Determining the effect of PRF on pain, swelling, and ecchymosis after impacted third molar surgery
Design
An open label randomized clinical trial study with parallel groups and phases 3 on 34 patients. Randomization will be done with the block randomization method using Random allocation software.
Settings and conduct
In this study open label, patients requiring surgery for impacted third molars who are referred to the Oral and Maxillofacial Surgery Clinic of Zahedan Dental School will be included.
Participants/Inclusion and exclusion criteria
In this study, patients over 18 years of age requiring surgery for impacted third molars will be included. Major exclusion criteria include coagulation disorders, allergy to lidocaine, use of psychotropic and anticoagulant drugs, pregnancy, and breastfeeding.
Intervention groups
For patients in the intervention group, following anesthesia administration via injection of the local anesthetic 2% Lidocaine, a full-thickness mucoperiosteal flap will be raised with a distal releasing incision relative to the third molar to achieve access. Following the removal of the impacted tooth and irrigation of the socket with a minimum of 30 cc of normal saline, the prepared Platelet-Rich Fibrin (PRF) derived from the patient's blood sample will be placed into the socket. The flap will subsequently be closed using simple sutures with non-absorbable 3-0 silk suture material, which will be removed one week post-surgery. In the control group, routine treatment will be performed.
Identical postoperative measures will be implemented for all patients, including analgesics (Noufen/Ibuprofen as needed for pain), antibiotics (Amoxicillin 500 mg every 8 hours), and 0.2% Chlorhexidine mouthwash every 12 hours for one week.
Main outcome variables
Pain; swelling and ecchymosis
General information
Reason for update
Acronym
PRF(Platelet Rich Fibrin)
IRCT registration information
IRCT registration number:IRCT20250428065513N1
Registration date:2025-11-05, 1404/08/14
Registration timing:prospective
Last update:2025-11-05, 1404/08/14
Update count:0
Registration date
2025-11-05, 1404/08/14
Registrant information
Name
shirin haghighimoghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3337 2151
Email address
shirinhaghighi.m@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of Platelet-Rich Fibrin (PRF) on pain, swelling, and ecchymosis after impacted third molar surgery
Public title
Studying the effect of PRF on outcomes of impacted third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's impacted third molar may require surgery, as determined by the dentist.
َAged over 18 years
Exclusion criteria:
Coagulation disorders
Allergy to the anesthetic lidocaine
Use of psychotropic and anticoagulant drugs
Pregnancy and breastfeeding
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered (34 patients), and then in the block section, the Block randomization method will be selected. Patients will be allocated in intervention or control groups based on generated numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
An open-label randomized clinical trial study with parallel groups and phases 3 on 34 patients. Randomization will be done with the block randomization method using Random allocation software.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences., Doctor Hesabi square. Khalij Fars Blvd., Zahedan., Iran.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
-
Approval date
2025-10-05, 1404/07/13
Ethics committee reference number
IR.ZAUMS.REC.1404.221
Health conditions studied
1
Description of health condition studied
Impacted third molar surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Third, seventh, and twenty-first days after surgery
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Swelling
Timepoint
Before the intervention and on the third, seventh, and twenty-first days after surgery
Method of measurement
The numerical value of the swollen area on the face, measured by vertical and horizontal indicators with calipers.
3
Description
Ecchymosis
Timepoint
Third, seventh, and twenty-first days after surgery
Method of measurement
Skin discoloration caused by blood leaking from blood vessels into the subcutaneous tissues, measured with a caliper.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For patients in the intervention group, following anesthesia administration via injection of the local anesthetic 2% Lidocaine, a full-thickness mucoperiosteal flap will be raised with a distal releasing incision relative to the third molar to achieve access. Following the removal of the impacted tooth and irrigation of the socket with a minimum of 30 cc of normal saline, the prepared Platelet-Rich Fibrin (PRF) derived from the patient's blood sample will be placed into the socket. The flap will subsequently be closed using simple sutures with non-absorbable 3-0 silk suture material, which will be removed one week post-surgery. Postoperative care will be including analgesics (Noufen/Ibuprofen as needed for pain), antibiotics (Amoxicillin 500 mg every 8 hours), and 0.2% Chlorhexidine mouthwash every 12 hours for one week.
Category
Treatment - Surgery
2
Description
Control group: In the control group, routine treatment will be performed.Postoperative care will be including analgesics (Noufen/Ibuprofen as needed for pain), antibiotics (Amoxicillin 500 mg every 8 hours), and 0.2% Chlorhexidine mouthwash every 12 hours for one week.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacial Surgery Clinic, Zahedan Dental School
Full name of responsible person
Dr.Mehrdad Shahraki
Street address
Faculty of Dentistry., Azadeghan Shargh Ave., Zahedan., Iran.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
mehrdadsh409@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Ansari Moghaddam
Street address
Zahedan University of Medical Sciences., Doctor Hesabi square. Khalij Fars Blvd., Zahedan., Iran.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3337 2117
Email
ansarimohgaddam_a@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Shahraki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry., Azadeghan Shargh Ave., Zahedan., Iran.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3337 2117
Email
mehrdadsh409@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Mehrdad Shahraki
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry., Azadeghan Shargh Ave., Zahedan., Iran.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3337 2117
Email
mehrdadsh409@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Shahraki
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry., Azadeghan Shargh Ave., Zahedan., Iran.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3337 2117
Email
mehrdadsh409@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD