Evaluation of mandibular condyle surface remodeling after orthognathic surgery in patients with Class III deformity Between 1400-1401
Design
Study of remodeling of mandibular condyle surfaces of 20 people between 20 and 40 years old who have Class III deformity and have referred to Bouali and Farhikhtegan Hospital in Tehran for mandibular setback surgery
Settings and conduct
Samples of mandibular setback surgery with BSSO method with or without Lefort I Maxilla surgery located in Bouali and Farhikhtegan Hospital of Tehran Azad University are collected and compared by preoperative and 10 months postoperative CBCTs.
In 3D Demand on software, the right and left condylar areas are isolated and 4 new images are created, which include right and left condyles before and after the operation.
The condylar surfaces examined are the anterior, posterior, medial, and lateral surfaces, and the upper surface, which is compared to its counterpart in pre- and postoperative CBCTs.
Participants/Inclusion and exclusion criteria
Healthy people between the ages of 20 and 40 with Class III deformity without severe facial asymmetry and degenerative joint disease.
Intervention groups
Mandibular setback surgery by BSSO method with or without Lefort I maxillary surgery
Main outcome variables
Remodeling of mandibular condyle surfaces
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211012052741N1
Registration date:2021-10-30, 1400/08/08
Registration timing:prospective
Last update:2021-10-30, 1400/08/08
Update count:0
Registration date
2021-10-30, 1400/08/08
Registrant information
Name
Farbod Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2620 3975
Email address
farbodjafari1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of mandibular condyle surface remodeling after orthognathic surgery in patients with Class III deformity Between 1400-1401
Public title
Evaluation of mandibular condyle surface remodeling after orthognathic surgery in patients with Class III deformity Between 1400-1401
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with class III deformity
Between the ages of 20 to 40
Exclusion criteria:
Severe facial asymmetry
Degenerative joint diseases
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Ethics Committee of the School of Dentistry, Islamic Azad University of Tehran
Street address
No. 9, Neyestan 9, Pasdaran Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.063
Health conditions studied
1
Description of health condition studied
Patients with class III deformity
ICD-10 code
M26.213
ICD-10 code description
Malocclusion, Angle's class III
Primary outcomes
1
Description
Remodeling of mandibular condyle surfaces
Timepoint
Before and 10 month after surgery
Method of measurement
Using CBCT and 3D Demand on software, the right and left mandibular condyle areas are isolated and 4 new images are created, which include right and left condyles before and after the operation.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:20 Healthy people between the ages of 20 and 40 with Class III deformity and without severe facial asymmetry and degenerative joint disease, will undergo mandibular setback surgery with BSSO method, with or without Lefort I Maxilla surgery, which will be carried out in Bouali and Farhikhtegan Hospital of Tehran Azad University. Data of the surgery will be collected and compared by preoperative and 10 months postoperative CBCTs. In "3D Demand on" software, the right and left condylar areas will be isolated and 4 new images will be created, which include right and left condyles before and after the operation. The condylar surfaces that will be examined by the software are 5 surfaces including the anterior, posterior, medial, and lateral surfaces, and the upper surface, which will be compared to its counterpart in pre- and postoperative CBCTs.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali hospital
Full name of responsible person
Farbod Jafari
Street address
Before Imam Ali HWY., Damavand Ave., Imam Hossein Sq.
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8036
Email
booali.hostipal96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No. 9, Neyestan 9, Pasdaran Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Farbodjafari1373@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Farbod Jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 4, Athar street, Nelson Mandela Blvd
City
Tehran
Province
Tehran
Postal code
1966864858
Phone
+98 21 2620 3975
Fax
Email
Farbodjafari1373@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farbod Jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 4, Athar street, Nelson Mandela Blvd
City
Tehran
Province
Tehran
Postal code
1
Phone
+98 21 2620 3975
Fax
Email
Farbodjafari1373@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farbod Jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 4, Athar street, Nelson Mandela Blvd
City
Tehran
Province
Tehran
Postal code
1966864858
Phone
+98 21 2620 3975
Fax
Email
Farbodjafari1373@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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available