Effects of preoperative imaging of inferior alveolar nerve canal with Cone Beam CT on neurosensory dysfunction following bilateral sagittal split ramus osteotomy in mandibular setback.
The purpose of this study is to evaluate the relationship of imaging of the IAN canal with CBCT before surgery and neurosensory dysfunction after Bilateral Sagittal Split Ramus Osteotomy. In this clinical trial we will study 40 patients with mandibular prognathism which needed mandibular setback surgery. Plain radiographs included of orthopantograms and lateral cephalograms will take from all patients. In the study group we will take CBCT from the both sides of the ramus and mandibular body to the region of second molar . Surgical technique in all patients is BSSO with the Obwegeser-Dal Pont technique and modification of Hunsuck. Evaluation of neurosensory function of the IAN will be done subjective with a questioner of 5 point scaling after one week, 3 weeks, 3 months, 6 months and 12 months after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052217798N1
Registration date:2014-08-07, 1393/05/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-07, 1393/05/16
Registrant information
Name
Hamidreza Mahaseni Aghdam
Name of organization / entity
Tehran Azad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 6440
Email address
dr_hamid_mahaseni@irimc.org
Recruitment status
Recruitment complete
Funding source
Tehran Azad University of Medical Sciences
Expected recruitment start date
2014-06-06, 1393/03/16
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of preoperative imaging of inferior alveolar nerve canal with Cone Beam CT on neurosensory dysfunction following bilateral sagittal split ramus osteotomy in mandibular setback.
Public title
Effects of preoperative imaging of lower jaw with bone scan on neurosensory dysfunction of the lip following mandibular surgery for setback
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:patients with mandibular prognathism; movement lower than 7 millimeter; no difference in third molar relationship
exclusion criteria: jaw asymmetry; pathologic condition related to inferior alveolar nerve; history of previous jaw surgery; neurosensory disturbances; medical conditions with systemic neuropathy; need for genioplasty.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
local board of ethics and research method of Azad University of Medical Science
Street address
pasdaran street
City
tehran
Postal code
Approval date
2013-09-22, 1392/06/31
Ethics committee reference number
p/214/d
Health conditions studied
1
Description of health condition studied
neurosensory dysfunction of inferior alveolar nerve after bilateral sagittal split ramus osteotomy
ICD-10 code
ICD-10 code description
2
Description of health condition studied
inferior alveolar neurosensory dysfunction
ICD-10 code
G50.9
ICD-10 code description
Disorder of trigeminal nerve, unspecified
Primary outcomes
1
Description
dysfunction of inferior alveolar nerve
Timepoint
day 7 and months 1, 3, 6, 12
Method of measurement
subjective by queationer ( five point scaling)
Secondary outcomes
empty
Intervention groups
1
Description
intervention: we will take Cone Beam CT imaging from inferior alveolar nerve canal before surgery.
Category
Prevention
2
Description
control group: we will take panoramic and lateral cephalometry and posterior anterior cephalometry before surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali hospital
Full name of responsible person
hamidreza mahaseni aghdam
Street address
damavand street
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azad University of Medical Sciences
Full name of responsible person
Azad University of Medical Sciences
Street address
Buali Hospital, Damavand street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran Azad University of Medical Sciences,
Full name of responsible person
Hamidreza Mahaseni Aghdam
Position
resident
Other areas of specialty/work
Street address
Damavand street, Buali hospital
City
Tehran
Postal code
Phone
+98 21 3331 1106
Fax
Email
dr_hamid_mahaseni@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Azad University of Medical Sciences
Full name of responsible person
Hamidreza Mahaseni Aghdam
Position
resident
Other areas of specialty/work
Street address
Buali hospital, Damavand street
City
Tehran
Postal code
Phone
+98 21 3331 1106
Fax
Email
dr_hamid_mahaseni@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Azad University of Medical Sciences
Full name of responsible person
Hamidreza Mahaseni Aghdam
Position
resident
Other areas of specialty/work
Street address
Buali hospital
City
Tehran
Postal code
Phone
00
Fax
Email
dr_hamid_mahaseni@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)