Comparison of Dimensional changes of upper airway before and after rapid maxillary expansion in children with maxillary constriction evaluated with cone beam computed tomography
Objectives: The aim of this study is to evaluate dimensional changes of upper airway after rapid maxillary expansion via CBCT. Design: stage 2 trial.
setting and conduct: 15 patients refering to Orthodontic department of khorasegan university requiring rapid maxillary expansion due to maxillary transverse deficiency are selected and treated with Hyrax appliances with rapid activation. CBCT images of the patients will be obtained before and 4 months after the Rapid Maxillary Expansion and upper Airway volume,nasal transverse dimensions, angular and distance landmarks will be measured before and 4 months after the treatment.
Participants including major eligibility criteria: Patients with 10 to 15 years old who needs maxillary expansion due to maxillary width deficiency.
Intervention: CBCT images before and 4 month after treatment.
Main outcom measures: Increase of maxillary width followed by upper airway changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070818404N1
Registration date:2014-10-19, 1393/07/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-19, 1393/07/27
Registrant information
Name
Sepideh Dadgar
Name of organization / entity
Azad university of Khorasegan
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6021
Email address
s.dadgar@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-04-19, 1393/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dimensional changes of upper airway before and after rapid maxillary expansion in children with maxillary constriction evaluated with cone beam computed tomography
Public title
Evaluation of Dimensional changes of upper airway after rapid maxillary expansion
Purpose
Health service research
Inclusion/Exclusion criteria
Patients with 10 to 15 years old who needs maxillary expansion due to maxillary width deficiency.
Age
From 10 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
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
Ethical committee of Isfahan University Of Medical Sciences
Street address
Hezar Jirib street
City
Isfahan
Postal code
81745-313
Approval date
2015-02-20, 1393/12/01
Ethics committee reference number
493010
Health conditions studied
1
Description of health condition studied
Maxillary constriction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
palatal width
Timepoint
before and 4 month after rapid maxillary expansion
Method of measurement
cone beam computed tomography
Secondary outcomes
1
Description
upper airway volume
Timepoint
before and 4 month after rapid maxillary expansion
Method of measurement
cone beam computed tomography
Intervention groups
1
Description
2 radiographic images taken before and 4 month after treatment taken with CBCT technique
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontic department of dental faculty of Khorasgan Azad university
Full name of responsible person
Sepideh Dadgar
Street address
East Jay street,Arghavanie boulevard
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Islamic Azad university of Khorasgan
Full name of responsible person
Vahid Esfehanian
Street address
East jay street,Arghavanieh boulevard
City
Isfahan
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,Islamic Azad university of 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 Khorasgan
Full name of responsible person
Soosan Sadeghian
Position
asistant professor
Other areas of specialty/work
Street address
Arghavanie boulevard
City
Isfahan
Postal code
Phone
+98 31 3535 4123
Fax
Email
ssadeghian@khuisf.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Azad university of Khorasgan
Full name of responsible person
Sepideh Dadgar
Position
post-graduate student of orthodontics
Other areas of specialty/work
Street address
Arghavanie boulevard
City
Isfahan
Postal code
Phone
+98 31 3535 4123
Fax
Email
S.dadgar@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)