Condition category
Oral Health
Date applied
06/11/2020
Date assigned
09/11/2020
Last edited
09/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://www.taibahu.edu.sa/Pages/AR/Home.aspx

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

Publication citations

Additional files

Editorial Notes

06/11/2020: Trial’s existence confirmed by Taibah University.