Protocol summary

Summary
The Aim is to investigate the effect of Vicryl and Vicryl plus sutures on wound situation after lower jaw impacted third molars surgery upon which to show with choosing proper suture problems will be decreased after surgery. Design: double blind clinical control trial, randomized controlled and split mouth will be done; and the double blind for patients and evaluator has been implemented. Randomization: In each patient, to suture by Vicryl or Vicryl Plus, the Coin tossing has been used to determine which side of the jaw has to be in control (Vicryl) or case (Vicryl Plus) group. All patients who have indication for impacted tooth extraction of mandible in two sides of the jaw, by declaring their agreement to cooperate with this plan, will be examined. Methods: This study will be done on 20 person (40 sample) and each side of patients’ mandible will be divided into experimental group (Vicryl plus) and control group (Vicryl); in both experimental and control groups the wisdom tooth anesthetized by surgeon with two (Lidocaine 2%) carpools then the impacted wisdom tooth will be extracted; and after suturing, post-operative instructions will explained to patient orally; and also Gelofen 400 mg PO. every 6 hours will prescribed. To recorde the index of the effect of sutures on pain level with patient coordination after surgery, in different times as 12,24 and 72 hours, patient will called and the pain rate will recorded in numerical range 0 (painless) to 9 (severe pain). One week after operation will be a visit to remove the sutures by surgeon then the situation of the Operation zone will examined clinically with checking and recording the effect of the suture on the indexes of swelling, redness and dehiscence. Inclusion: Patients who have been indication for impacted tooth extraction of mandible in two side with same dormancy and express their consciously tendency to cooperation with this plan. Exclusion: Present of pericoronal acute and chronic inflammation; used tablet except considered tablet; pregnancy, having systematic problems and individuals who have prohibition for this kind of medicine. Interventions: One side of patient’s mandible will be appointed as experimental group (vicryl plus suture) and the other side will be as control group (vicryl suture). Main variables are the rate of pain beginning, pain rate every 12,24 and 72 hours after surgery, the number of used tablets and redness, swelling and dehiscence level .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015092424167N1
Registration date: 2017-11-05, 1396/08/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-05, 1396/08/14
Registrant information
Name
Esshagh Lasemi
Name of organization / entity
Oral&Maxillofacial surgery Department-Dental Branch,Islamic Azad University,Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
e_lasemi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Researcher
Expected recruitment start date
2016-12-15, 1395/09/25
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To investigate the effect of vicryl and vicryl plus sutures on wound situation after lower jaw impacted third molars surgery
Public title
To investigate the effect of vicryl and vicryl plus sutures on wound situation after lower jaw impacted third molars surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients who have been indication for impacted tooth extraction of mandible in two side; same dormancy; express the consciously tendency to cooperate. Exclusion criteria: Present of pericoronal acute and chronic inflammation; used tablet except considered tablet; pregnant person; having systematic problems; individuals with prohibition to this used medicine.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Branch,Islamic Azad University
Street address
No. 4, 10th Neyestan St. , Pasdaran Ave.
City
Tehran
Postal code
19585175
Approval date
2016-11-21, 1395/09/01
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,9

Health conditions studied

1

Description of health condition studied
Impacted third Molar tooth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth

Primary outcomes

1

Description
pain rate after surgery
Timepoint
12,24 and 72 hours after surgery
Method of measurement
Questionnaire

Secondary outcomes

1

Description
the Operation zone will examined clinically for the indexes of swelling, redness and dehiscence.
Timepoint
One week after surgery
Method of measurement
Clinical exam

Intervention groups

1

Description
Control: group 2: suturing with Vicryl
Category
Prevention

2

Description
Cases: group 1: suturing with Vicryl plus
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Oral&Maxillofacial surgery Department-Dental Branch,Islamic Azad University,Tehran
Full name of responsible person
Kasra Naseri
Street address
No. 4, 10th Neyestan St. , Pasdaran Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dental Branch,Islamic Azad University,Tehran
Full name of responsible person
Kasra Naseri
Street address
Dental Branch,Islamic Azad University,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Branch,Islamic Azad University,Tehran
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
Dental Branch,Islamic Azad University,Tehran
Full name of responsible person
Kasra Naseri
Position
Researcher
Other areas of specialty/work
Street address
No. 4, 10th Neyestan St. , Pasdaran Ave.
City
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Fax
Email
naserikasra@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oral&Maxillofacial surgery Department-Dental Branch,Islamic Azad University,Tehran
Full name of responsible person
Dr Esshagh Lasemi
Position
Associated professor
Other areas of specialty/work
Street address
No. 4, 10th Neyestan St. , Pasdaran Ave.
City
Tehran
Postal code
19585175
Phone
+98 21 2256 4572
Fax
Email
e_lasemi@dentaliau.ac.ir ; elasemi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Oral&Maxillofacial surgery Department-Dental Branch,Islamic Azad University,Tehran
Full name of responsible person
Kasra Naseri
Position
Researcher
Other areas of specialty/work
Street address
No. 4, 10th Neyestan St. , Pasdaran Ave.
City
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Fax
Email
naserikasra@gmail.com
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
Loading...