Comparing effect of tissue adhesive and silk suture for closure of surgical wound after removal of impacted mandibulae third molar:clinical and histologic
Design
Two arm parallel group randomised trial without blinding and Simple randomizatio by Random number table and target sample size:40
Settings and conduct
People with two impacted mandibular third molar will be chosen in dental school.After simple randomization as even and odd,In the first surgery, after the removal of the third molar tooth,the flap of right side will be closed in the evens by suturing and in odds by tissue adhesive and After a week, a biopsy will be performed from surgery site.After more than 2 weeks,The third molar of the opposite side will be removed and Sutures will be used for close the flaps of odds and tissue adhesive will be used to close the flaps of evens and After a week, a biopsy will be performed from surgery site.Sutures as control group will be compared with tissue adhesive as intervention group.
Participants/Inclusion and exclusion criteria
Inclusion critria:
All subjects of 18 years and above with mesio-angularly impacted mandibular third molar
Subjects whitout known systemic disease such as bleeding dyscrasia and immunosuppression
Subjects not allergic to the drugs or anaesthetic agents in the surgical protocol
Subjects with good oral hygiene
Subjects who are non-smokers
Exclusion criteria:
Subject with severe caries of the second molar teeth
Subject between the age of 18 & 25 who have vertical class 1 and level A pell & gregory classification impaction in third molar teeth
Intervention groups
Intervention group: cyanoacrylate tissue adhesive will use in intervention group for wound closure.
Control group: Silk suture will use in control group by simple interrupted suture techniqe.
Main outcome variables
Pain,wound dehiscence,vascularity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191030045286N1
Registration date:2020-05-12, 1399/02/23
Registration timing:retrospective
Last update:2020-05-12, 1399/02/23
Update count:0
Registration date
2020-05-12, 1399/02/23
Registrant information
Name
mahsa farokhnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5234 3015
Email address
farokhnia.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Silk Sutures and Tissue Adhesives for wound closure of Impacted Third Molar Teeth surgery: Clinical and Histological Evaluation
Public title
Investigation of effects of tissue adhesive on Impacted Third Molar Teeth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All subjects of 18 years and above with mesio-angularly impacted mandibular third molar
Subjects whitout known systemic disease such as bleeding dyscrasia and immunosuppression
Subjects not allergic to the drugs or anaesthetic agents in the surgical protocol
Subjects with good oral hygiene
Subjects who are non-smokers
Exclusion criteria:
Subject with severe caries of the second molar teeth
Subject between the age of 18 & 25 who have vertical class 1 and level A pell & gregory classification impaction in third molar teeth
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
After impacted mandibular third molar surjery,one side will be closed with tissue adhesive and the other side will be closed with silk suture
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simply individual and is done by random number table,even numbers are for group A (suture) and odd numbers are for group B (tissue adhesive).We close our eyes and select the number by our finger,If the even number is selected, we close the wound of right side of the jaw with sutures and if odd number is selected,we close the wound of that side of the jaw with tissue adhesive.
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
Ahvaz Jondishapur university of medical science
Street address
Jondishapur university of medical science,Esfand St.,farvardin Ave.,Glestan
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-07-27, 1398/05/05
Ethics committee reference number
IR.AJUMS.REC.1398.340
Health conditions studied
1
Description of health condition studied
Impactd teeth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
pain
Timepoint
1,3,7 days after surgery
Method of measurement
by pain Visual Analogue Scale
2
Description
Wound dehiscence
Timepoint
1,3,7 days after surgery
Method of measurement
by visual inspection and by gentle probing with a williams probe
3
Description
vascularity
Timepoint
7days after surgery
Method of measurement
By microscope
Secondary outcomes
1
Description
Swelling
Timepoint
Befor surgery and 1,3,7 days after surgery
Method of measurement
Average of tragus to pogonion,tragus to commissure and external canthus to gonion
2
Description
Trismus
Timepoint
Before surgery and 1,3,7 days after surgery
Method of measurement
Maximum space between mesial and incisal edge of central teeth of maxilla and mandible
3
Description
Bleeding
Timepoint
1,3,7days after surgery
Method of measurement
Visual Analogue Scale
4
Description
Wound infection
Timepoint
1,3,7 days after surgery
Method of measurement
Based on purulent discharge from the surgical site
5
Description
Wound closure time
Timepoint
during surgery
Method of measurement
Recording by using a calibrated stop watch
6
Description
Inflammatory cell infiltration
Timepoint
7days after surgery
Method of measurement
By microscope
7
Description
Fibroblastic activity
Timepoint
7days after surgery
Method of measurement
By microscope
Intervention groups
1
Description
Intervention group: 2-ethyl-cyanoacrylate tissue adhesive(EPIGLU,Meyer-Haake Co.Germany) will be used in intervention group for surgery wound closure.Tissue adhesive will be used based on the instructions on the package.
Category
Treatment - Surgery
2
Description
Control group: Non-Absorbable 3/0 silk suture will be used in control group by simple interrupted suture techniqe for surgery wound closure.(SUPASIL Non-Absorbable 3/0 braided silk suture,SUPA MEDICAL DEVICES,Iran)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school,Ahvaz University of Medical Science
Full name of responsible person
Shahrokh Raisian
Street address
Oral and Maxillofacial surgery department of Ahvaz dental school,dental school,Dey St.,Farvardin Ave.,Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4114
Email
farokhnia.ma@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.mohammad badvi
Street address
Jondishapoor university of medical science,Esfand St.,Farvardin Ave.,Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
itc@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
Mahsa Farokhnia
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental school of Jondishapoor uiversity,Dey St.,Esfand Ave.,Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 990 191 8808
Email
farokhnia.ma@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahrokh Raisian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school of Jondishapur university,Dey St.,Farvardin Ave.,Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 916 111 2507
Email
raisianshahrokh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Farokhnia
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental school of Jondishapur university,Dey St.,Farvardin Ave.,Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 990 191 8808
Email
farokhnia.ma@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