Incidence of Inferior Alveolar Nerve (IAN) disturbance in Bilateral Sagittal Split Osteotomy (BSSO) in skeletal cl. II and cl. III patients by piezoelectric procedure as compared with conventional procedure.
The effects of conventional and piezoelectric surgery on incidence of Inferior Alveolar Nerve ( IAN) disturbance in Bilateral Sagittal Split Osteotomy (BSSO)
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Skeletal cl. 2 and 3 patients who are candidate for BSSO surgery in the Bouali hospital are involved in this study. Piezoelectric and conventional osteotomies are going to be carried out on each side of the mandible by the same specialist. The function of sensory nerve (IAN) is going to be evaluated by 4 following tests: 1. light touch test 2. pin prick test 3. two point discrimination test 4- two moving point discrimination test, before surgery and post-operatively (7 days, 1, 3 months). Patients and examiners are blinded to the applied procedure which is allocated to each side of the mandible.
Participants/Inclusion and exclusion criteria
- Skeletal cl. II and cl. III patients who are candidate for BSSO (including criteria)
- Patients who had experienced maxillofacial surgery ( excluding criteria)
- Patients who had any kind of systemic disease ( excluding criteria)
Intervention groups
- Conventional osteotomy is a procedure in which burs and saws are used for cutting mandibular bone
- Piezoelectric osteotomy is a procedure in which piezoelectric is used for cutting mandibular bone .
Main outcome variables
Inferior Alveolar Nerve disturbance following BSSO surgery: Any neurosensory changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039633N1
Registration date:2018-06-01, 1397/03/11
Registration timing:retrospective
Last update:2018-06-01, 1397/03/11
Update count:0
Registration date
2018-06-01, 1397/03/11
Registrant information
Name
Vahid Mesgarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4570
Email address
v_mesgarzadeh@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2018-06-30, 1397/04/09
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2018-05-10, 1397/02/20
Trial completion date
empty
Scientific title
Incidence of Inferior Alveolar Nerve (IAN) disturbance in Bilateral Sagittal Split Osteotomy (BSSO) in skeletal cl. II and cl. III patients by piezoelectric procedure as compared with conventional procedure.
Public title
Assessment of the incidence of Inferior alveolar nerve (IAN) disturbance in both conventional and piezoelectric procedure in Bilateral Sagittal Split Osteotomy ( BSSO).
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Skeletal cl. II and cl. III patients that are candidate for BSSO surgery (BSSO : Bilateral Sagittal Split Osteotomy)
Exclusion criteria:
History of previous maxiofacial surgery
History of systemic diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
Bilateral Sagittal split Osteotomy in Mandible
Actual sample size reached:
10
More than 1 sample in each individual
Actual sample size in each individual:
2
Bilateral Sagittal split Osteotomy in Mandible
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were selected by envelops shuffling simple randomization for each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Just as the patients, the examiners of the mentioned tests which are going to be carried out will be blinded to the type of the applied procedures (piezoelectric or conventional)
Other intraoperative and postprocedural complications and disorders of nervous system
Primary outcomes
1
Description
light touch sensation
Timepoint
Before intervention, and 7 , 30 and 90 days after intervention
Method of measurement
Visual
2
Description
Pin-Prick test ( Needle test )
Timepoint
Before intervention, and 7 , 30 and 90 days after intervention
Method of measurement
Visual
3
Description
Weber Test ( Two point discrimination)
Timepoint
Before intervention, and 7 , 30 and 90 days after intervention
Method of measurement
Visual
4
Description
moving 2 point discrimination
Timepoint
Before intervention, and 7 , 30 and 90 days after intervention
Method of measurement
Visual
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: BSSO surgery through piezoelectric procedure will be performed on one side of the mandible of 10 patients randomly by "Piezosurgery"; Mectron Medical Technology, Crasco, Italy. In all cases, the setting will be "cortical bone" and in accordance with the developer's recommendations. The water pump will be set at level 5 , which equals 60 mL per minutes.
Category
Treatment - Surgery
2
Description
Control group: BSSO surgery through conventional method will be performed by the means of burs and saws on one side of the mandible of 10 patients randomly.
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
Hassan Mesgari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 16, Kamkar Alley, W. Janbazan Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1636617731
Phone
+98 21 7726 6064
Fax
+98 21 7726 6064
Email
kmesgari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Mesgari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 16, Kamkar Alley, W. Janbazan Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1636617731
Phone
+98 21 7726 6064
Fax
+98 21 7726 6064
Email
kmesgari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Mesgari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 16, Kamkar Alley, W. Janbazan Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1636617731
Phone
+98 21 7726 6064
Fax
+98 21 7726 6064
Email
kmesgari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All of the information are potentially accessible after making unknown personal identities.
When the data will become available and for how long
Access will be allowed within 6 months after publishing
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
In any individual case please contact correspond writer .
From where data/document is obtainable
ِDr. Vahid Mesgarzadeh :
00989121302563
V_mesgarzadeh@dentaliau.ac.ir
Dr. Hassan Mesgari :
00989126216965
kmesgari@gmail.com
What processes are involved for a request to access data/document
First an E-mail should be sent to the correspond writer , after evaluating the request in the research committee , approved information will be given to the requester.