The purpose of this study is to compare the amount of scar tissue by using two type of vicryl and rapid vicryl in genioplasty surgery.
Design
Randomized Clinical Trial- a parallel study with split-mouth design
Settings and conduct
26 patients undergoing Genioplasty in Alzahra and Kashani teaching hospitals will be included. after performing the osteotomy, suturing the incision line will be performed using Vicryl Rapide and Vicryl suture materials on the right and left sides based on the randomized order.after 4 months, evaluation the scar tissue using the mucosal scarring index will be performed by three maxillofacial surgeons.
Participants/Inclusion and exclusion criteria
all patients undergoing genioplasty for correction of their skeletal deformity are included in this study. any factor causing impaired wound healing and unusual scar formation excludes the patient from the study.
Intervention groups
Intervention group 1: After randomization , the randomization plan is used as follows: "the first suture name is placed on the right side while the second one on the left side of the incision line". Genioplasty is done using Sliding technique. due to the split-mouth design, the sealed envelop related to the patient's ID number is peeled open and the right side of the incision line from the right mandibular canin to the mid-line is sutured with vicryl or vicryl rapide suture as mentioned in the randomization plan
Intervention group2:Genioplasty is done using Sliding technique. due to the split-mouth design the left side of the incision line from the left mandibular canin to the mid-line is sutured with vicryl or vicryl rapide suture as mentioned in the randomization plan
Main outcome variables
the mean score of the mucosal scarring index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131205015665N6
Registration date:2022-09-09, 1401/06/18
Registration timing:retrospective
Last update:2022-09-09, 1401/06/18
Update count:0
Registration date
2022-09-09, 1401/06/18
Registrant information
Name
Milad Etemadi-Shalamzari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1391 3237
Email address
etemadi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Evaluation of scar formation using VICRYL® RAPIDE and VICRYL® suture materials in genioplasty : A Thriple-blinded Randomized Clinical Trial
Public title
Efficacy of Vicryl Rapide suture on the reduction of the scar formation after genioplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients undergoing Genioplasty osteotomy for correction of skeletal deformity
Exclusion criteria:
age less than 18 or more than 40
pre-existing scar in vestibular area or history of surgery in maxillary vestibule
any systemic and chronic disease which can interfere with wound healing process (i.e. diabetes, kidney and liver diseases)
long-term corticosteroid or antibiotic therapy, or immunosuppressor drugs (specially in the last 6 month)
congenital or acquired compromising immune system
dehydration and malnutrition and associated neural defects (especially vitamin C and zinc deficiency)
history of radiotherapy and using cytotoxic drugs
tobacco use and alcoholism
Fitzpatrick skin classification types I, IV, V, VI
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
26
More than 1 sample in each individual
Number of samples in each individual:
2
In each patient, the right half of the incision (from the mandibullar canin to the mid-line) will be sutured with one suture material (vicryl or vicryl rapide based on a randomization plan) and the left half with the other suture material
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization using online computer-based software (http://www.randomization.com) leading to a randomized plan in which the first suture will be used in the right side and the second suture on the left side of the surgery.due to the split-mouth design, the sealed envelop related to the patient's ID number is peeled open and the right side of the incision line from the mandibullar canin to the mid-line is sutured with vicryl or vicryl rapide suture as mentioned in the randomization plan by continuous lock technique and in a tension-free mannerand and the left half with the other suture material.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient: patients are not aware of the exact location of the suture materials and dissociation of suture material is not possible because the apparent feature of them are same .
Outcome assessor: assessors are not aware of the exact location of the suture materials during the examination of the scar tissue.
Investigator: The researcher will not be aware of the exact location of the suture materials and they will be only informed by the surgeons' registrations in the patients' form using "A" and "B" codes for suture materials.
Data analyzer: analyzer won't be aware of the exact location of the suture materials and data is given to him/her coded as "A" and "B".
