aim: Effect of bionator treatment on skeletal and dental changes among class II patients
study design: randomized, single blind, no placebo
inclusion criteria:age 12-9 years; with dental and skeletal Class II malocclusion,
Exclusion criteria: uncooperative children
sample size:17 patients (8 girls and 9 boys)
intervention studied:bionator appliance
intervention time:5-19 mounts
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112525242N1
Registration date:2016-02-20, 1394/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-20, 1394/12/01
Registrant information
Name
Mehdi Rafiei
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4066
Email address
mehdi.rafiei@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-09-21, 1392/06/30
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of bionator treatment on skeletal and dental changes among class II patients
Public title
Effect of bionator treatment on skeletal and dental changes among class II patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 12-9 years; with dental and skeletal Class II malocclusion, Exclusion criteria: uncooperative children
Age
From 84 years old to 81 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
17
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
Islamic Azad University of Isfahan (Khorasgan), Dental School
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Approval date
2013-11-22, 1392/09/01
Ethics committee reference number
23810201900150
Health conditions studied
1
Description of health condition studied
skeletal malocclusion Class II
ICD-10 code
K07.5
ICD-10 code description
Dentofacial functional abnormalities
Primary outcomes
1
Description
malocclusion class II
Timepoint
3-4 weeks
Method of measurement
colis & conveyor
Secondary outcomes
empty
Intervention groups
1
Description
bionitir
Category
Treatment - Devices
2
Description
control
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Mehdi Rafiei
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Isfahan (Khorasgan)
Full name of responsible person
Mehdi Rafiei
Street address
Islamic Azad University of Isfahan (Khorasgan), Dental School
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Isfahan (Khorasgan)
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
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Mehdi Rafiei
Position
Orthodontics/phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street