“Cephalometric evaluation of dentoalveolar and skeletal changes of upper and lower jaw and pharyngeal airway space changes after growth modification treatments of class III patients in different stages of cervical vertebrae maturation, with Face-mask appliance.”
Evaluation of dentoalveolar-cephalometric changes of the maxillary and mandibular bones and pharyngeal airways following growth-guided treatments of class 2 patients at different stages of the cervical vertebrae by face mask.
Design
A single-blind, interventional study
according to Inclusion, Exclusion criteria patient selected, cephalograms of the two groups (1- face mask and 2- face mask and hyrax device) survey before and after treatment.
Cephalograms are divided into three groups: CS2, CS1 and CS3 according to the stages of skeletal maturation.
Patients' cases reviewed for presence or absence of transverse expansion and expansion protocol
also Age - Type of Care - Sex - Type of intraoral appliance of patients checked
examining the cephalograms of patients before and after face mask treatment alone or with expansion, to determine the effects of this device
Settings and conduct
Shahid Beheshti and Kerman Dental School between 90 - 98 years.
Participants/Inclusion and exclusion criteria
Inclusion:
1. Patient with Class 3 Skeletal Problems due to Maxilla Deficiency
2. The patient has no previous orthodontic/orthopedic treatment
3. no systemic disease
4. No new craniofacial abnormality or congenital defects such as thickening
5. Do not have a temporomandibular joint problem
6. Has never had tonsillectomy or adenoids
7. No active periodontal disease
Exclusion:
1. Congenital malformations in the craniofacial area
2. Missing or unspecified patient records
3. Differences in the shape of the body of the cervical vertebrae, which include trapezoidal, horizontal, square, and vertical rectangles, respectively.
4. The presence or absence of concussion in the lower port C2, C3, and C4
Intervention groups
1-face mask 2- face mask and hyrax expansion device
Main outcome variables
Dentoalveolar cephalometric changes of the maxillary and mandibular bone; Changes of the pharyngeal airway space
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200124046244N1
Registration date:2020-07-04, 1399/04/14
Registration timing:retrospective
Last update:2020-07-04, 1399/04/14
Update count:0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
shekoofeh shaykhian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3243 4895
Email address
shekoofehshaykhian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2019-12-19, 1398/09/28
Actual recruitment start date
2011-09-22, 1390/06/31
Actual recruitment end date
2019-12-20, 1398/09/29
Trial completion date
2019-12-21, 1398/09/30
Scientific title
“Cephalometric evaluation of dentoalveolar and skeletal changes of upper and lower jaw and pharyngeal airway space changes after growth modification treatments of class III patients in different stages of cervical vertebrae maturation, with Face-mask appliance.”
Public title
“Cephalometric evaluation of dentoalveolar and skeletal changes of upper and lower jaw and pharyngeal airway space changes after growth modification treatments.”
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has no grade 3 skeletal problem due to maxillary dysfunction
The patient has no previous orthodontic / orthopedic treatment
No systemic disease
No new craniofacial anomaly or congenital defects such as thickening
Do not have a temporomandibular joint problem
The patient has not had tonsillectomy or adenoids in the past
No active periodontal disease
Exclusion criteria:
Congenital malformations in the craniofacial region
Missing or unspecified patient records
Differences in the shape of the cervical vertebrae, which include trapezoidal, horizontal, square and vertical rectangles, respectively.
The presence or absence of concussion in the lower port C2, C3 and C4
Age
From 8 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
42
Actual sample size reached:
54
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Residents are not aware of the type of treatment performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman Research
Street address
Vice-chancellor for Research and Technology, Ibn Sina Street, Somayyeh (Tahmasb Abad) Kerman, Iran
City
kerman
Province
Kerman
Postal code
7619813159
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.KMU.REC.1398.456
Health conditions studied
1
Description of health condition studied
Class 3 skeletal malocclusion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of dentoalveolar cephalometric - upper and lower jaw bone
Timepoint
Before and after treatment
Method of measurement
Pre- and post-cephalograms of patients are manually performed by an orthodontic resident.
2
Description
and pharyngeal airway space changes
Timepoint
Before and after treatment
Method of measurement
By Auto CAD 2018 software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Face mask group 2- face mask device and hyrax expansion device
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Ali Eskandarizadeh
Street address
Shafa Ave, School of Dentistry - Kerman, Iran
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
dentistryschool@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhrti
Street address
Vice-chancellor for Research and Technology, Ebneh Sina Ave, Somayyeh (Tahmasb Abad), Kerman, Iran
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
kmu_research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
DR Amin Aminian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave, Dental School - Kerman, Iran
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
mfaminian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amin Aminian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave, Dental School - Kerman, Iran
City
keman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
mfaminian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shekoofeh Shaykhian
Position
Orthodontics resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave, Dental School - Kerman, Iran
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
shekoofehshaykhian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
As the result of the data will be published as article , it is not necessary to publish the data file