Protocol summary

Study aim
To evaluation clinical inflammatory indicator in two types of suture (Vicryl and Chromic Catgut)
Design
This study is a prospective, single-blind clinical trial.
Settings and conduct
Candidate Patients for Impacted Third Molar Surgery Referred to Surgery Department of Shahid Sadoughi Dental School, Yazd, Iran. After removal of the third molar to the mesial side of the incision is sutured by Vicryl 4-0(Supa, Iran) and in the distal and the distal side is sutured by Chromic Catgut suture 4-0 (Supa, Iran) one month after the first surgery. In all people the suture technique is the same and simple.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients referred to Oral and Maxillofacial Surgery Department of Dental School in Yazd, Were the candidate to third molar extraction . Absence of systemic diseases; Exclusion criteria: Patients who do not refer for dental surgery on both sides.
Intervention groups
Vicryl suture: one side (mesial) is sutured with Vicryl suture. Chromic Catgut suture: one side (distal) is sutured with Chromic Catgut.
Main outcome variables
Inflammation index; Gingival index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191014045101N2
Registration date: 2020-03-03, 1398/12/13
Registration timing: retrospective

Last update: 2020-03-03, 1398/12/13
Update count: 0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Mostafa Gavahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 6975
Email address
mgdds@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2019-10-09, 1398/07/17
Actual recruitment start date
2019-04-25, 1398/02/05
Actual recruitment end date
2019-12-06, 1398/09/15
Trial completion date
2019-12-17, 1398/09/26
Scientific title
Assessment of clinical inflammatory indicator in two types of suture (Vicryl and Chromic Catgut)
Public title
Comparison of Tissue Reaction to two types of Suture
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to Oral and Maxillofacial Surgery Department of Dental School in Yazd, Were the candidate to third molar extraction Absence of systemic diseases
Exclusion criteria:
Patients who do not refer for dental surgery on both sides
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: The coin was randomly sutured mesial by Vicryl suture and distal by Chromic Catgut suture.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blindness: This study is single-blind because the histological examination of the specimens is performed by other than the therapist.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Shahid Sadoughi University of Medical Sciences Yazd
Street address
Bahonar Square., Central Building of University
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.SSU.REC.1397.174

Health conditions studied

1

Description of health condition studied
Foreign body reaction
ICD-10 code
K06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified

Primary outcomes

1

Description
Histologic inflammation of the gingiva
Timepoint
Third, fifth and seventh days
Method of measurement
Gingival Index

Secondary outcomes

1

Description
Clinical Inflammation of the gingiva
Timepoint
Third, fifth and seventh days
Method of measurement
Inflammation index

Intervention groups

1

Description
Intervention group: Vicryl suture 4-0 (Supa, Iran)
Category
Treatment - Surgery

2

Description
Intervention group: Chromic Catgut suture 0-4 (Supa, Iran)
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Surgery, Shahid Sadoughi Dental School, Yazd, Iran
Full name of responsible person
Mostafa Gavahi
Street address
Dental School, Dahe Fajr Blvd,Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 8813
Email
pajoheshdentyazd@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masuood Mirzaee
Street address
Deputy for research., Central Building of Shahid Sadoughi University of Medical Sciences., Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mostafa Gavahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School., Dahe Fajr Blvd.,Yazd
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3827 9615
Email
mgdds@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mostafa Gavahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School., Dahe Fajr Blvd.,Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3827 9615
Email
mgdds@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Nouri Shadkam
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental School., Dahe Fajr Blvd., Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
Zahransh1373@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
Title and more details about the data/document
The primary outcome data is shared
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Perform meta-analysis and systematic review
From where data/document is obtainable
Dr Mostafa Gavahi, Dental School, Dahe Fajr Blvd,Yazd, postal code: 8914881167
What processes are involved for a request to access data/document
Send email to Zahra Nouri Shadkam by email: Zahransh1373@yahoo.com
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