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A clinical trial to compare suture vs. cyanoacrylate tissue glue for wound closure in mandibular third molars surgery

Protocol summary

Summary
1) Objectives: Randomized, single blind, without placebo control, unicentral, first phase of clinical trial 2) Design: Data were collected using the records of patients admitted to the Department of Oral and Maxillofacial surgery of Ahvaz Jondishapour Dental School during second half of 2014. 12 patients (age range 19 to 25) were enrolled in this study. 3)Setting and conduct: Patients with bilateral mandibular impacted teeth were selected. 4)Participants including major eligibility criteria: no systemic disease,no wound healing disruptive disease,no diabetes, no bleeding disorders, no history of anticoagulant medicines, no use of immunosuppressant drugs, no history of smoking and drinking. 5)Intervention: After simple sampling for odd and even, in the first surgery after removal of right impacted third molar, flap in evens will be closed with suture and odds with the help of adhesive. after 2 weeks the opposite 3rd molar will be removed and suture will be used for wound closure in odds and adhesive for evens. suture will be selected as a group control and adhesives will be compared with them. 6) main outcome measures: assessment of severity of pain, amount of bleeding and wound healing.

General information

Acronym
have not
IRCT registration information
IRCT registration number: IRCT2015050722139N1
Registration date: 2015-06-10, 1394/03/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-10, 1394/03/20
Registrant information
Name
Benika Abbasi
Name of organization / entity
Ahvaz Jondishapur university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 935 918 0832
Email address
abbasi.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Expense of this thesis has been provided by the credit of the approved research project no. GP-93027 and all right of this thesis is reserved for Ahwaz Jondishapur University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare suture vs. cyanoacrylate tissue glue for wound closure in mandibular third molars surgery
Public title
Tissue adhesives for surgical wound closures
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: -After taking panoramic radiography patients with impacted 3rd molar with mesioangular or vertical impaction, vertical class c pell & gregory and anterior posterior class 2 pell & gregory impaction were selected. -Patients must be younger than 25 years old -No systemic disease,no wound healing disruptive disease,no diabetes, no bleeding disorders -No history of anticoagulant medicines, no use of immunosuppressant drugs. -No history of smoking and drinking -No decays on 2nd molar
Age
From 19 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 12
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Randomization: 12 samples will be assigned a unique number. The numbers are placed in a bowl and thoroughly mixed. Then, an unaware researcher selects n numbers. Population members having the selected numbers are included in the sample. for example, the first number is related to the person X and is considered as odd.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Jondishapur university of medical science
City
Ahvaz
Postal code
61357-15794
Approval date
2014-07-02, 1393/04/11
Ethics committee reference number
ajums.REC.1393.202

Health conditions studied

1

Description of health condition studied
Impacted teeth
ICD-10 code
K01
ICD-10 code description
embedded and impacted teeth with abnormal position of such teeth or adjacent teeth

Primary outcomes

1

Description
pain
Timepoint
1,2,3,5,7 days after surgery
Method of measurement
with pain visual analog scale questionnaire

2

Description
bleeding
Timepoint
1,2,3 days after surgery
Method of measurement
with bleeding questionnaire

3

Description
wound healing
Timepoint
first and second weeks after surgery
Method of measurement
oral and maxillofacial surgeon's view

Secondary outcomes

1

Description
patient comfort
Timepoint
first week after surgery
Method of measurement
according to patients' reports

2

Description
sensitivity of soft tissue
Timepoint
first and second weeks after surgery
Method of measurement
evaluated by oral and maxillofacial surgeon

Intervention groups

1

Description
using tissue adhesive 2 ethyl- cyanoacrylate( EPIGLU, Meyer-Haake Co. Germany) for wound closure in intervention group. adhesive was used according to package insert.
Category
Treatment - Surgery

2

Description
in group control suture was used for wound closure.Non absorbable Suture Silk 0/3 was used for wound closure.simple interrupted suture technique used to close wounds. (supasil-3\0 usp- non-absorbable suture- supa medical devices)
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Jondishapur faculty of dentistry
Full name of responsible person
doctor Omid Ghasemzadeh.Assistant Professor
Street address
Department of Oral and Maxillofacial surgery of Ahvaz Dental School
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz University of Medical Sciences
Full name of responsible person
Doctor seyyed Ahmad Hosseini
Street address
Jondishapur university of medical science
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Jondishapur university of medical science
Full name of responsible person
Benika Abbasi
Position
student
Other areas of specialty/work
Street address
Jondishapur university of medical science
City
Ahvaz
Postal code
Phone
+98 935 918 0832
Fax
Email
Abbasi.b@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jondishapur university of medical science
Full name of responsible person
Doctor Omid Ghasemzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Jondishapur faculty of dentistry
City
Ahvaz
Postal code
Phone
+98 61 3391 6104
Fax
Email
ghasemzadeho@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jondishapur university of medical science
Full name of responsible person
Benika Abbasi
Position
student
Other areas of specialty/work
Street address
Jondishapur faculty of dentistry
City
Ahvaz
Postal code
Phone
00
Fax
Email
abbasi.b@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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