of Classic Twin-block and Clear Twin-block in classII, div 1 malocclusions.
Public title
Comparison of performance of two kinds of lower jaw growth stimulator device in patients with deficiency in lower jaw growth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 8 to 11 years old; overjet of 4 to 8 millimeter; class II, division 1 malocclusion with ANB angle greater than 3 degree; Frankfort mandibular angle between 20 to 25 degree; being in cervical vertebral maturation stage of 1 to 3.
Exclusion criteria: craniofacial syndromes; history of trauma to jaws; history of orthodontic treatment or premolar extraction.
Age
From 8 years old to 11 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)
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
Postcode: 65178-38677, Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamedan
Postal code
38677-65178
Approval date
2014-03-02, 1392/12/11
Ethics committee reference number
P/16/35/9/4201
Health conditions studied
1
Description of health condition studied
Orthodontic pateints with class II,division 1 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
Patients satisfaction from treatment
Timepoint
4 mounths after beginig of treatment
Method of measurement
Questionarie
Intervention groups
1
Description
Intervention group one: 33 pateints treated with clear twin block functional appliance
Category
Treatment - Devices
2
Description
intervention group two :33 pateints treated with classic 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 Mohammad Karim Soltani
Street address
Postcode: 65178-38677, 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
Postcode: 65178-518, School of Medicine, Shahid Fahmideh Street, Hamadan Hamadan
City
Hamedan
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 Mohammad Karim Soltani
Position
Assistant professor
Other areas of specialty/work
Street address
Postcode: 65178-38677, Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamedan
Postal code
38677-65178
Phone
00898118381059
Fax
+98 81 1838 1085
Email
m.k.soltani@umsha.ac.ir; mksoltani2002@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Mohammad Karil Soltani
Position
Assistant professor
Other areas of specialty/work
Street address
Postcode: 65178-38677, Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamedan
Postal code
38677-65178
Phone
+98 81 1838 1059
Fax
+98 81 1838 1085
Email
m.k.soltani@umsha.ac.irm; ksoltani2002@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Mohammad Karim Soltani
Position
Assistant professor
Other areas of specialty/work
Street address
Postcode: 65178-38677, Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamedan
Postal code
38677-65178
Phone
+98 81 1838 1059
Fax
+98 81 1838 1085
Email
m.k.soltani@umsha.ac.ir; mksoltani2002@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)