Comparison of accuracy of conventional surgical orthognathic and 3-D printed splints in maxillary orientation
Design
10 candidates for orthognathic surgery are going to be sequentially picked based on their referral time to Tehran Buali hospital if they meet the study inclusion criteria. two interventions (acrylic and 3-d printed splints) are going to be performed on each ones jaw plaster models and the differences between maxilla movements will be measured.eventually each participant will undergo surgery with the guide of 3-d printed splint and postoperative cephalometric values will be compared with predictional ones.
Settings and conduct
the study field is" health care advancement" and the location is Tehran Buali hospital. no blindness is commited.
Participants/Inclusion and exclusion criteria
inclusion criteria: 17-40 Yrs old patients, with dentofacial disharmony as a skeletal abnormality, who are candidates for orthognathic two jaw or maxillary single jaw surgery.
exclusion criteria: patients with systemic comorbidities interfering with surgical process and outcome; candidates for maxillary segmental and mandibular single jaw surgeries.
Intervention groups
intervention is applied by conventional splint and 3-D printed one , and totally twice, for each of 10 participants.
maxillary movements are evaluated on plaster models for both splints and each participant.postoperative radiographic maxillary orientation changes with 3-D printed splint are also going to be measured for each patient in all spacial dimentions.
Main outcome variables
Maxillary movements in spacial directions with each splint ; predictional cephalometric values ; postoperative cephalometric values.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170723035253N2
Registration date:2018-05-31, 1397/03/10
Registration timing:retrospective
Last update:2018-05-31, 1397/03/10
Update count:0
Registration date
2018-05-31, 1397/03/10
Registrant information
Name
Omid Hamzezadeh tofighi
Name of organization / entity
Tehran Islamic Azad University-Dental Faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 1107
Email address
ohtofighi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the accuracy of orthognathic conventional and 3-D printed surgical splints in maxillary position
Public title
Comparison of the accuracy of conventional and 3d printed orthognathic surgical splints in maxillary position
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 17-40 Yrs old.
Patients with dentofacial disharmony, as a skeletal abnormality.
Patients candidated for two jaw or maxillary single jaw orthognathic surgery.
Exclusion criteria:
Patients candidated for maxillary segmental and mandibular single jaw surgery.
Patients with systemic comorbidities interfering with surgical process and outcome.
Cleft lip/palate or craniofacial syndrome patients
Age
From 17 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
two splints, an acrylic and a 3-D printed one are going to be evaluated for each participant.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran azad university dental faculty
Street address
9th. Neyestan, Pasdaran Av.
City
Tehran
Province
Tehran
Postal code
1946853315
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.IAU.DENTAL.REC.1396,3
Health conditions studied
1
Description of health condition studied
3-d printed surgical splint
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
maxillary movements
Timepoint
preoperative and postoperative
Method of measurement
calipper: protractor
Secondary outcomes
1
Description
surgical splints
Timepoint
preoperative and postoperative
Method of measurement
visual
Intervention groups
1
Description
Control group: conventional acrylic splint
Category
Treatment - Devices
2
Description
Intervention group: 3d printed splint
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Buali hospital
Full name of responsible person
Farzin Sarkarat
Street address
Buali hospital, Damavand Ave.
City
Tehran
Province
Tehran
Postal code
1946853315
Phone
+98 21 3331 1107
Fax
+98 21 3331 1108
Email
ohtofighi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzin Sarkarat
Street address
9th Neyestan St., Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853315
Phone
+98 21 2200 6660
Email
Sarkarat@hotmail.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
Omid Hamzezadeh Tofighi
Position
Oral and maxillofacial surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Azad university dental faculty, 9th neyestan St, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853315
Phone
+98 21 2200 6660
Email
ohtofighi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzin Sarkarat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
9th Neyestan St, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853315
Phone
+98 21 2200 6660
Email
sarkarat@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Omid Hamzezadeh Tofighi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853315
Phone
+98 21 2200 6660
Email
ohtofighi@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
Undecided - It is not yet known if there will be a plan to make this available
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