The influence of platelet-rich fibrin on pain, bleeding, swelling, and soft tissue healing after tooth extraction

ISRCTN	ISRCTN13878305
DOI	https://doi.org/10.1186/ISRCTN13878305
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	TUCD-REC20160204
Sponsor	Taibah University
Funder	Investigator initiated and funded

Submission date: 06/11/2020
Registration date: 09/11/2020
Last edited: 15/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Platelet-rich fibrin (PRF) is a biomaterial that is prepared from the patient’s own blood and can be used as a membrane for root coverage purposes after tooth extraction.
The study aimed to assess the influence of Plasma Rich Fibrin (PRF) in post-transition extraction on pain, bleeding, swelling, and soft tissue healing.

Who can participate?
Patients between 18 and 40 years of age having molar extraction.

What does the study involve?
Participants will be randomly allocated to receive either PRF or saline solution applied to the area following tooth extraction and will be followed up for 15 days.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Taibah University College of Dentistry (Saudi Arabia)

When is the study starting and how long is it expected to run for?
February 2016 to June 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Ibrahim Nourwali
ibrahim_germany@hotmail.com

Contact information

Dr Ibrahim Nourwali
Scientific

Taibah University
Dental college
Oral and Maxillofacial department
Madinah
42313-5141
Saudi Arabia

Phone	+966 550939364
Email	ibrahim_germany@hotmail.com

Study information

Primary study design	Interventional
Study design	Interventional randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The influence of platelet-rich fibrin on post-surgical complications following the removal of impacted wisdom teeth
Study objectives	There is no effect of platelet-rich fibrin on complications following surgical removal of lower impacted wisdom teeth
Ethics approval(s)	Approved 29/02/2016, Taibah University College of Dentistry REC (Al Arkam Ibn Abi Al Arkam, Al-Madinah Al-Munawarah, Medina, 42313-5141, Saudi Arabia; +966 552884839; TUCDREC@taibahu.edu.sa), ref: TUC-REC20160204
Health condition(s) or problem(s) studied	Pain following wisdom tooth extraction
Intervention	During all the surgical procedures, all the extractions were accomplished by elevating a full-thickness mucoperiosteal flap. Following the reflection of the mucoperiosteal flap in the conventional dento-alveolar surgery with or without PRF, the osteotomy was carried out with a 1.6 mm round bur attached to a Kavo straight surgical hand-piece, using copious irrigation. All of the teeth were completely removed. In the study group, following the tooth extraction, the PRF was implanted into the extraction socket. In the control group, a sterile physiologic saline solution was used to wash the extraction sockets. The post-extraction sockets were closed by 3–0 polyglycolic acid non-resorbable sutures were used. Randomization of participants into groups using sealed envelopes.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Measured at 1, 2 and 6 h post-operatively: 1. Pain (Visual Analogue Scale [0 to 5]) 2. Bleeding ((Visual Analogue Scale [0 to 4])
Key secondary outcome measure(s)	On days 1, 2, 3, 7 and 15 post-operatively: 1. Swelling, assessed by the surgeon
Completion date	30/06/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
Total final enrolment	20
Key inclusion criteria	1. Presence of unilateral or bilateral premolars or molars indicated for extraction 2. American Society of Anaesthesiologists (ASA) physical status classification; ASA grade I
Key exclusion criteria	1. Pregnant women 2. Patients allergic to penicillin 3. Patients using other medications during the typical follow-up period
Date of first enrolment	15/03/2016
Date of final enrolment	15/06/2016

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

Taibah University College of Dentistry (TUCoD)

Al Arkam Ibn Abi Al Arkam
Departments of Oral and Maxillofacial Surgery
Al-Madinah Al-Munawarah
Madinah
42313-5141
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		13/03/2021	15/03/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/03/2022: Publication reference added.
06/11/2020: Trial’s existence confirmed by Taibah University.