Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ibrahim Nourwali
ORCID ID
Contact details
Taibah University
Dental college
Oral and Maxillofacial department
Madinah
42313-5141
Saudi Arabia
+966 550939364
ibrahim_germany@hotmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
TUCD-REC20160204
Study information
Scientific title
The influence of platelet-rich fibrin on post-surgical complications following the removal of impacted wisdom teeth
Acronym
Study hypothesis
There is no effect of platelet-rich fibrin on complications following surgical removal of lower impacted wisdom teeth
Ethics approval
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
Study design
Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
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
Phase
Drug names
Primary outcome measure
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])
Secondary outcome measures
On days 1, 2, 3, 7 and 15 post-operatively:
1. Swelling, assessed by the surgeon
Overall trial start date
05/02/2016
Overall trial end date
30/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Total final enrolment
20
Participant exclusion criteria
1. Pregnant women
2. Patients allergic to penicillin
3. Patients using other medications during the typical follow-up period
Recruitment start date
15/03/2016
Recruitment end date
15/06/2016
Locations
Countries of recruitment
Saudi Arabia
Trial 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
Sponsor information
Organisation
Taibah University
Sponsor details
College of Dentistry
Al Arkam Ibn Abi Al Arkam
Al-Madinah Al-Munawarah
Medina
42313-5141
Saudi Arabia
+966 14861888
TUCDREC@taibahu.edu.sa
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
31/12/2020
Participant level data
Other
Basic results (scientific)
Publication list