Efficacy of platelet-rich plasma in bone regeneration after surgical removal of odontogenic cycts
Design
Patients with odontogenic cysts will be divided into two groups of experimental and control. Fifty-four milliliters of whole blood with citrate-phosphate-dextrose will be drawn into a sterile tube and will centrifuge for 12 minutes at 3200 rpm and 5600 rpm Platelet Concentration System. The experimental group will receive a platelet-rich plasma at the site of the lesion, and the control group will receive no platelet-rich plasma. Patients in both groups will be followed up for 4 months to compare the osteogenesis at the site of the lesion.
Settings and conduct
26 patients will be selected from dental clinic of Tabriz University and private clinic of executive researcher, consecutively. Double-blind method will be used to blind patients and researchers. For this, digital codes produced by a computer will be used to hide the real identity of the patients.
Participants/Inclusion and exclusion criteria
Patients with no history of previous surgery in the site;
Patients with no history of systemic disease;
being free of any infection and inflammation;
Patients who involve in controlling visits on regular basis.
Intervention groups
The experimental group will receive a platelet-rich plasma at the site of the lesion.
The control group will receive no platelets-rich plasma
Main outcome variables
Defect diameter befor and after surgery for ossification rate; Evaluation time; Gery level histogram of defect for bone density
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171108037316N1
Registration date:2018-01-12, 1396/10/22
Registration timing:retrospective
Last update:2018-01-12, 1396/10/22
Update count:0
Registration date
2018-01-12, 1396/10/22
Registrant information
Name
reza khorshidi
Name of organization / entity
tabriz medical science university
Country
Iran (Islamic Republic of)
Phone
+98 413355966
Email address
khorshidir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of platelet rich plasma (PRP) on the quantity of the osteogenesis after the removal of odontogenic cysts
Public title
Effect of platelet rich plasma on osteogenesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with no history of previous surgery in the site.
Patients with no history of systemic conditions, and being infection and inflammation free.
Patients who involve in controlling visits on regular basis.
Exclusion criteria:
Age
From 24 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is used to randomize patients into control and experiment groups. To do this, random number table is used to produce disorganized numbers in order to assign patients to one of the groups. Reading method is up to down. Odds and even numbers are assigned to patients in control and experiment groups, respectively. For allocation concealment, due to patients selection from two sites, central randomization is used to prevent acknowledgement about groups before patients’s assignment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind method will be used to blind patients and researchers. Also, health stuffs will not be aware of classification of patients. For this, digital codes produced by a computer will be used to hide the real identity of the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz Faculty of Dentistry
Street address
Ethics committee of Tabriz Faculty of Dentistry, Central Organization No. 2, Tabriz University of Medical Sciences, University Main St., Golgasht St, Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2016-12-20, 1395/09/30
Ethics committee reference number
IR.TBZMED.REC.1395.995
Health conditions studied
1
Description of health condition studied
Odontogenic cysts
ICD-10 code
k09.0
ICD-10 code description
Developmental odontogenic cysts
Primary outcomes
1
Description
Ossification rate
Timepoint
Postsurgical, 1 month after surgery, 2.5 months after surgery, 4 months after surgery.
Method of measurement
Using Cone beam computed tomography.
Secondary outcomes
1
Description
Bone density increase
Timepoint
Postsurgical, 1 month after surgery, 2.5 months after surgery, 4 months after surgery
Method of measurement
Using cone beam computed tomography.
Intervention groups
1
Description
Intervention group: Odontogenic cyst enucleation and PRP injection to the site.45 milliliters of whole blood with Citrate-phosphate-dextrose is drawn into a sterile tube and centrifuged for 12 minutes at 2400 rpm and 5600 rpm for PRP preparation then is injected to the surgical site.
Category
Treatment - Surgery
2
Description
Control group: Odontogenic cyst enucleation without PRP injection to the site
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Clinic of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reza Khorshidi
Street address
Dentistry Clinic of Tabriz University of Medical Sciences, Tabriz Faculty of Dentistry, University Main St., Golgasht St., Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7314
Email
khorshidir@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reza Khorshidi
Street address
Deputy of Research, Tabriz University of Medical Sciences, University Main St., Golgasht St., Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7314
Email
khorshidir@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Faranak Vakili
Position
Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz Faculty of Dentistry,Tabriz University of Medical Sciences, University Main St., Golgasht St., Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Fax
Email
faranak.vakili714@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reza Khorshidi
Position
Oral and maxillofacial surgeon
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Faculty of Dentistry,Tabriz University of Medical Sciences, University Main St., Golgasht St., Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Fax
Email
khorshidir@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reza Khorshidi
Position
Oral and maxillofacial surgeon
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Faculty of Dentistry,Tabriz University of Medical Sciences, University Main St., Golgasht St., Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 33355921
Fax
Email
khorshidir@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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