Protocol summary

Summary
The purposes of this study are efficiency evaluation of thick wafer in comparison with standard wafer on assessment of maxillary sagittal position during orthognathic surgery. This is a single arm Quasi-experimental trial study, which will be performed on 9 patients with skeletal discrepancy of the jaws, class 2 and 3, who would be referred to oral and maxillofacial surgery clinic of Shariati hospital of Tehran. The inclusion criteria is skeletal discrepancy of the jaws, class 2 or 3, without previous history of orthognathic surgery. The exclusion criteria is the patients who are unwilling to sign the written consent for. In each case, mandibular and maxillary casts would be provided and fixed to the arthiculator. Then model surgery of the patient will begin and maxillary cast separates from the arthiculator base and will be fixed to the arthiculator in 2 mm more anterior than the primary position (0 position). Then maxillary cast will be separated from arthiculator, and fixed to it in 1 mm more anterior than 0 position (a-1 position). Now, a standard wafer and a thick wafer with 5 mm thickness, would be provided. This procedure would be replicated in 2 mm and 3 mm more anterior than 0 position (a-2 position and a-3 position). During the operation, horizontal osteotomy line will be marked on maxillary bone with a bur and a vertical line would be drown on the bone at molar area. Now, lefort 1 osteotomy and maxillary down fracture will be performed. At this time maxilla would be repositioned with the standard wafer for a-1 position, as two segments of the maxilla interconnect at the osteotomy line. Then amount of displacement of vertical line on down fractured maxillary segment from vertical line on the base of the maxilla would be measured. Now, thick wafer for a-1 position will be placed and the same measurement will be performed . This procedure would be repeated with provided wafers in a-2 and a-3 positions, and finally data from this study would be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015032521539N1
Registration date: 2015-05-21, 1394/02/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-21, 1394/02/31
Registrant information
Name
Aref Darvishi
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 26 3351 6152
Email address
aref_darvishi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Self funded
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Quasi experimental study of accuracy comparison of thick wafer with standard wafer, in transferring of sagittal position of maxilla during lefort 1 osteotomy in patients with skeletal discrepancy of the jaws
Public title
Efficiency evaluation of thick wafer in assessment of maxillary position in orthognathic surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: the patients with skeletal discrepancy of the jaws, class 2 or 3, without previous orthognathic surgery Exclusion criteria: the patients who are unwilling to sign the written consent for
Age
From 19 years old to 27 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 9
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd., Tehran
City
Tehran
Postal code
Approval date
2014-10-01, 1393/07/09
Ethics committee reference number
8911250001

Health conditions studied

1

Description of health condition studied
Skeletal discrepancy of the jaw
ICD-10 code
Q65-Q79
ICD-10 code description
Congenital malformations and deformations of the musculoskeletal system

Primary outcomes

1

Description
Amount of displacement of mobilized segment of the maxilla
Timepoint
During the operation of the patient
Method of measurement
based on millimeter

Secondary outcomes

empty

Intervention groups

1

Description
During the operation, after lefort 1 osteotomy, with use of the standard wafer for a-1position, position of the maxillary mobilized segment will be marked on the base of the maxilla, and then this marking will be replicated with thick wafer for a-1 position, and finally distance between these two points will be measured. This procedure will be repeated with provided thick and standard wafers for a-2 and a-3 position. Finally 3 measures will be gained from each patient.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of oral and maxillofacial surgery of Shariati hospital
Full name of responsible person
Aref Darvishi, resident in oral and maxillafacial surgery
Street address
Clinic of oral and maxillofacial surgery, Shariati hospital of Tehran,
City
karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
Vice chancellor for research, Tehran University of Medical Sciences, faculty of dentistry
Full name of responsible person
Vice chancellor for research, Tehran University of Medical Sciences, faculty of dentistry
Position
Vice chancellor for research, Tehran University of Medical Sciences, faculty of dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, North Karegar st., Tehran
City
Tehran
Postal code
Phone
+98 21 8801 5881
Fax
Email
dentistry@tums.ac.ir
Web page address
dentistry.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, faculty of dentistry
Full name of responsible person
Farnush Mohammadi
Position
Oral and maxillofacial surgeon
Other areas of specialty/work
Street address
Department of oral and maxillofacial surgery, Faculty of Dentistry, North Karegar St., Tehran
City
Tehran
Postal code
Phone
+98 21 8801 5950
Fax
Email
dentistry@tums.ac.ir
Web page address
dentistry.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Aref Darvishi
Position
Resident in oral and maxillofacial surgery
Other areas of specialty/work
Street address
Department of oral and maxillofacial surgery, Faculty of Dentistry, North Karegar St., Tehran
City
Tehran
Postal code
Phone
+98 21 8801 5950
Fax
Email
dentistry@tums.ac.ir
Web page address
dentistry.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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