Investigation of the effect of Sulcular incision on Upper Lip height, Nasolabial angle, height of Incisor teeth crown & Alar base widening
Design
This study perform using prospective randomized clinical trial. The studing population include patients aged 18 to 31 years (mean age 21.8) who undergo LeFort I maxillary advancement with or without impaction. In these randomly select people, salcular incision made to access the maxillary bone, and soft tissue variations measure and compare before and 12 months after the surgery. According to similar studies in this regard, the number of samples for salcular incision in Lefort I osteotomy set at 20 people. Using Minitab softwarewith 90% test power, the number of patients require for the study was determine.
Settings and conduct
This study will be performed on eligible patients in Imam Khomeini Hospital and private hospitals in Ahvaz. In this study, 20 patients who underwent preoperative orthodontic treatment and are ready for Lefort I orthognathic orthognathic surgery will be randomly selected and enrolled in the study.
Surgical treatment plan for orthognathic surgery process of these patients will be Lefort I adjuvant osteotomy surgery alone or with maxillary implantation using salcular incision.
Participants/Inclusion and exclusion criteria
Patients who candidate for maxillary advancement lefort I osteotomy with or without impaction does enter to this study; Patients with lip & palate cleft, old midface fracture, thin gingiva biotype does not enter to this study.
Intervention groups
We have one intervention group in which we will use soft tissue sulcular incision. Before and one year after surgery, the size of the upper lip, the display of the maxilla incisor and the nasolabial angle will be investigated.
Investigation of the effect of Sulcular incision on the surrounding soft tissue in Lefort I Osteotomy.
Public title
Investigation of the effect of Sulcular incision in Lefort I Osteotomy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who candidate for Advancement Lefort I Osteotomy with or without Impaction
Exclusion criteria:
Patients with Lip & Palate cleft
Patients with old Midface fracture
patients with thin biotype Gingiva
Age
From 18 years old to 32 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
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 Ahvaz Jundi Shapour University of Medical Sciences
Street address
Ahvaz University,Dey Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-08-21, 1398/05/30
Ethics committee reference number
IR.AJUMS.REC.1398.305
Health conditions studied
1
Description of health condition studied
investigate for soft tissue changes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Upper lip length from subnasale to ostomion
Timepoint
The variables are measured before surgery and 12 months after surgery.
Method of measurement
Caliper marked by GB-19001,mitutoyo,Japan
2
Description
Nasolabial angle in the area between the columela and upper lip
Timepoint
The variables are measured before surgery and 12 months after surgery.
Method of measurement
Caliper marked by GB-19001,mitutoyo,Japan
3
Description
incisor crown length from sulcus
Timepoint
The variables are measured before surgery and 12 months after surgery.
Method of measurement
Caliper marked by GB-19001,mitutoyo,Japan
4
Description
Alarbase widening by measuring the distance between the alars
Timepoint
The variables are measured before surgery and 12 months after surgery.
Method of measurement
Caliper marked by GB-19001,mitutoyo,Japan
Secondary outcomes
empty
Intervention groups
1
Description
It consists of a group of 20 people who will undergo lefort 1 maxillary advancement osteotomy with or without impaction. In this group, sulcular incision method will be used.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
shahrokh raeesian
Street address
Emam Khomeini Hospital,24 Meters AVE.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
dr_stellar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Badavi Mohammad
Street address
Ahvaz University,Golestan Blvd,Dey Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
dr_stellar @yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Raeesian Shahrokh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ahvaz University,Golestan Blvd,Dey Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
dr_stellar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Raeesian Shahrokh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ahvaz University,Golestan Blvd.,Dey Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
dr_stellar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Akhtari Marzie
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ahvaz University,Golestan Blvd. ,Dey Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
009833362414
Email
dr_stellar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
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
Part of the data, which includes soft tissue changes and the amount of impact and adjudication, is published
When the data will become available and for how long
1399
To whom data/document is available
It will be accessible to everyone
Under which criteria data/document could be used
For more statistical analysis and comparison for longer follow-up
From where data/document is obtainable
For more information, you can contact Dr. Marzieh Akhtar with the following email
dr_stellar@yahoo.com
What processes are involved for a request to access data/document