Comparison of Tensile Strengths of two Absorbable Suture Materials (Chromic gut vs Polyglycolic acid ) in Minor Oral Surgeries
Design
Two arm parallel group randomised trial with non-blind outcome assessment, on 16 patients. Coin toss was used for randomization
Settings and conduct
In this study, 2 types of 4 zero absorbable coated polyglycolate sutures (under the brand name SUPABON from Supa Company, Iran) and Chromic Catgut (under the brand name SUPA CHROMIC from Supa Company, Iran) are used. In this study, 16 patients who need minor oral surgery participate. These patients are randomly divided into two groups of eight. Patients are informed about the research work and informed consent is obtained from them. Chromic gut is used for one group of absorption sutures and Polyglycolic acid suture is used for the other group to suture the edges of the wound. A portion of each suture is cut off before suturing to perform a tensile strength test to determine the amount of tensile strength of the base. This part of the suture, along with the sutures that are removed on the 7th and 10th day after surgery, their tensile strength is measured by the Universal testing machine.
Participants/Inclusion and exclusion criteria
Patients who need minor oral surgery
Intervention groups
In this study, 16 patients who need minor oral surgery participate. These patients are randomly divided into two groups of eight. For one group, chromic gut absorption sutures are used, and for the other group, polyglycolic acid sutures are used to suture the edges of the wound
Main outcome variables
Tensile strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200815048413N1
Registration date:2020-09-20, 1399/06/30
Registration timing:registered_while_recruiting
Last update:2020-09-20, 1399/06/30
Update count:0
Registration date
2020-09-20, 1399/06/30
Registrant information
Name
Mahmood Beyki Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3223 4192
Email address
bghasemi01@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-15, 1399/06/25
Expected recruitment end date
2020-10-16, 1399/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Tensile Strengths of two Absorbable Suture Materials (Chromic gut vs Polyglycolic acid ) in Minor Oral Surgeries
Public title
Comparison of Tensile Strengths of two Absorbable Suture Materials (Chromic gut vs Polyglycolic acid ) in Minor Oral Surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need minor oral surgeries
Exclusion criteria:
Patients who do not return for removing sutures on days 7 and 10 after surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who refer for minor oral surgery are divided into one of two groups based on coin toss
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
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahwaz Jundishapur University of Medical Sciences, Golestan Highway
City
َAhwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.AJUMS.REC.1399.172
Health conditions studied
1
Description of health condition studied
Tensile strength of absorbable Chromic gut suture
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Tensile strength of absorbable polyglycolic acid suture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tensile strength of chromatic gut & polyglycolic acid sutures in Newton
Timepoint
On days 0, 7, 10
Method of measurement
Tensile strength is recorded by Universal testing machine (STM 50 machine from SANTAM Eng.Design.Co. Made in Iran)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For one group is used chromic gut suture (under the brand name SUPA CHROMIC from Supa company, Iran). One section of each suture is cut off before suturing to perform a tensile strength test to determine the amount of tensile strength of the base. This part of the suture, along with the sutures that are removed on the 7th and 10th day after surgery, their tensile strength is recorded by the Universal testing machine.
Category
Treatment - Devices
2
Description
Intervention group: For one group is used Polyglycolic acid suture (under the brand name SUPABON, Supa company, Iran). One section of each suture is cut off before suturing to perform a tensile strength test to determine the amount of tensile strength of the base. This part of the suture, along with the sutures that are removed on the 7th and 10th day after surgery, their tensile strength is recorded by the Universal testing machine.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Jundishapur Dental School, Department of Periodontics
Full name of responsible person
Mahmood Beyki Ghasemi
Street address
Ahwaz School of Dentistry, Jundishapur University of Medical Sciences, Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8426
Fax
+98 61 3320 5320
Email
Bghasemi01@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences and Health Services, Ahvaz University City
City
Ahwaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 2414
Email
iitc@ajums.ac.ir
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
Leyla Golpasand Hagh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Periodontology, School of Dentistry, Jundishapur University of Medical Sciences
City
َAhwaz
Province
Khouzestan
Postal code
6163863943
Phone
+98 61 3337 7360
Email
Golpasand-l@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leyla Golpasand Hagh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Periodontology, School of Dentistry, Jundishapur University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
6163863943
Phone
+98 61 3337 7360
Email
Golpasand-l@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leyla Golpasand Hagh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Periodontology, School of Dentistry, Jundishapur University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
6163863943
Phone
+98 61 3337 7360
Email
Golpasand-l@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available