A Comparative study to assess feasibility of computer assisted designed and fabricated surgical guides in sagittal split osteotomy vs. conventional sagittal split osteotomy.
To make a comparative study between computer designed and manufactured surgical guide assisted sagittal split osteotomy of mandibular ramus and conventional sagittal split osteotomy of ramus.
Design
A randomized triple blinded clinical trial study is designed to compare computer designed and fabricated surgical guide assisted sagittal split osteotomy and conventional sagittal split osteotomy.
The study will be conducted on patients that will be visited at Oral and Maxillofacial Surgery Department of Sina Hospital, Tehran University of Medical sciences, Tehran, Iran.
Settings and conduct
The entire patients who have sagittal split osteotomy in their treatment plan will be included this the study .The study subjects are recruited depending on their treatment plan from clients visited at Oral and Maxillofacial Surgery Department of Sina Hospital (Tehran/ Iran). In this study the trial participant, surgeon who will assess the inferior alveolar nerve neurosensory disturbance during follow and statistician will be blinded. they will not know which side is treated conventionally or with the assist of surgical guide..
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 35.
Patients who have sagittal split osteotomy in their treatment plan.
Exclusion criteria:
History of trigeminal neurosensory disturbance.
If genioplasty is included in treatment plan.
History of diabetic, hypertension and kidney failure.
those unwilling to sign informed consent form.
Intervention groups
We have two study groups in this trial:
1. The control group- are side of the mandible that will be treated with conventional sagittal split osteotomy.
2. The intervention group: The side of the mandible that will be treated by sagittal split osteotomy that will be assisted by computer designed and manufactured surgical guide.
Main outcome variables
The inferior alveolar nerve neurosensory disturbance
Duration of osteotomy
. Inferior alveolar nerve position after osteotomy
. unfavorable fracture of mandible during osteotomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020601N2
Registration date:2018-02-10, 1396/11/21
Registration timing:registered_while_recruiting
Last update:2018-02-10, 1396/11/21
Update count:0
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2473
Email address
aj-abbasi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2018-03-17, 1396/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study to assess feasibility of computer assisted designed and fabricated surgical guides in sagittal split osteotomy vs. conventional sagittal split osteotomy.
Public title
surgical guide in jaw surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-35 years.
Patients that has Mandibular sagittal split osteotomy in their treatment plan using virtual surgical planningit osteotomy in their treatment plan using virtual surgical planning
Exclusion criteria:
The patients with a history of Trigeminal nerve Neurosensory disturbance
If genioplasty is included in treatment plan
Have medical condition associated with neuropathy (like Diabetic, Hypertension and Kidney problem
Those unwilling to sign informed consent
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
9
Randomization (investigator's opinion)
Randomized
Randomization description
We will have two study group, the side of mandibular ramus that will be treated by convention osteotomy (can be right or left) and the side that will be treated using the computer designed and manufactured surgical guide of same patient (the other side). For every patient the side of mandibular ramus will be selected by simple random sampling technique (tossing coin). The coin tossing will be used twice to select the side of mandible (right or left) and types of technique (surgical guide assist or conventional)
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study the participant, the outcome assessor and statistician will be blinded, they will not know what treatment is used for which side. The treatment will be registered using a code known only to investigator.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Vice Chancellor for Research
1. Neurosensory disturbance will be assessed at second week, first month and three month after operation.
Method of measurement
A. Quantitative neurosensory testing lower lip and chin 1. Direction of brush stroke using cotton 2.Two point discrimination using needle 3.Tactile threshold using Semmes–Weinstein (SW) monofilament . 4. Temperature awareness by using a tube filled hot water or ice B. Subjective neurosensory testing using a visual analogue scale (VAS).
Secondary outcomes
1
Description
Duration of osteotomy
Timepoint
Intraoperative
Method of measurement
minute
2
Description
unfavorbale fracture
Timepoint
intraoperative
Method of measurement
yes/ no
Intervention groups
1
Description
Intervention group: The Mandibular ramus side for which computer assisted designed and fabricated surgical guide will be used will intervention group. y
Category
Treatment - Surgery
2
Description
Control group: The side of Mandible that will be treated with conventional sagittal split osteotomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital, Oral And Maxillofacial Surgery Ward
Full name of responsible person
Dr. Amir Jalal Abbasi
Street address
Sina Hospital Oral and Maxillofacial surgery ward, Block -5 Imam Khomeini St. Tehran, 11367469911, I.R Iran
City
Tehran
Province
Tehran
Postal code
11367469911
Phone
+98 21 0216 3120
Email
Aj-abbasi@tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
International Campus - Tehran University of Medical Sciences Vice Dean for reasearch Affairs
Full name of responsible person
Mr. Izadyar
Street address
Office of Vice-President for Research Affairs, Number 124 , Baradaran-e-Mozaffar St.,Dameshgh St., Vali-e Asr Ave., Tehran 3439123900, Iran
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8890 8924
Fax
+98 21 8890 8689
Email
b-izadiyar@farabi.tums.ac.ir
Grant name
Fund for thesis of post graduate international student
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Campus - Tehran University of Medical Sciences Vice Dean for reasearch Affairs
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
Tehran University of Medical Sciences
Full name of responsible person
Shimelis Megersa Gema
Position
Resident of Oral and Maxillofacial surgery
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Sina Hospital Oral and Maxillofacial Surgery Ward, block -5 Imam Khomeyni St., 31 Shahrivar Sq. , Tehran 1136746911 ,Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6701 0419
Email
megersagema@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Amir Jalal Abbasi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Speciality in Oral and Maxillofacial Surgery
Street address
Sina Hospital, Oral and Maxillofacial Surgery Ward Block-5 Imam Khomeini St., 31 Shahrivar Sq. , Tehran,1136746911 ,Iran
City
Tehran
Province
Tehran
Postal code
113674691
Phone
+98 216701041
Email
Aj-abbasi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
International Campus- Tehran University of Medical Sciences
Full name of responsible person
Shimelis Megersa Gema
Position
Resident of Oral and Maxillofacial surgery
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences Office of Vice-President for Educational Affairs, Number 124, Baradaran-e Mozafar St. Dameshgh St., Vali-e Asr Ave., Tehran 3439123900 Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6701 0419
Email
megersagema@razi.tums.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
We do not have a data to share
When the data will become available and for how long
We are responsible to share our finding till it will be published as an article on journal.
To whom data/document is available
In cases an academician or academic institution requested to use the finding of this work we are ready to share
Under which criteria data/document could be used
We do not have different criteria
From where data/document is obtainable
Principal investigator
What processes are involved for a request to access data/document
The person or academic institution who want to access this data, will be confirmed that they are requesting the data for academic purpose before sharing.