The comparison of the clinical effects of traditional and clear twin block
Design
clinical trial with two groups and the 60 patients ,randomized with SNOSE method.
Settings and conduct
In this randomized clinical trial ,the clinical effects of traditional twin block and clear twin block will be compared. Sixty patients who need growth modification treatment will be selected and randomly divided into two groups. At the end of the treatment skeletal and dental changes and muscular functions will be examined. The mechanism of clear twin block is the same as traditional twin block but acrylic material is replaced with thermoplastic sheets .Electromyography will be done to measure the muscular function and cephalometric analysis will be done for measurement of skeletal and dental changes and all date will be recorded in the check list. Furthermore a part of treatment results will be checked six months later. We will use spss ver 24 for data analysis. paired t- test will be used for before-after comparison and independent t test will be used for the comparison between the groups.
Participants/Inclusion and exclusion criteria
the patients should be in the growth spurt stage.
the willingness of the patient and parents for the treatment
skeletal class II div 1
the presence of suitable teeth for the retention of the appliance
informed consent of the patient
Intervention groups
traditional twin block
clear twin block
Main outcome variables
improvement in jaw relationship
improvement in muscle function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170723035238N3
Registration date:2021-12-11, 1400/09/20
Registration timing:retrospective
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
ahmad behroozian
Name of organization / entity
tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 33379351
Email address
behrooziana@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-25, 1400/08/03
Expected recruitment end date
2021-11-24, 1400/09/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the comparison of the clinical and muscular effects of traditional twin block andclear twin block:a randomized clinical trial
Public title
the comparison of the effects of traditional twin block andclear twin block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the patients should be in the growth spurt stage.
skeletal class II div 1
informed consent of the patient
the willingness of the patient and parents for the treatment
the presence of suitable teeth for thee retention of the appliance
Exclusion criteria:
lack of the cooperation of the patient in follow up recalls
lack of oral hygiene
lack of the cooperation of the patient in restoration of decayed teeth before beginning of orthodontic treatment
Age
From 11 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
numbered, sealed, opaque envelope (SNOSE)
in this allocation system the researchers use mate envelopes. the number of the envelopes is equal with the number of the patients in each group. then the envelops are gathered in the box .for each patients one envelope will be selected randomly and the group ( case or control ) will be selected in this way.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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 / Azadi st. / gulgasht st. / Central building of Tabriz medical university
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۳۹۱۶۷۳۷
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.TBZMED.REC.1400.730
Health conditions studied
1
Description of health condition studied
skeletal class II
ICD-10 code
M26.212
ICD-10 code description
Malocclusion, Angle's class II
Primary outcomes
1
Description
Correction of jaw relationship
Timepoint
6 months later
Method of measurement
cephalometery
2
Description
improvement in muscle function
Timepoint
1, 3 and 6 month later
Method of measurement
surface electromyography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: clear twin block
Category
Treatment - Devices
2
Description
Intervention group: traditional twin block
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentiistry faculty / Tabriz University of Medical Science / Gulgasht st. / Azadi st. / Tabriz
Full name of responsible person
Ahmad Behroozian
Street address
Tabriz / Azadi st. / gulgasht st. / Central building of Tabriz medical university
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0310
Fax
+98 41 3334 6977
Email
ahmadbehroozian@gmail.com
2
Recruitment center
Name of recruitment center
office, Dr Ahmad Behroozian
Full name of responsible person
Ahmad Behroozian
Street address
unit b,floor 3, eskan medical building, Abresan
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۳۹۱۶۷۳۷
Phone
+98 41 3336 2055
Email
ahmadbehroozian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Behroozian
Street address
Tabriz / Azadi st. / gulgasht st. / Central building of Tabriz medical university
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0310
Email
ahmadbehroozian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Behroozian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz / Azadi st. / gulgasht st. / Central building of Tabriz medical university
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۳۹۱۶۷۳۷
Phone
004133347635
Email
ahmadbehroozian@gmail.com
Web page address
http://www.drbehroozian.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Behroozian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz / Azadi st. / gulgasht st. / Central building of Tabriz medical university
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۳۹۱۶۷۳۷
Phone
+98 41 3334 7635
Email
ahmadbehroozian@gmail.com
Web page address
http://www.drbehroozian.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Behroozian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz / Azadi st. / gulgasht st. / Central building of Tabriz medical university
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۳۹۱۶۷۳۷
Phone
+98 41 3334 7635
Email
ahmadbehroozian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
the results of the study we be published in the scientific journals .
When the data will become available and for how long
2022-5-10
To whom data/document is available
open access
Under which criteria data/document could be used
for researchers in medical sciences
From where data/document is obtainable
one can find the data in the journal which the article will be published in it.
What processes are involved for a request to access data/document
the access will be according to the policy of the journal which the article will be published in it