Placebo
Not used
Assignment
Parallel
Other design features
Split-mouth design: the right half of the incision (from the mandibullar canin to the mid-line) will be sutured with one suture material (vicryl or vicryl rapide based on randomization plan) and the left side with the other suture material.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.469
Health conditions studied
1
Description of health condition studied
mucosal scar in mandibular vestibule after Genioplasty
ICD-10 code
Y81.3
ICD-10 code description
General- and plastic-surgery devices associated with adverse incidents : surgical instruments, materials and devices (including sutures)
Primary outcomes
1
Description
Mean score of mucosal scarring index from 0 to 10
Timepoint
4 months after surgery
Method of measurement
using mucosal scarring index consisting of 5 parts of Width, Height or Contour, Color, Suture mark, and Overall appearance; each range from 0 to 2 scores. For reach patient, 3 surgeons will evaluate the tissue and the mean of scores will be reported for the left and right sides for each patient.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Considering an ID number from 1 to 26 for each patient,After randomization , the randomization plan is used as follows: "the first suture name is placed on the right side while the second one on the left side of the incision line". Genioplasty is done using Sliding technique and The initial cut is perpendicular to mucosa. Then, as muscle is transected, the angle of the cut is altered perpendicular to the bone and continued through the periosteum.At least 5 mm of attached periosteum and muscle are left between the inferior border of the symphysis and the subperiosteal dissection . before suturing the incision line, mentalis mussle each side sutured. due to the split-mouth design, the sealed envelop related to the patient's ID number is peeled open and the right side of the incision line from the right mandibular canin to the mid-line is sutured with vicryl (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) or vicryl rapide (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) suture as mentioned in the randomization plan by continuous lock technique and in a tension-free manner.
Category
Treatment - Other
2
Description
Intervention group2: Considering an ID number from 1 to 26 for each patient,After randomization , the randomization plan is used as follows: "the first suture name is placed on the right side while the second one on the left side of the incision line". Genioplasty is done using Sliding technique and The initial cut is perpendicular to mucosa. Then, as muscle is transected, the angle of the cut is altered perpendicular to the bone and continued through the periosteum.At least 5 mm of attached periosteum and muscle are left between the inferior border of the symphysis and the subperiosteal dissection . before suturing the incision line, mentalis mussle each side sutured. due to the split-mouth design, the sealed envelop related to the patient's ID number is peeled open and the left side of the incision line from the left mandibular canin to the mid-line is sutured with vicryl (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) or vicryl rapide (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) suture as mentioned in the randomization plan by continuous lock technique and in a tension-free manner.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Etemadi Milad
Street address
Al-zahra hospital,Sofe Blvd,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 9273 7130
Email
Alzahra@mui.ac.ir
Web page address
http://Alzahra.mui.ac.ir
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Milad Etemadi
Street address
Kashani hospital ,Ayatollah Kashani St,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 9237 7130
Email
Kashani@mui.ac.ir
Web page address
http://kashani.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansoor Siavash
Street address
Vice-chancellor in research affairs,Isfahan University of Medical Sciences,Hezar jarib St,Isfahan ,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 6836 3881
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Milad Etemadi
Position
Assist professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral and maxillofacial surgery, Dentistry Faculty, Isfahan University of Medical sciences, Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
817467361
Phone
+98 31 9237 8155
Email
Etemadi@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Etemadi-Shalamzari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar-jerib st., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1391 3237
Fax
+98 31 1391 3237
Email
etemadi@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Etemadi Shalamzari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral and maxillofacial Surgery, Dentistry Faculty, Isfahan University of Medical Sciences, Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5581
Email
etemadi@dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There isn’t further information
Study Protocol
Yes - There is 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
Undecided - It is not yet known if there will be 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
Study protocol
When the data will become available and for how long
Starting 6months after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
No other condition
From where data/document is obtainable
Sending request email to 1996.f.baghery@gmail.cm
What processes are involved for a request to access data/document
10 day after sending the request,data will be accessible