Comparison of the effect of suture application, with and without cyanoacrylate adhesive on pain and bleeding of intra-oral surgical wounds in patients with bilateral surgery indication in one jaw
Comparison of the effect of suture with and without cyanoacrylate adhesive on pain and bleeding in intraoral surgeries in the department of surgery, Faculty of Dentistry, Islamic Azad University, 2017-2018
Design
Clinical trial with control group, community based and pragmatic, with parallel groups, including 40 cases.
Settings and conduct
Oral surgeries were performed by a resident in the department of surgery of the faculty of dentistry, Islamic Azad University, Tehran. At one side of the mouth, cyanoacrylate adhesive was placed on the wound, and on the other side of the mouth the same surgery was performed and surgical wound was closed by suture. The severity of pain and bleeding was recorded by the patients in the first four days after surgery.
Participants/Inclusion and exclusion criteria
The inclusion criterias of this study included the need for bilateral surgery in upper or lower jaws; and the consent of the patient to the cases mentioned in the consent form.
The exclusion criterias of this study included the presence of systemic diseases; disinterested and unmotivated patient; patients under the age of 16; Pregnant and lactating patients; patients with hypersensitivity to cyanoacrylate adhesive and patients who, after oral surgery, did not need suture and cyanoacrylate adhesive.
Intervention groups
In the control group, the wound was closed by suturing. In the case group, wound was closed by suturing and then two layers of cyanoacrylate adhesive was applied.
Main outcome variables
Pain; bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180623040205N1
Registration date:2018-08-20, 1397/05/29
Registration timing:retrospective
Last update:2018-08-20, 1397/05/29
Update count:0
Registration date
2018-08-20, 1397/05/29
Registrant information
Name
Bahareh Moinee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2255 4624
Email address
bm1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-14, 1396/11/25
Expected recruitment end date
2018-05-17, 1397/02/27
Actual recruitment start date
2018-02-14, 1396/11/25
Actual recruitment end date
2018-05-17, 1397/02/27
Trial completion date
empty
Scientific title
Comparison of the effect of suture application, with and without cyanoacrylate adhesive on pain and bleeding of intra-oral surgical wounds in patients with bilateral surgery indication in one jaw
Public title
The effect of suture with cyanoclastic adhesive on pain and bleeding of surgical wounds
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
bilateral surgery indication in upper or lower jaw
The consent of the patient with the items listed in the consent form.
Exclusion criteria:
The presence of any systemic disease
Disinterested and unmotivated patients
Patients under the age of 16
Pregnant and lactating patients
Patients who are hypersensitive to the composition of cyanoacrylate adhesives
Patients who do not need suture and cyanoacrylate adhesive after oral surgery
Age
No age limit
Gender
Both
Phase
3
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
On one side of the jaw, the suture was placed alone and on the other side, cyanoacrylate adhesive and sutures were used.
Actual sample size reached:
40
More than 1 sample in each individual
Actual sample size in each individual:
2
On one side of the jaw, the suture was placed alone and on the other side, cyanoacrylate adhesive and sutures were used.
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Dental School, Tehran Islamic Azad University
Street address
No.26, Latii Ave., Ekhtiyariye Sq.
City
Tehran
Province
Tehran
Postal code
1959874513
Approval date
2017-11-12, 1396/08/21
Ethics committee reference number
IR.IAU.DENTAL.REC.1396,29
Health conditions studied
1
Description of health condition studied
Impacted teeth
ICD-10 code
K01
ICD-10 code description
Embedded and impacted teeth
Primary outcomes
1
Description
Degree of wound pain after surgery
Timepoint
The first, second, third, and fourth days after surgery
Method of measurement
Visual Analogue Scale 0-9
2
Description
Degree of wound bleeding after surgery
Timepoint
The first, second, third, and fourth days after surgery
Method of measurement
classification of the bleeding in 5 spectra: no bleeding, oozing, accidental low bleeding, continues low bleeding and eventually massive continues bleeding
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, after the surgical wound was closed using sutures, two layers of PeriAcryl 90-HV cyanoacrylate adhesive with the n-butyl and 2-octyl cyanoacrylates formula made by GLUSTITCH INC Factory were applied on the sutures. The adhesive was used based on the instructions on the package.
Category
Treatment - Surgery
2
Description
In the control group, sutures were used for closing the wound. For this purpose, non-absorbable silk thread 3.0 was used. The simple interrupted stitch method was used for closing the wound. (supasil- 3.0 usp- non-absorbable suture- supa medical devices)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Surgery, Faculty of Dentistry, Azad University of Medical Sciences, Tehran, Iran
Full name of responsible person
Bahareh Moinee
Street address
No.4, 10th Neyestan Ave., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2276 3432
Email
bm1369@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Arash Azizi
Street address
No.4, 10th Neyestan Ave., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2276 3432
Email
bm1369@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Bahareh Moinee
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.26, Latifi Ave., Ekhtiyariye Sq.
City
Tehran
Province
Tehran
Postal code
1959874513
Phone
+98 21 2255 4624
Email
bm1369@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Bahareh Moinee
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.26, Latifi Ave., Ekhtiyariye Sq.
City
Tehran
Province
Tehran
Postal code
1959874513
Phone
+98 21 2255 4624
Email
bm1369@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Bahareh Moinee
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.26, Latifi Ave., Ekhtiyariye Sq.
City
Tehran
Province
Tehran
Postal code
1959874513
Phone
+98 21 2255 4624
Email
bm1369@gmail.com
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