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Investigating the effect of the amount of serum used on the complications after third Molar surgery

Protocol summary

Study aim
Determining the effect of the amount of serum used on the complications after third Molar surgery
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 2, on 300 patients. A random number table will be used for randomization.
Settings and conduct
The aim of this study was to determine the effect of the amount of serum used on complications after third molar surgery. This study is a single blind, randomized clinical trial. The study population is patients undergoing third molar surgery. Patients will receive randomly 20, 40, and 60 ml of normal sterile saline in 3 intervention groups. The patient will be unaware of the group assigned to him.
Participants/Inclusion and exclusion criteria
Inclusion criteria for participants: Patients undergoing mandibular third molar surgery, They should be in the moderate surgical group, The existence of a third mandibular molar, the occlusion of which has been confirmed by panoramic radiography. Exclusion criteria for participants: drug use, alcohol use, smoking, the presence of underlying diseases that interfere with wound healing, such as systemic diabetes, gastrointestinal diseases, kidney disease and heart and lung disease, use of drugs that cause dry mouth.
Intervention groups
Intervention group 1: Patients will receive 20 ml of normal sterile saline. Intervention group 2: Patients will receive 40 ml of normal sterile saline. Intervention group 3: Patients will receive 60 ml of normal sterile saline.
Main outcome variables
Main Outcomes of the Study: Pain and Swelling.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191127045516N3
Registration date: 2021-01-02, 1399/10/13
Registration timing: registered_while_recruiting

Last update: 2021-01-02, 1399/10/13
Update count: 0
Registration date
2021-01-02, 1399/10/13
Registrant information
Name
hamed Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 2842
Email address
hamed.nazari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the amount of serum used on the complications after third Molar surgery
Public title
Effect of serum on the complications of third Molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing mandibular third molar surgery They should be in the moderate surgical group. The existence of a third mandibular molar, the occlusion of which has been confirmed by panoramic radiography.
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Patients receive a random number using the random number table according to their priority entry to the center that matches the numbers on the sealed envelopes. Inside the sealed envelopes is one of the codes A, B and C. A represents the first intervention group that will receive 20 ml of sterile normal saline, B represents the second intervention group that will receive 40 ml of sterile normal saline, and C represents the third intervention group that will receive 60 ml of normal sterile saline.
Blinding (investigator's opinion)
Single blinded
Blinding description
Study participants are not aware of their assigned group and will be unaware of the amount of serum used. Of course, they participate in the study with informed consent.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research, Building No. 2, Kermanshah University of Medical Science, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.KUMS.REC.1399.806

Health conditions studied

1

Description of health condition studied
Mandibular third molar surgery
ICD-10 code
K00.1
ICD-10 code description
Supernumerary teeth

Primary outcomes

1

Description
Pain
Timepoint
Immediately, 2 and 7 days after surgery
Method of measurement
Visual Analogue Scale (VAS)

2

Description
Inflation
Timepoint
Immediately, 2 and 7 days after surgery
Method of measurement
self report

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will receive 20 ml of normal sterile saline 5 minutes after surgery. The size of the syringe used for rinsing with serum is 20 ml.
Category
Treatment - Drugs

2

Description
Intervention group: Patients will receive 40 ml of normal sterile saline 5 minutes after surgery. The size of the syringe used for rinsing with serum is 40 ml.
Category
Treatment - Drugs

3

Description
Intervention group: Patients will receive 60 ml of normal sterile saline 5 minutes after surgery. The size of the syringe used for rinsing with serum is 60 ml.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental College
Full name of responsible person
Hamed Nazari
Street address
Front of the Post Office, Dr. Shariati St
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 7151
Email
Nazari.hamed67@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Vice Chancellor for Research, Building No. 2, Kermanshah University of Medical Science, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 6835
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Hamed Nazari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Front of the Post Office, Dr. Shariati St
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 7151
Email
Nazari.hamed67@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hamed Nazari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Front of the Post Office, Dr. Shariati St
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 7151
Email
Nazari.hamed67@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shima Zarie
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
ّFront of the Post Office, Dr. Shariati St
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 7151
Email
hima.a.h999@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
It is accessible to researchers working in academic and scientific institutions for further research.
From where data/document is obtainable
They can request the data by sending an email to Dr. Hamed Nazari. Nazari.hamed67@gmail.com
What processes are involved for a request to access data/document
After sending the data request email, study partners will make the decision.
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