Assessing of the use of platelet-rich plasma (PRP) in improving function and healing in the treatment of mandibular condyle fractures by the closed reduction In traumatized patients
evaluation of PRP in improvement of function and haling in closed reduction of condylar fractures
Design
two arm parallel group randomised trial with double blinded on 64 pateints. randomization is performed with random allocation software
Settings and conduct
the patients with condylar fractures who referred to Imam Hossein or Vali-e-asr hospitals will divided in two groups. maximum mouth opening and laterusive movement of jaw is measured. Arch bar is placed in patients in both groups under general anesthesia. in study group, 10cc blood is taken from peripheral vein and centrifuged twice to extracted PRP. then, PRP is injected into the fracture area. MMF is performed in both groups. pain evaluate with visual analogue scale after surgery and immediately after MMF removal. maximum mouth opening and laterusive movement is measured immediately after MMF removal and 2 weeks after that in both groups. patients and evaluators do not have any information about injection or not injection of PRP.
Participants/Inclusion and exclusion criteria
patients who had condylar fractures in Imam Hosein and Vali-e- asr hospitals and underwent closed reduction, at least 18 years old, with repeatable and stable occlusion. patients should be have not any history of bone metabolism disorders or use of medications that affect on bone metabolism.
Intervention groups
in study group, after arch bar insertion, PRP is extracted from peripheral vein blood with centrifuge; and is injected into the fracture area
Main outcome variables
pain based on VAS, maximum mouth opening, laterusive movement of jaw
General information
Reason for update
Acronym
PRP
IRCT registration information
IRCT registration number:IRCT20190429043413N2
Registration date:2023-08-29, 1402/06/07
Registration timing:registered_while_recruiting
Last update:2023-08-29, 1402/06/07
Update count:0
Registration date
2023-08-29, 1402/06/07
Registrant information
Name
Pedram Bakhshaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 8141
Email address
bakhshaei.pedram@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-08, 1402/04/17
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing of the use of platelet-rich plasma (PRP) in improving function and healing in the treatment of mandibular condyle fractures by the closed reduction In traumatized patients
Public title
platelet-rich plasma (PRP) in mandibular condyle fractures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with at least 18 years old
patients who need close reduction of condylar fractures
stable and repeatable occlusion for maxillomandibular fixation(MMF)
patients without any bone disorders like arthritis
no history of bisphosphonate use
Exclusion criteria:
unstable occlusion for MMF
condylar displacement into cranial fossa
extracapsular displacement
contraindication for MMF like seizure of intolerance of patients
metabolic bone disorders or arthritis
use of medications that affect on bone metabolism
open reduction and internal fixation of fractures
inability to follow up the patients
growing patients
history of jaw or condylar surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
in this study, random allocation software was used for simple randomization. after allocation in 2 groups with 32 persons, concealed in sequentially numbered, sealed, opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants , after choose of one sealed envelopes, place on one of groups and because of doing procedure under general anesthesia, they don't have any information about PRP injection into the fracture site. Also, evaluators don't know what is the group of any patient and PRP injection. Data analyzer analysis data without any information about groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of directorate of health, rescue and treatment of police headquarter of Iran
Street address
Edward Brown st. ,North Kargar st. , Enghelab sq.
City
Tehran
Province
Tehran
Postal code
1417944661
Approval date
2023-07-06, 1402/04/15
Ethics committee reference number
IR.SBMU.TEB.POLICE.REC.1402.013
Health conditions studied
1
Description of health condition studied
mandibular condyle fracture
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible
Primary outcomes
1
Description
pain assessment
Timepoint
the day after surgery, immediately after MMF removal
Method of measurement
based on visual analogue scale (VAS)
2
Description
maximum mouth opening
Timepoint
before treatment, immediately after MMF removal, 2 weeks after MMF removal
Method of measurement
inter incisal distance in millimeters
3
Description
laterusive movement of jaw
Timepoint
before treatment, immediately after MMF removal, 2 weeks after MMF removal
Method of measurement
maxillary and mandibular dental midline displacement in laterusive movement in millimeters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group, PRP is injected into the fracture area. Patients in intervention group, underwent arch bar insertion under general anesthesia. then, 10cc venal blood is taken and PRP is extracted. About 2 cc of PRP is injected into the fracture area( palpitation of joint for detect the injection position). for 2-4 weeks, patients have MMF.
Category
Treatment - Drugs
2
Description
Control group: no intervention, just usual fracture treatment. Under general anesthesia, arch bar is inserted and then for 2-4 weeks patients have MMF
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Pedram Bakhshaei
Street address
Madani st. , Imam ali exp.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
info@ehmc.ir
2
Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Pedram Bakhshaei
Street address
opposite Zafar st. , Vali Asr st.
City
Tehran
Province
Tehran
Postal code
1417944661
Phone
+98 21 8123 5481
Email
tebbehdad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
directorate of Health, Rescue and Treatment of Police Headquarter of Islamic Republic of Iran
Full name of responsible person
Reza Mohammadi
Street address
opposite Zafar st. , Vali asr st.
City
Tehran
Province
Tehran
Postal code
1417944661
Phone
+98 21 8123 5481
Email
tebbehdad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
directorate of Health, Rescue and Treatment of Police Headquarter of Islamic Republic of Iran
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pedram Bakhshaei
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
oral & maxillofacial surgery
Street address
dental faculty, Daneshjoo blv, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
bakhshaei.pedram@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pedram Bakhshaei
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
oral & maxillofacial surgery
Street address
dental faculty, Daneshjoo blv, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
bakhshaei.pedram@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pedram Bakhshaei
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
oral & maxillofacial surgery
Street address
dental faculty, Daneshjoo blv, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
bakhshaei.pedram@gmail.com
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